Mild Cognitive Impairment (MCI)NCT07887737
Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment
A study testing Abbott St Jude Medical Infinity™ in people with Mild Cognitive Impairment (MCI) and Mild Cognitive Impairment (MCI) Amnestic, run by University of Texas Southwestern Medical Center.
Trial summary
This trial is a 12-month safety and feasibility study, enrolling up to six participants. These participants will serve as their own controls, structured in multiple parts that follow an initial short-term stereo electroencephalography (SEEG) mapping period. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Amnestic, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
- What is being tested?
- Abbott St Jude Medical Infinity™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (non-pregnant) between ages 60 and 85.
- Meets NIA-AA core clinical criteria for MCI due to Alzheimer's Disease.
- Determination by the investigator, based on clinical judgment and review of medical history, neurological examination, cognitive profile, and available clinical data, that Alzheimer's Disease is the primary suspected etiology.
- Absence of other psychiatric or physical conditions that could interfere with the study.
- Stable medication regimen for 4 weeks preceding surgery; participants currently receiving anti-amyloid therapies may enroll if they are able and willing to pause infusions for at least 12 weeks prior to study initiation and for the duration of the study.
- Other medical conditions must be stable for at least 6 months prior to SEEG Implantation.
- Able and willing to give informed consent or have a Legally Authorized Representative who is able to sign the informed consent form.
- Able to have a study partner(s) or close relative(s) present for discussions about the study
Who cannot join
- Active alcohol or substance use disorder within 6 months of entering the Screening Phase, excluding nicotine. Urine drug test positive for illicit drugs.
- Neurological/Medical condition that makes the participant, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation).
- Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital brain malformation, neuro-developmental disorder , or other factors that predispose seizures such as an active eating disorder).
- Cognitive symptoms that are not be better explained by delirium, unstable psychiatric illness, active substance use disorder, major untreated sleep disorder, acute neurologic illness, or other medical condition that, in the investigator's judgment, is the primary cause of the impairment.
- Brain structural MRI abnormalities outside of expected pathology associated with Mild Cognitive Impairment.
- Any medical contraindication to surgery such as infection.
Show all 23Show fewer
- Coagulopathy: Bleeding propensity and/or one of the following: INR > 1.5; prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec; platelet count < 100×103 /uL
- Uncontrolled hypertension (systolic > 145mmHg and/or diastolic > 90 mmHg), demonstrated on each of three repeated measurements taken within one hour regardless of whether or not the participant is taking antihypertensive medications.
- Participation in another drug, device, or biological study within 90 days.
- Current implanted neural stimulation devices including spinal cord stimulators and deep brain stimulators.
- Need for Diathermy.
- Chronic use of anticoagulant or anti-platelet agents that cannot be safely stopped for a sufficient duration (minimum 2.5 weeks) in the peri-operative period.
- Any Psychiatric/Neurological/Medical condition that makes the participant, in the opinion of the Investigator, a poor candidate. These may be but are not limited to a DSM-5 diagnosis of schizophrenia, bipolar disorder, obsessive-compulsive disorder.
- Moderate to severe depressive symptoms, defined as a GDS-15 score ≥11 at screening, or investigator judgment that depressive symptoms are unstable, severe, or likely to interfere with study participation or interpretation of cognitive outcomes.
- High risk of suicide, defined as any of the following on the Columbia Suicide Severity Rating Scale (C-SSRS) short form at screening: active suicidal ideation with intent to act, active suicidal ideation with a specific plan and intent, suicidal behavior within the past 3 months or investigator judgment that the participant is at imminent or clinically significant risk for self-harm.
- A separate cardiac condition that, in the opinion of a study physician, would present an unacceptable risk of undergoing general anesthesia.
- Any clinical impression reflective of disease pathologies indicated by the list below is exclusionary
- Frontotemporal degeneration spectrum disorders (e.g., behavioral-variant FTD, primary progressive aphasia)
- Dementia with Lewy bodies / Parkinson disease dementia
- Cerebral amyloid angiopathy (moderate to severe)
- Eligibility Note:
- Participants will be excluded if the investigator determines that cognitive impairment is primarily attributable to vascular cognitive impairment, Lewy body disease, frontotemporal degeneration, Parkinson's disease, traumatic brain injury, delirium, unstable psychiatric illness, medication effects, substance use, or another non-AD neurologic or systemic condition.
- A prior or concurrent diagnosis of Alzheimer's disease is permitted only if the participant is clinically at the MCI / mild neurocognitive disorder stage, rather than dementia stage. In other words, participants with "MCI due to Alzheimer's disease," "prodromal Alzheimer's disease," or "early Alzheimer's disease" may be included if functional independence is preserved.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tash Mupambo, MS contact
About this study
This trial is a 12-month safety and feasibility study, enrolling up to six participants. These participants will serve as their own controls, structured in multiple parts that follow an initial short-term stereo electroencephalography (SEEG) mapping period.
During this trial we aim to demonstrate the safety of acute and chronic network-guided stimulation in Mild Cognitive Impairment by evaluating adverse effects, tolerability, and feasibility during both the short- term SEEG mapping phase and subsequent permanent DBS therapy.
Read more
In addition to safety measures, therapeutic results as follows are to be tested for: (1) Develop patient-specific stimulation parameters for the treatment of MCI, as well as develop and test memory state classifiers by enrolling six individuals to undergo intracranial mapping (SEEG). We will use targeted memory tasks to generate neural data needed for state distinctions, and conduct a systematic parameter search to identify and develop optimal settings for each patient. (2) Assess efficacy of open loop stimulation by delivering a fixed open loop protocol based on the parameters discovered earlier, while SEEG electrodes remain in place, and testing the efficacy of the trained classifier to detect favorable brain states. (3) Evaluate chronic DBS therapy by implanting a permanent system in participants who show an acute beneficial response to assess long term outcomes. (4) Assess therapeutic outcomes and refine protocols by measuring reductions in memory-related impairment.
The above findings will guide further refinement of the device and protocol.
Read the detailed description
This is a 12-month, within-subject safety and feasibility study evaluating network-guided deep brain stimulation (DBS) for Mild Cognitive Impairment (MCI), enrolling up to six participants who serve as their own controls. The protocol proceeds through a screening phase, a short-term intracranial mapping period using stereo-electroencephalography (SEEG), permanent DBS implantation, an open-label programming phase, a double-blind discontinuation phase, and long-term follow-up.
Screening and Presurgical Baseline (up to 16 weeks before implantation). Eligible participants undergo a thorough standardized neuropsychological evaluation, including demographic and medical/psychiatric history, physical and mental status exams, vital signs, laboratory testing, and medication review (with specific attention to anti-amyloid monoclonal antibody therapy, which must be paused at least 12 weeks before surgery).
Participants undergo CT and 3T MRI imaging (structural, diffusion tractography, and resting-state functional sequences) for surgical planning. A presurgical baseline visit within 1-4 weeks of surgery repeats key labs, adds cardiac risk assessment (EKG, anesthesiology evaluation), confirms surgical clearance, and administers neuropsychological battery assessing processing speed, working memory, executive function, verbal and visual memory, and language.
SEEG Implantation and Inpatient Mapping (Day 0-7). Using standard stereotactic technique and ROSA planning software, 12 intracranial electrode trajectories (six per hemisphere) are placed targeting the anterior and posterior hippocampus, anterior and posterior cingulate cortex, anterior insula, and orbitofrontal cortex. Electrodes are measured using the NeuroPort recording system (Blackrock Microsystems, FDA-cleared under 510(k) K09095), sampling approximately 160 contacts at 2 kHz. All participants are monitored by the clinical staff, and maintained on antibiotics during admission.
Three experiments are conducted during the inpatient stay:
- Experiment 1 (Brain-state modeling): Participants perform memory tasks (CVLT-III, associative memory, serial recall, spatial navigation) to build patient-specific neural classifiers distinguishing favorable from unfavorable memory-related brain states.
- Experiment 2 (Parameter search): A grid-search paradigm delivers biphasic stimulation across target regions at varying amplitude (1-3 mA) and frequency, held within a fixed safety ceiling (200 µs pulse width, maximum charge density of 30 µC/cm²/phase, well under the Shannon safety criterion). Stimulation effects are evaluated against the classifier to identify parameters that shift brain activity toward a favorable memory state, with continuous epileptologist oversight for after-discharges and cardiopulmonary monitoring throughout.
- Experiment 3 (Open-loop stimulation): Using parameters identified in the search phase, two sessions combine a stimulation-free baseline with alternating active and sham stimulation blocks in a 2×2 design. Verbal memory (HVLT-R) and classifier-based neural biomarkers serve as outcome measures, reflecting the expectation that full therapeutic benefit may require weeks of chronic stimulation.
DBS Implantation (Day 7 ± 3 days). Participants meeting criteria proceed to explant of the SEEG electrodes and implantation of two permanent DBS leads (one per hemisphere, at sites selected from mapping data) along with a subcutaneous pulse generator, performed under general anesthesia with standard perioperative antibiotic prophylaxis. A post-procedure CT confirms absence of complications (e.g. hemorrhage) before discharge.
Postoperative Visits and Device Activation (Day 14 and Day 21). A one-week post-operative visit assesses wound healing and neurological status, with weekly follow-up thereafter for monitoring purposes. Approximately two weeks post-implant, device activation occurs using the rank-ordered parameter sets derived from inpatient testing. Predefined stopping/delay criteria apply (e.g., ≥4-point MoCA worsening confirmed at 48 hours, ≥10-point MADRS increase, or new suicidality), triggering deferral and biweekly reassessment until baseline status is re-established.
Open-Label Phase (Months 1-8). Programming is individualized based on inpatient-derived parameters, with amplitude titrated to balance benefit and side effects. Periodic visits track mood, cognition, and function (GAD-7, MADRS, C-SSRS, MoCA, ECog, CDR, CGI-S, HVLT-R), and the same stopping rules apply if worsening is observed on two consecutive visits, prompting stimulation cessation and supportive care.
Double-Blind Discontinuation (Weeks 33-45). All participants, regardless of open-label response, enter a blinded discontinuation period of up to 12 weeks to further characterize effects.
Long-Term Follow-Up. Participants are followed annually after completion of the blinded discontinuation phase to monitor device safety and intended clinical outcomes.
Across all phases, primary objectives are to characterize the safety, tolerability, and feasibility of acute (SEEG-based) and chronic (DBS) network-guided stimulation in MCI. Secondary objectives include developing patient-specific stimulation parameters and memory-state classifiers, testing open-loop stimulation efficacy, and evaluating longer-term cognitive and functional outcomes to inform refinement of the stimulation protocol and device.
- Conditions
- Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Amnestic, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Memory Deficit, Memory Disorder
- Being tested
- Abbott St Jude Medical Infinity™
- Keywords
- Deep Brain Stimulation, Neuromodulation of Memory, Memory Disorder, Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott St Jude Medical Infinity™Device
Subjects will be deactivated (stimulation no longer occurs) from stimulation/ continue stimulation with the Abbott St Jude Medical Infinity™. Weekly assessments on primary memory measures will occur.
| Study group | Role | What they receive |
|---|---|---|
| Deactivation of Stimulation with the Abbott St Jude Medical Infinity™ | Placebo comparator | Subjects will be deactivated (stimulation no longer occurs) from stimulation with the Abbott St Jude Medical Infinity™. Weekly assessments on primary memory measures will occur. Receives: Device: Abbott St Jude Medical Infinity™ |
| Stimulation Continuation with Abbott St Jude Medical Infinity™ | Experimental | Subjects will continue stimulation (stimulation occurs) with the Abbott St Jude Medical Infinity™ based on parameters developed in the inpatient stay. Weekly assessments on primary memory measures will occur. Receives: Device: Abbott St Jude Medical Infinity™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate device safety
Description: The primary objective is to demonstrate safety of acute and chronic network guided stimulation for Mild Cognitive Impairment (MCI). This is determined if participants with the Deep Brain Stimulation Device demonstrate no significant device related serious adverse events (SAE). Device safety will be measured by number of reported SAE's in years 2 through 4.
Measured: 4 years
Secondary outcomes (16)
RCI - ECog
The Everyday Cognition Scale (ECog) measures the ability to perform everyday tasks that demand memory, language, visuospatial abilities, planning, organization, and divided attention. The ECog consists of a global and domain scores for each of the previously described categories, and is scored as follows: 1= better or no change compared to 10 years earlier, 2= questionable/occasionally worse compared to 10 years earlier, 3= consistently a little worse compared to 10 years earlier, 4= consistently much worse compared to 10 years earlier. Thus, the lower the overall score is on this measure at both the global and domain score level, the better one is performing with respect to their cognition.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 35-39 (3-6 weeks post-intervention)
RCI - ECog
The Everyday Cognition Scale (ECog) measures the ability to perform everyday tasks that demand memory, language, visuospatial abilities, planning, organization, and divided attention. The ECog consists of a global and domain scores for each of the previously described categories, and is scored as follows: 1= better or no change compared to 10 years earlier, 2= questionable/occasionally worse compared to 10 years earlier, 3= consistently a little worse compared to 10 years earlier, 4= consistently much worse compared to 10 years earlier. Thus, the lower the overall score is on this measure at both the global and domain score level, the better one is performing with respect to their cognition.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 41-44 (9-12 weeks post-intervention)
RCI - GAD-7
General Anxiety Disorder-7 ( (GAD-7). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The GAD-7 is a seven-item self-report instrument for screening, diagnosis, and severity assessment of anxiety disorders. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 35-39 (3-6 weeks post-intervention)
RCI - GAD-7
General Anxiety Disorder-7 ( (GAD-7). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The GAD-7 is a seven-item self-report instrument for screening, diagnosis, and severity assessment of anxiety disorders. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 41-44 (9-12 weeks post-intervention)
RCI - NPI-Q
Neuropsychiatric Inventory Questionnaire (NPI-Q). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The neuropsychiatric inventory questionnaire score, which includes 12 items that assesses a broad range of psychiatric disturbances associated with: (1) delusions; (2) hallucinations; (3) agitation or aggression; (4) depression or dysphoria; (5) anxiety; (6) elation or euphoria; (7) apathy or indifference; (8) disinhibition; (9) irritability or lability; (10) motor disturbance; (11) nighttime behaviors; and (12) appetite and eating, is scored by severity (1-3), and distress to caregiver (0-5), then added together (range 0-8) with a higher score indicating greater severity.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96
Measured: Week 35-39 (3-6 weeks post-intervention)]
RCI - NPI-Q
Neuropsychiatric Inventory Questionnaire (NPI-Q). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The neuropsychiatric inventory questionnaire score, which includes 12 items that assesses a broad range of psychiatric disturbances associated with: (1) delusions; (2) hallucinations; (3) agitation or aggression; (4) depression or dysphoria; (5) anxiety; (6) elation or euphoria; (7) apathy or indifference; (8) disinhibition; (9) irritability or lability; (10) motor disturbance; (11) nighttime behaviors; and (12) appetite and eating, is scored by severity (1-3), and distress to caregiver (0-5), then added together (range 0-8) with a higher score indicating greater severity.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96
Measured: Week 41-44 (9-12 weeks post-intervention)
RCI - CGI-S
Clinical Global Impression Severity Scale (CGI-S). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point (1-7) scale that requires the clinician to assess how the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention with the higher scores indicating higher symptom severity.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 35-39 (3-6 weeks post-intervention)
RCI - CGI-S
Clinical Global Impression Severity Scale (CGI-S). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point (1-7) scale that requires the clinician to assess how the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention with the higher scores indicating higher symptom severity.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline. • Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 41-44 (9-12 weeks post-intervention)
RCI - CDR
Global Clinical Dementia Rating (CDR). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Clinical Dementia Rating Global Score (CDR-GS) assesses the overall severity of cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Global scores range from 0 to 3, with higher scores indicating greater impairment.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 35-39 (3-6 weeks post-intervention)
RCI - CDR
Global Clinical Dementia Rating (CDR). Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Clinical Dementia Rating Global Score (CDR-GS) assesses the overall severity of cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Global scores range from 0 to 3, with higher scores indicating greater impairment.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 41-44 (9-12 weeks post-intervention)
RCI - MADRS
Montgomery-Åsberg Depression Rating Scale (MADRS) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to measure the severity of depressive episodes and monitor patient progress during treatment. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60.[4] Higher MADRS score indicates more severe depression. Usual cutoff points are: 0 to 6: normal /symptom absent; 7 to 19: mild depression; 20 to 34: moderate depression 35 to 60: severe depression.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 35-39 (3-6 weeks post-intervention)
RCI - MADRS
Montgomery-Åsberg Depression Rating Scale (MADRS) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to measure the severity of depressive episodes and monitor patient progress during treatment. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60.[4] Higher MADRS score indicates more severe depression. Usual cutoff points are: 0 to 6: normal /symptom absent; 7 to 19: mild depression; 20 to 34: moderate depression 35 to 60: severe depression.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 41-44 (9-12 weeks post-intervention)
RCI - C-SSRS
Columbia-Suicide Severity Rating Scale (C-SSRS) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a brief, evidence-based tool used to screen for suicide risk, measure the severity of suicidal ideation, and track suicidal behavior. Screening versions typically group responses into general clinical risk categories: • No Risk / Score 0: No ideation or behavior reported. • Low Risk (e.g., Categories 1-2): Wish to be dead or non-specific active thoughts. • Moderate Risk (e.g., Category 3 or interrupted/aborted) Method without plan • High Risk (e.g., Categories 4-5, actual attempts, detailed plan): Active intent/plan.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 35-39 (3-6 weeks post-intervention)
RCI - C-SSRS
Columbia-Suicide Severity Rating Scale (C-SSRS) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a brief, evidence-based tool used to screen for suicide risk, measure the severity of suicidal ideation, and track suicidal behavior. Screening versions typically group responses into general clinical risk categories: • No Risk / Score 0: No ideation or behavior reported. • Low Risk (e.g., Categories 1-2): Wish to be dead or non-specific active thoughts. • Moderate Risk (e.g., Category 3 or interrupted/aborted) Method without plan • High Risk (e.g., Categories 4-5, actual attempts, detailed plan): Active intent/plan.
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 41-44 (9-12 weeks post-intervention)
RCI - MoCA
Montreal Cognitive Assessment (MoCA) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Montreal Cognitive Assessment (MoCA) is a quick 30-point test used by health professionals to screen adults for mild memory and thinking problems. MoCA Normal and Mild cognitive impairment score ranges were derived from the JAGS 2005 MoCA Validation study where MoCA MCI score ranges were defined by Petersons' Criteria. The moderate and severe groups were arbitrary defined by default as: Normal Cognitive performance 26 and above; Mild impairment 18-25; Moderate impairment 10-17; Severe impairment 0-9
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 35-39 (3-6 weeks post-intervention)
RCI - MoCA
Montreal Cognitive Assessment (MoCA) Participant's primary memory and cognitive measures Reliable Change Index (RCI) in either direction. The Montreal Cognitive Assessment (MoCA) is a quick 30-point test used by health professionals to screen adults for mild memory and thinking problems. MoCA Normal and Mild cognitive impairment score ranges were derived from the JAGS 2005 MoCA Validation study where MoCA MCI score ranges were defined by Petersons' Criteria. The moderate and severe groups were arbitrary defined by default as: Normal Cognitive performance 26 and above; Mild impairment 18-25; Moderate impairment 10-17; Severe impairment 0-9
- Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline.
- Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
Measured: Week 41-44 (9-12 weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Open-Label Optimization During the first 8 months of the clinical trial, we will program the device and monitor for changes in symptoms in an open-label fashion, with no blinding. All the participants will be evaluated at the end of the open label period (Week 32). DOUBLE-BLIND DISCONTINUATION (Week 33 - Week 45) Both responders and non-responders will enter a double-blind discontinuation period. Total anticipated duration of this portion of the study is up to 12 weeks. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p\<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Lega, University of Texas Southwestern Medical Center
- Investigators
- Bradley Lega, MD, Principal investigator, University of Texas Southwestern Medical CenterBrendan Kelley, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887737
- Sponsor's protocol ID
- STU20260854
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07887737
- Acronym / sponsor ID
- STU20260854
- Conditions
- Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Amnestic, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Memory Deficit, Memory Disorder
- Keywords
- Deep Brain Stimulation, Neuromodulation of Memory, Memory Disorder, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a 12-month safety and feasibility study, enrolling up to six participants. These participants will serve as their own controls, structured in multiple parts that follow an initial short-term stereo electroencephalography (SEEG) mapping period.
During this trial we aim to demonstrate the safety of acute and chronic network-guided stimulation in Mild Cognitive Impairment by evaluating adverse effects, tolerability, and feasibility during both the short- term SEEG mapping phase and subsequent permanent DBS therapy.
In addition to safety measures, therapeutic results as follows are to be tested for: (1) Develop patient-specific stimulation parameters for the treatment of MCI, as well as develop and test memory state classifiers by enrolling six individuals to undergo intracranial mapping (SEEG). We will use targeted memory tasks to generate neural data needed for state distinctions, and conduct a systematic parameter search to identify and develop optimal settings for each patient. (2) Assess efficacy of open loop stimulation by delivering a fixed open loop protocol based on the parameters discovered earlier, while SEEG electrodes remain in place, and testing the efficacy of the trained classifier to detect favorable brain states. (3) Evaluate chronic DBS therapy by implanting a permanent system in participants who show an acute beneficial response to assess long term outcomes. (4) Assess therapeutic outcomes and refine protocols by measuring reductions in memory-related impairment.
The above findings will guide further refinement of the device and protocol.
Detailed description
This is a 12-month, within-subject safety and feasibility study evaluating network-guided deep brain stimulation (DBS) for Mild Cognitive Impairment (MCI), enrolling up to six participants who serve as their own controls. The protocol proceeds through a screening phase, a short-term intracranial mapping period using stereo-electroencephalography (SEEG), permanent DBS implantation, an open-label programming phase, a double-blind discontinuation phase, and long-term follow-up.
Screening and Presurgical Baseline (up to 16 weeks before implantation). Eligible participants undergo a thorough standardized neuropsychological evaluation, including demographic and medical/psychiatric history, physical and mental status exams, vital signs, laboratory testing, and medication review (with specific attention to anti-amyloid monoclonal antibody therapy, which must be paused at least 12 weeks before surgery).
Participants undergo CT and 3T MRI imaging (structural, diffusion tractography, and resting-state functional sequences) for surgical planning. A presurgical baseline visit within 1-4 weeks of surgery repeats key labs, adds cardiac risk assessment (EKG, anesthesiology evaluation), confirms surgical clearance, and administers neuropsychological battery assessing processing speed, working memory, executive function, verbal and visual memory, and language.
SEEG Implantation and Inpatient Mapping (Day 0-7). Using standard stereotactic technique and ROSA planning software, 12 intracranial electrode trajectories (six per hemisphere) are placed targeting the anterior and posterior hippocampus, anterior and posterior cingulate cortex, anterior insula, and orbitofrontal cortex. Electrodes are measured using the NeuroPort recording system (Blackrock Microsystems, FDA-cleared under 510(k) K09095), sampling approximately 160 contacts at 2 kHz. All participants are monitored by the clinical staff, and maintained on antibiotics during admission.
Three experiments are conducted during the inpatient stay:
- Experiment 1 (Brain-state modeling): Participants perform memory tasks (CVLT-III, associative memory, serial recall, spatial navigation) to build patient-specific neural classifiers distinguishing favorable from unfavorable memory-related brain states.
- Experiment 2 (Parameter search): A grid-search paradigm delivers biphasic stimulation across target regions at varying amplitude (1-3 mA) and frequency, held within a fixed safety ceiling (200 µs pulse width, maximum charge density of 30 µC/cm²/phase, well under the Shannon safety criterion). Stimulation effects are evaluated against the classifier to identify parameters that shift brain activity toward a favorable memory state, with continuous epileptologist oversight for after-discharges and cardiopulmonary monitoring throughout.
- Experiment 3 (Open-loop stimulation): Using parameters identified in the search phase, two sessions combine a stimulation-free baseline with alternating active and sham stimulation blocks in a 2×2 design. Verbal memory (HVLT-R) and classifier-based neural biomarkers serve as outcome measures, reflecting the expectation that full therapeutic benefit may require weeks of chronic stimulation.
DBS Implantation (Day 7 ± 3 days). Participants meeting criteria proceed to explant of the SEEG electrodes and implantation of two permanent DBS leads (one per hemisphere, at sites selected from mapping data) along with a subcutaneous pulse generator, performed under general anesthesia with standard perioperative antibiotic prophylaxis. A post-procedure CT confirms absence of complications (e.g. hemorrhage) before discharge.
Postoperative Visits and Device Activation (Day 14 and Day 21). A one-week post-operative visit assesses wound healing and neurological status, with weekly follow-up thereafter for monitoring purposes. Approximately two weeks post-implant, device activation occurs using the rank-ordered parameter sets derived from inpatient testing. Predefined stopping/delay criteria apply (e.g., ≥4-point MoCA worsening confirmed at 48 hours, ≥10-point MADRS increase, or new suicidality), triggering deferral and biweekly reassessment until baseline status is re-established.
Open-Label Phase (Months 1-8). Programming is individualized based on inpatient-derived parameters, with amplitude titrated to balance benefit and side effects. Periodic visits track mood, cognition, and function (GAD-7, MADRS, C-SSRS, MoCA, ECog, CDR, CGI-S, HVLT-R), and the same stopping rules apply if worsening is observed on two consecutive visits, prompting stimulation cessation and supportive care.
Double-Blind Discontinuation (Weeks 33-45). All participants, regardless of open-label response, enter a blinded discontinuation period of up to 12 weeks to further characterize effects.
Long-Term Follow-Up. Participants are followed annually after completion of the blinded discontinuation phase to monitor device safety and intended clinical outcomes.
Across all phases, primary objectives are to characterize the safety, tolerability, and feasibility of acute (SEEG-based) and chronic (DBS) network-guided stimulation in MCI. Secondary objectives include developing patient-specific stimulation parameters and memory-state classifiers, testing open-loop stimulation efficacy, and evaluating longer-term cognitive and functional outcomes to inform refinement of the stimulation protocol and device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Open-Label Optimization During the first 8 months of the clinical trial, we will program the device and monitor for changes in symptoms in an open-label fashion, with no blinding. All the participants will be evaluated at the end of the open label period (Week 32). DOUBLE-BLIND DISCONTINUATION (Week 33 - Week 45) Both responders and non-responders will enter a double-blind discontinuation period. Total anticipated duration of this portion of the study is up to 12 weeks. * Responders are defined as those having a reliable improvement, based on the Reliable Change Index (RCI) of ≥1.96 (p<0.05) on the primary memory and cognitive measures relative to baseline. * Non-responders are defined as those who fail to achieve an RCI of ≥ 1.96.
| Arm | Type | Receives |
|---|---|---|
| Deactivation of Stimulation with the Abbott St Jude Medical Infinity™ | Placebo comparator | Device: Abbott St Jude Medical Infinity™Subjects will be deactivated (stimulation no longer occurs) from stimulation with the Abbott St Jude Medical Infinity™. Weekly assessments on primary memory measures will occur. |
| Stimulation Continuation with Abbott St Jude Medical Infinity™ | Experimental | Device: Abbott St Jude Medical Infinity™Subjects will continue stimulation (stimulation occurs) with the Abbott St Jude Medical Infinity™ based on parameters developed in the inpatient stay. Weekly assessments on primary memory measures will occur. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women (non-pregnant) between ages 60 and 85.
- Meets NIA-AA core clinical criteria for MCI due to Alzheimer's Disease.
- Determination by the investigator, based on clinical judgment and review of medical history, neurological examination, cognitive profile, and available clinical data, that Alzheimer's Disease is the primary suspected etiology.
- Absence of other psychiatric or physical conditions that could interfere with the study.
- Stable medication regimen for 4 weeks preceding surgery; participants currently receiving anti-amyloid therapies may enroll if they are able and willing to pause infusions for at least 12 weeks prior to study initiation and for the duration of the study.
Key exclusion criteria (23 listed)
- Active alcohol or substance use disorder within 6 months of entering the Screening Phase, excluding nicotine. Urine drug test positive for illicit drugs.
- Neurological/Medical condition that makes the participant, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation).
- Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital brain malformation, neuro-developmental disorder , or other factors that predispose seizures such as an active eating disorder).
- Cognitive symptoms that are not be better explained by delirium, unstable psychiatric illness, active substance use disorder, major untreated sleep disorder, acute neurologic illness, or other medical condition that, in the investigator's judgment, is the primary cause of the impairment.
- Brain structural MRI abnormalities outside of expected pathology associated with Mild Cognitive Impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott St Jude Medical Infinity™Subjects will be deactivated (stimulation no longer occurs) from stimulation/ continue stimulation with the Abbott St Jude Medical Infinity™. Weekly assessments on primary memory measures will occur. | Device | Deactivation of Stimulation with the Abbott St Jude Medical Infinity™, Stimulation Continuation with Abbott St Jude Medical Infinity™ |
Primary outcome
Demonstrate device safety
Time frame: 4 years
Description: The primary objective is to demonstrate safety of acute and chronic network guided stimulation for Mild Cognitive Impairment (MCI). This is determined if participants with the Deep Brain Stimulation Device demonstrate no significant device related serious adverse events (SAE). Device safety will be measured by number of reported SAE's in years 2 through 4.
16 secondary outcomes
RCI - ECog
Time frame: Week 35-39 (3-6 weeks post-intervention)
RCI - ECog
Time frame: Week 41-44 (9-12 weeks post-intervention)
RCI - GAD-7
Time frame: Week 35-39 (3-6 weeks post-intervention)
RCI - GAD-7
Time frame: Week 41-44 (9-12 weeks post-intervention)
RCI - NPI-Q
Time frame: Week 35-39 (3-6 weeks post-intervention)]
RCI - NPI-Q
Time frame: Week 41-44 (9-12 weeks post-intervention)
RCI - CGI-S
Time frame: Week 35-39 (3-6 weeks post-intervention)
RCI - CGI-S
Time frame: Week 41-44 (9-12 weeks post-intervention)
RCI - CDR
Time frame: Week 35-39 (3-6 weeks post-intervention)
RCI - CDR
Time frame: Week 41-44 (9-12 weeks post-intervention)
RCI - MADRS
Time frame: Week 35-39 (3-6 weeks post-intervention)
RCI - MADRS
Time frame: Week 41-44 (9-12 weeks post-intervention)
RCI - C-SSRS
Time frame: Week 35-39 (3-6 weeks post-intervention)
RCI - C-SSRS
Time frame: Week 41-44 (9-12 weeks post-intervention)
RCI - MoCA
Time frame: Week 35-39 (3-6 weeks post-intervention)
RCI - MoCA
Time frame: Week 41-44 (9-12 weeks post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment (MCI)
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
RecruitingObservational study
Use of Wearables for Identifying Factors Associated With Mild Cognitive Impairment and Early-Stage Alzheimer's Disease
Mild Cognitive Impairment, Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tash Mupambo, MS contact
Bradley Lega, MD principal investigator
University of Texas Southwestern Medical Center
Brendan Kelley, MD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Abbott St Jude Medical Infinity™ in people with Mild Cognitive Impairment (MCI) and Mild Cognitive Impairment (MCI) Amnestic, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bradley Lega, MD (214-648-7816 ext. 214-648-7816, Bradley.Lega@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate device safety (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.