Obsessive-Compulsive DisorderNCT06660225
Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder
A study testing Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation] in people with Obsessive-Compulsive Disorder, run by Nader Pouratian at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer are: Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)stimulation on obsessive/compulsive symptoms. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jan 2031
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria
- Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 27
- Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment.
- Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time period.
- Having failed to improve despite adequate cognitive behavioral therapy, as evaluated by the study psychiatrist
- Patients between 22 and 75.
- Ability to understand and sign written informed consent by the patient.
Who cannot join
- Diagnosis of severe major depression disorder (MDD) with psychotic features.
- Significant suicidal risk [Hamilton Depression scale item 3 (suicide)>2].
- Comorbidity with any primary Psychotic Disorder, Post-Traumatic Stress Disorder (PTSD), or Eating Disorder.
- History of substance or alcohol dependence or abuse in the preceding 12 months.
- Significant cognitive decline, measured by Mini-Mental State Examination (MMSE <26) and Montreal Cognitive Assessment (MoCA; <24).
- Any other current clinical significant neurological disorder or medical illness affecting brain function, other than a tic disorder.
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- Any clinically significant abnormality on preoperative MRI that would affect the safety of the surgical procedure in the opinion of the study neurosurgeon.
- Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Nader Pouratian, M.D., Ph.D., 310-274-2095, Nader.Pouratian@UTSouthwestern.edu
Kala Bailey, M.D.
About this study
Official title: Towards Closed Loop Deep Brain Stimulation for Treatment of Refractory Obsessive-Compulsive Disorder
The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer are:
- Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)stimulation on obsessive/compulsive symptoms.
- Map the amSTN using neuronal responses [single unit and local field potentials (LFP) recordings] at rest and under high frequency stimulation during surgery.
- Record chronic brain activity with the implanted pulse generator and look for neuronal signatures correlated with symptom severity.
Read more
Researchers will compare active deep brain stimulation to a placebo (sham stimulation) to see if DBS works to treat refractory OCD.
Participants will:
- Undergo surgery for the implantation of a deep brain stimulation device
- Follow-up visits every three weeks with study staff
- 6 month follow-up for the next 2-3 years after first year of study participation is complete
Read the detailed description
The primary goal of this research study is to conduct a small scale randomized, double-blind clinical cross-over trial of deep brain stimulation for obsessive-compulsive disorder targeting the anteromedial subthalamic nucleus (amSTN), with which study team will not only produce high quality data of the clinical efficacy of DBS for OCD, but also attain critical insights into the neurophysiological underpinnings of disease and symptoms in OCD. This work will support future innovative therapy development, including refinement of surgical targeting and optimization of therapeutic stimulation.
This will be a 3-year study with the aim of implanting 10 patients with bilateral amSTN DBS leads. Intra-operatively, precise single neuron recordings will be obtained at the therapeutic target while the patient participates symptom provocation. Participants will be implanted with a sensing pulse generator (Medtronic Percept) which enables chronic recordings from the amSTN target in addition to providing therapeutic stimulation. Each participant will be randomized to start with either a sham control stimulation phase or therapeutic stimulation, and cross-over at 4 months. If symptoms recur upon cross-over from therapeutic to sham stimulation, participants will exit the sham stimulation phase and rescue therapy/stimulation will be delivered. All participants will transition to an open label stimulation phase for chronic therapy. Multiple assessments of the participants will follow, including OCD severity, cognition, behavior, and side effects.
Formal psychiatric assessments will take place at two weeks, at one month, and then once every three weeks during the randomization blinded period and then every 6 weeks during the open label period. During psychiatric assessments, the PERCEPT device will be used to obtain neural recordings of the STN activity.
Additionally, for the secondary outcome measure for the association between amSTN activity and cognitive/emotional measure there are two components of this measure that are of a qualitative nature. Burstiness and coherence are unitless measures and thus will not be included in the outcome measure reporting section. They will instead be discussed in the limitation section at annual reporting.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation], Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]
- Keywords
- Obsessive, Compulsive, Deep Brain Stimulation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]Device
Deep brain stimulation is a surgery where bilateral electrodes are precisely inserted to specific brain targets affected by a disease state, and electrical stimulation is applied to achieve symptom relief. DBS is a reversible and adjustable treatment option and is now a preferred alternative to neurosurgical ablation. Sham Stimulation=DBS OFF
Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]Device
Deep brain stimulation is a surgery where bilateral electrodes are precisely inserted to specific brain targets affected by a disease state, and electrical stimulation is applied to achieve symptom relief. DBS is a reversible and adjustable treatment option and is now a preferred alternative to neurosurgical ablation. Therapeutic Stimulation= DBS ON
| Study group | Role | What they receive |
|---|---|---|
| Sham Control stimulation, then Therapeutic stimulation | Experimental | Subject randomized to this arm are initially "OFF" DBS (Deep Brain Stimulation) prior to the open label period for 16 weeks and then "ON" DBS for the next 16 weeks. This is then followed by an open-label period of DBS stimulation. Receives: Device: Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]; Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation] |
| Therapeutic stimulation, then Sham Control stimulation | Experimental | Subjects randomized to this arm are initially "ON" DBS prior to the open label period for 16 weeks and then "OFF" DBS for the next 16 weeks. This is followed by an open-label stimulation period. Receives: Device: Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]; Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation] |
| Therapeutic stimulation | Experimental | All participants will transition to an open label stimulation phase for chronic therapy after the cross-over portion of this trial Receives: Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of amSTN stimulation on OCD symptoms as measured by YBOCS
Assessment of the efficacy of amSTN stimulation on OCD symptoms. This will be assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS). Possible scores range from 0-5 where lower scores indicate better outcome.
Measured: 36 months
Incidence of Adverse events
Safety will be assessed with cumulative serious adverse event rate that will be Frequency at which AEs occur that are directly related to the study device.
Measured: 36 months
Secondary outcomes (9)
Effect of DBS on Mood and Quality of Life as measured by HAM-A survey
Hamilton Scale for Anxiety. A rating scale developed to measure the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and semantic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score ranger of 0-56, where 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: 36 months
Effect of DBS on Mood and Quality of Life as measured by HAM-D21 survey
Hamilton Depression Rating Scale (HAM-D). A 21-item version of the HAM-D that includes 4 items intended to subtype the depression. The HAM-D is originally a 17 item questionnaire pertaining to symptoms of depression experienced over the past week. The patients score is determined using the first 17 questions. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial. Scoring on each question varies.
Measured: 36 months
Effect of DBS on Mood and Quality of Life as measured by BPRS survey
Brief Psychiatric Rating Scale (BPRS). An assessment that assesses the level of the following symptoms; somatic concern, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement, disorientation. Items are scored on a 1(not present) to 7 (extremely severe) scale. It is based on the clinicians interview with the patients and observations of the patient behavior over the previous 2-3 days.
Measured: 36 months
Effect of DBS on Mood and Quality of Life as measured by CGI-S survey
Clinical Global Inventory- Severity scale is used to measure this outcome (CGI-S). This is a 3-item observer-rated scale that measures illness severity (CGI-S). The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through 7 (amongst the most severely ill patients).
Measured: 36 months
Effect of DBS on Mood and Quality of Life as measured by MMSE tool
Mini-Mental State Examination (MMSE). A questionnaire comprised of 11 questions that is used by doctors and other health professionals to check for cognitive impairment. It is typically used to see if you have problems with ones thinking or communication. It can check for problems with understanding and amnesia. The MMSE checks 6 areas of mental ability including; knowing when one is (date and place), attention and concentration, short-term memory (recall), language skills, visual and spatial relationship between objects, ability to understand and follow instructions. The assessment is scored out of 30. A score of 25 or higher is normal, and score below 24 could indicate cognitive impairment.
Measured: 36 months
Association between amSTN activity and cognitive/emotional measures as measured by rate of neural activity
The rate of neural activity will be measured via Hz.
Measured: 36 months
Association between amSTN activity and cognitive/emotional measures as measured by amplitude of neural activity
Amplitude of neural activity will be measured via microamps.
Measured: 36 months
Association between amSTN activity and cognitive/emotional measures as measured by phase
A unit of measurement used to quantify the relationship between the temporal structures of signals in the brain, and are often used to study functional connectivity in neuroscience. This outcome measure will be measured in units of 0-2π.
Measured: 36 months
Association between amSTN activity and cognitive/emotional measures as measured by cross-frequency coupling of neural activity.
Cross-frequency coupling (CFC) is a neuroscience measure that describes the statistical relationship between the frequency, amplitude, or phase of two different frequency bands in the brain. Its a type of neural oscillatory coupling that is been studied in the context of brain health and disease. This data point will be measured via the modulation index.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study startNov 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies 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
- There will be two 4 month blocks in which, depending on group assignment, participants will receive either active or sham stimulation from the DBS device. Following completing of the first 4 month block, the groups will cross-over. Individuals originally receiving active stimulation will now receive sham, and individuals receiving sham stimulation originally will now receive active stimulation. Following the completing of both four month blocks, all participants will receive active open-label treatment. Continued follow-up psychiatric assessments will be preformed every two week during the double-blind portion of the trial, and then every 6 weeks during the open-label treatment phase.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nader Pouratian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nader Pouratian, University of Texas Southwestern Medical Center
- Investigators
- Nader Pouratian, M.D., Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660225
- Sponsor's protocol ID
- STU-2024-0733
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Investigators with established research programs will be eligible for data sharing. Interested investigators will be required to submit a summary of proposed work and requested data elements. If approved by the Principal Investigator of the study, data will be shared. This data will be de-identified and coded. There is no plan to share identifiers outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Closed Loop Deep Brain Stimulation for Treatment of Refractory Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT06660225
- Acronym / sponsor ID
- STU-2024-0733
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive, Compulsive, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nader PouratianUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 28 Oct 2024 (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.
The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer are:
- Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)stimulation on obsessive/compulsive symptoms.
- Map the amSTN using neuronal responses [single unit and local field potentials (LFP) recordings] at rest and under high frequency stimulation during surgery.
- Record chronic brain activity with the implanted pulse generator and look for neuronal signatures correlated with symptom severity.
Researchers will compare active deep brain stimulation to a placebo (sham stimulation) to see if DBS works to treat refractory OCD.
Participants will:
- Undergo surgery for the implantation of a deep brain stimulation device
- Follow-up visits every three weeks with study staff
- 6 month follow-up for the next 2-3 years after first year of study participation is complete
Detailed description
The primary goal of this research study is to conduct a small scale randomized, double-blind clinical cross-over trial of deep brain stimulation for obsessive-compulsive disorder targeting the anteromedial subthalamic nucleus (amSTN), with which study team will not only produce high quality data of the clinical efficacy of DBS for OCD, but also attain critical insights into the neurophysiological underpinnings of disease and symptoms in OCD. This work will support future innovative therapy development, including refinement of surgical targeting and optimization of therapeutic stimulation.
This will be a 3-year study with the aim of implanting 10 patients with bilateral amSTN DBS leads. Intra-operatively, precise single neuron recordings will be obtained at the therapeutic target while the patient participates symptom provocation. Participants will be implanted with a sensing pulse generator (Medtronic Percept) which enables chronic recordings from the amSTN target in addition to providing therapeutic stimulation. Each participant will be randomized to start with either a sham control stimulation phase or therapeutic stimulation, and cross-over at 4 months. If symptoms recur upon cross-over from therapeutic to sham stimulation, participants will exit the sham stimulation phase and rescue therapy/stimulation will be delivered. All participants will transition to an open label stimulation phase for chronic therapy. Multiple assessments of the participants will follow, including OCD severity, cognition, behavior, and side effects.
Formal psychiatric assessments will take place at two weeks, at one month, and then once every three weeks during the randomization blinded period and then every 6 weeks during the open label period. During psychiatric assessments, the PERCEPT device will be used to obtain neural recordings of the STN activity.
Additionally, for the secondary outcome measure for the association between amSTN activity and cognitive/emotional measure there are two components of this measure that are of a qualitative nature. Burstiness and coherence are unitless measures and thus will not be included in the outcome measure reporting section. They will instead be discussed in the limitation section at annual reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- There will be two 4 month blocks in which, depending on group assignment, participants will receive either active or sham stimulation from the DBS device. Following completing of the first 4 month block, the groups will cross-over. Individuals originally receiving active stimulation will now receive sham, and individuals receiving sham stimulation originally will now receive active stimulation. Following the completing of both four month blocks, all participants will receive active open-label treatment. Continued follow-up psychiatric assessments will be preformed every two week during the double-blind portion of the trial, and then every 6 weeks during the open-label treatment phase.
| Arm | Type | Receives |
|---|---|---|
| Sham Control stimulation, then Therapeutic stimulation | Experimental | Device: Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation], Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]Subject randomized to this arm are initially "OFF" DBS (Deep Brain Stimulation) prior to the open label period for 16 weeks and then "ON" DBS for the next 16 weeks. This is then followed by an open-label period of DBS stimulation. |
| Therapeutic stimulation, then Sham Control stimulation | Experimental | Device: Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation], Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]Subjects randomized to this arm are initially "ON" DBS prior to the open label period for 16 weeks and then "OFF" DBS for the next 16 weeks. This is followed by an open-label stimulation period. |
| Therapeutic stimulation | Experimental | Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]All participants will transition to an open label stimulation phase for chronic therapy after the cross-over portion of this trial |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria
- Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 27
- Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment.
- Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time period.
- Having failed to improve despite adequate cognitive behavioral therapy, as evaluated by the study psychiatrist
Key exclusion criteria (9 listed)
- Diagnosis of severe major depression disorder (MDD) with psychotic features.
- Significant suicidal risk [Hamilton Depression scale item 3 (suicide)>2].
- Comorbidity with any primary Psychotic Disorder, Post-Traumatic Stress Disorder (PTSD), or Eating Disorder.
- History of substance or alcohol dependence or abuse in the preceding 12 months.
- Significant cognitive decline, measured by Mini-Mental State Examination (MMSE <26) and Montreal Cognitive Assessment (MoCA; <24).
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 |
|---|---|---|
| Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]Deep brain stimulation is a surgery where bilateral electrodes are precisely inserted to specific brain targets affected by a disease state, and electrical stimulation is applied to achieve symptom relief. DBS is a reversible and adjustable treatment option and is now a preferred alternative to neurosurgical ablation. Sham Stimulation=DBS OFF | Device | Sham Control stimulation, then Therapeutic stimulation, Therapeutic stimulation, then Sham Control stimulation |
| Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]Deep brain stimulation is a surgery where bilateral electrodes are precisely inserted to specific brain targets affected by a disease state, and electrical stimulation is applied to achieve symptom relief. DBS is a reversible and adjustable treatment option and is now a preferred alternative to neurosurgical ablation. Therapeutic Stimulation= DBS ON | Device | Sham Control stimulation, then Therapeutic stimulation, Therapeutic stimulation, Therapeutic stimulation, then Sham Control stimulation |
Primary outcome
Efficacy of amSTN stimulation on OCD symptoms as measured by YBOCS
Time frame: 36 months
Assessment of the efficacy of amSTN stimulation on OCD symptoms. This will be assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS). Possible scores range from 0-5 where lower scores indicate better outcome.
Incidence of Adverse events
Time frame: 36 months
Safety will be assessed with cumulative serious adverse event rate that will be Frequency at which AEs occur that are directly related to the study device.
9 secondary outcomes
Effect of DBS on Mood and Quality of Life as measured by HAM-A survey
Time frame: 36 months
Effect of DBS on Mood and Quality of Life as measured by HAM-D21 survey
Time frame: 36 months
Effect of DBS on Mood and Quality of Life as measured by BPRS survey
Time frame: 36 months
Effect of DBS on Mood and Quality of Life as measured by CGI-S survey
Time frame: 36 months
Effect of DBS on Mood and Quality of Life as measured by MMSE tool
Time frame: 36 months
Association between amSTN activity and cognitive/emotional measures as measured by rate of neural activity
Time frame: 36 months
Association between amSTN activity and cognitive/emotional measures as measured by amplitude of neural activity
Time frame: 36 months
Association between amSTN activity and cognitive/emotional measures as measured by phase
Time frame: 36 months
Association between amSTN activity and cognitive/emotional measures as measured by cross-frequency coupling of neural activity.
Time frame: 36 months
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 1 Oct 2026.
- Individual participant dataSharing planned: No. Investigators with established research programs will be eligible for data sharing. Interested investigators will be required to submit a summary of proposed work and requested data elements. If approved by the Principal Investigator of the study, data will be shared. This data will be de-identified and coded. There is no plan to share identifiers outside the study team.
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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.
Nader Pouratian, M.D., Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation] in people with Obsessive-Compulsive Disorder, run by Nader Pouratian at 1 site in United States.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Nader Pouratian, M.D., Ph.D. (2146486630, Nader.Pouratian@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of amSTN stimulation on OCD symptoms as measured by YBOCS (time frame: 36 months). The study lists 2 primary outcomes in all. 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 1 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.