Parkinson DiseaseNCT06169852
Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
A study testing Unilateral dual-target (STN/GPi) DBS in people with Parkinson Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Our goal is to better understand how DBS modifies local neuronal activity and to pioneer device technologies that can record local DBS-evoked potentials (DLEPs) to guide therapy. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Unilateral dual-target (STN/GPi) DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 30 Nov 2028
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years and older.
- Clinically definite, advanced idiopathic PD based on at least 2 of 3 cardinal PD features (tremor, rigidity, and/or bradykinesia).
- Disease duration of 4 years or more.
- Participant has elected to undergo awake DBS surgery as part of routine care, and the subthalamic nucleus (STN) or globus pallidus interna (GPi) are recommended by the multidisciplinary DBS committee as the surgical target.
- For participants who opt for the dual-target strategy, neurosurgery judges that dual-target STN and GPi implant is an appropriate option with acceptable safety profile.
- Participant is healthy enough to undergo surgery and the research protocol.
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- Normal, or essentially normal, preoperative brain MRI, except for expected mild abnormalities associated with advanced PD.
- Willingness and ability to cooperate during awake DBS surgery, as well as during post-operative evaluations, adjustments of medications and stimulator settings.
- Participant's health insurance and/or Medicare covers DBS surgery as part of routine care.
- Refractory motor symptoms such as dyskinesias, wearing off, and/or motor fluctuations, causing significant disability or occupational dysfunction, despite reasonable attempts at medical management, as determined by our consensus DBS committee.
- Stable doses of PD medications for at least 28 days prior to baseline assessments.
- Improvement of motor signs ≥30% with dopaminergic medication as assessed with the use of the Movement Disorders - Unified Parkinson's Disease Rating Scale, part III (MDS-UPDRS III; scores range from 0 to 108, with higher scores indicating worse functioning). One exception to this 30% threshold is patients who have typical features of PD but cannot take levodopa because of unacceptable side effects.19
- Disease severity ratings above Hoehn and Yahr stage 2.5, defined as unilateral involvement only with minimal or no functional disability, with scores ranging from 0 to 5 and higher scores indicating more severe disease.
- Score of more than 6 for activities of daily living in the worst "off" medication condition despite medical treatment, as assessed with the use of the MDS-UPDRS II (scores range from 0 to 52, with higher scores indicating worse functioning), or mild-to-moderate impairment in social and occupational functioning (score of 51 to 80% on the Social and Occupational Functioning Assessment Scale with scores ranging from 1 to 100 and lower scores indicating worse functioning).
- Dementia Rating Scale-2 (DRS-2) score of ≥130 on medications.
- Beck Depression Inventory II (BDI-II) score of ≤25 on medications.
- No indication of suicidal ideation or active suicidal thoughts as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRC).
- Participant expresses understanding of the consent process, terms of the study protocol, is available for follow-up over the length of the study, and signs informed consent.
Who cannot join
- Age <18 years.
- Participant's insurance will not cover the costs of surgery with an investigational device (Aims 2 and 3 only).
- Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation.
- Duration of disease of <4 years
- Clinical team suspects patient will need staged contralateral DBS for clinical symptoms within 1 year of unilateral DBS surgery.
- Diagnosis or suspicion of atypical parkinsonism (progressive supranuclear palsy, multiple system atrophy, corticobasal syndrome) or drug-induced parkinsonism, or significant neurological disease other than Parkinson's disease.
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- Diagnosis of psychogenic movement disorder based on consensus criteria.
- Dual-target implant cannot be performed safely from a single burr hole because of anatomic constraints or cortical vascular anatomy, based upon the pre-operative neurosurgery plan.
- Patient is undergoing DBS electrode placement under general anesthesia without awake electrophysiological and clinical testing during implant.
- Score of >25 on the Beck Depression Inventory II, with scores ranging from 0 to 63 and higher scores indicating worse functioning), or history of suicide attempt.
- An indication of suicidal ideation or active suicide planning as assessed on the Columbia-Suicide Severity Rating Scale.
- Any current acute psychosis, alcohol abuse or drug abuse.
- Clinical dementia (score of ≤130 on the Mattis Dementia Rating Scale with scores ranging from 0 to 144 and higher scores indicating better functioning).
- Ongoing or pervasive impulse control disorder not resolved by reduction of dopaminergic medications.
- Use of anticoagulant medications that cannot be discontinued during perioperative period.
- History of hemorrhagic stroke.
- Current or future risk of immunocompromise that might increase infection risk.
- History of recurrent of unprovoked seizures.
- Lack of clear levodopa responsiveness.
- The presence of an implanted device (e.g., cochlear implant, pacemaker, neurostimulators), whether turned on or off.
- Prior DBS surgery or ablation within the affected basal ganglion.
- Prior DBS surgery on the opposite side of the brain (Aims 2 and 3 only). This may allow us to study some participants twice (i.e., in Aim 1 or 2-3, and again in Aim 1 if they return for DBS on the opposite side of the brain as part of routine care).
- A condition requiring or likely to require the use of diathermy.
- Structural lesions such as basal ganglionic stroke, tumor, or vascular malformation as etiology of the movement disorder.
- Any medical or psychological problem that would interfere with completing the study protocol, as determined by the research team.
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
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 Alabama at Birmingham
Birmingham, Alabama, 35233
Christopher Gonzalez, 205-975-3732, clgonzalez@uabmc.edu
Harrison Walker, MD
About this study
Our goal is to better understand how DBS modifies local neuronal activity and to pioneer device technologies that can record local DBS-evoked potentials (DLEPs) to guide therapy. Our vision is for a patient's unique electrophysiology to guide both electrode targeting during surgery and programming in clinic, eventually as an integrated component of the implanted pulse generator. Our results will inform directional DBS for PD and serve as a model for translation to other diseases where knowledge on DBS circuit interactions is at an even earlier stage.
Read the detailed description
This study is an exploratory single center double-blind, randomized crossover study of unilateral STN versus GPi versus dual-target STN/GPi DBS for motor symptoms of PD. The dual-target approach will allow unique measures of connectivity between STN and GPi, and within-participant clinical contrasts of single target STN, single target GPi, and combined dual-target stimulation. Longitudinal encounters will measure changes in motor function, non-motor function, and patient reported outcomes versus pre-operative baseline in response to each of these stimulation conditions at 4-month intervals after surgery. These blinded encounters will be followed by an unblinded open-label encounter at 16 months utilizing optimized stimulation parameters. In addition to the clinical crossover design, we will retrospectively investigate the extent to which the spatial maps of local DBS-evoked potentials within and across brain targets predict stimulation sites chosen for clinical therapy at either brain target.
- Conditions
- Parkinson Disease
- Being tested
- Unilateral dual-target (STN/GPi) DBS
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, DBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral dual-target (STN/GPi) DBSDevice
Participants will be randomly assigned either DBS stimulation in the STN alone, GPi alone, or a combination of stimulation in the STN and GPi.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (0-4 months) | Experimental | In this arm we will stimulate from either STN alone, GPi alone, or a combination of both STN and GPi. Receives: Device: Unilateral dual-target (STN/GPi) DBS |
| Arm 2 (4-8 months) | Experimental | In this arm we will stimulate from either STN alone, GPi alone, or a combination of both STN and GPi, whichever was not used in Arm 1. Receives: Device: Unilateral dual-target (STN/GPi) DBS |
| Arm 3 (8-12 months) | Experimental | In this arm we will stimulate from either STN alone, GPi alone, or a combination of both STN and GPi, whichever was not used in Arms 1 and 2. Receives: Device: Unilateral dual-target (STN/GPi) DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the biological origin of brain signals using an external stimulation/recording system during standard of care Deep Brain Stimulation surgery, both awake and under general anesthesia.
The investigator will validate the biological origin of the signals using pairs of DBS pulses and neural refractoriness with an external stimulation/recording system at therapeutically relevant stimulus amplitudes (i.e., inside and outside the therapeutic window).
Measured: At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia).
Test whether directional DBS leads elicit spatiotemporally distinct oscillations in subthalamic nucleus versus globus pallidus interna.
This investigators efforts will yield granular spatial maps of neural engagement across the two canonical targets for PD to guide targeting (awake or under anesthesia) and clinical programming.
Measured: At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia).
Test whether spatial maps of DBS-evoked oscillations predict clinically effective stimulation sites on a directional DBS lead.
The investigator will test whether spatial maps of DBS-evoked neural activity predict clinically effective locations for directional DBS.
Measured: At standard of care DBS surgery (awake), approximately one week later at standard of care battery placement (under general anesthesia), at in a research clinical assessment at 16 months after DBS surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start12 Jan 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- We are investigating unilateral dual-target DBS. The stimulation paradigms utilized include STN DBS alone, GPi DBS alone, and combined STN/GPi DBS.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Harrison Walker, MD, University of Alabama at Birmingham
- Investigators
- Harrison Walker, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169852
- Sponsor's protocol ID
- IRB-300011568
- Other IDs
- UH3NS130202
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All data resulting from this project are available upon messaging, email, or written request through the Data Archive for the BRAIN Initiative (PI Dr. Toga at University of Southern California). Coded research data are collected such as electrophysiological signals, clinical rating scales, neuroimaging data, computational analysis algorithms, and biostatistics workflows. The investigator will curate and share these raw data and algorithms via DABI. All data are coded and password-protected to ensure the privacy of human research participants.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
- ClinicalTrials.gov ID
- NCT06169852
- Acronym / sponsor ID
- IRB-300011568
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, DBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 14 Dec 2023 (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.
Our goal is to better understand how DBS modifies local neuronal activity and to pioneer device technologies that can record local DBS-evoked potentials (DLEPs) to guide therapy. Our vision is for a patient's unique electrophysiology to guide both electrode targeting during surgery and programming in clinic, eventually as an integrated component of the implanted pulse generator. Our results will inform directional DBS for PD and serve as a model for translation to other diseases where knowledge on DBS circuit interactions is at an even earlier stage.
Detailed description
This study is an exploratory single center double-blind, randomized crossover study of unilateral STN versus GPi versus dual-target STN/GPi DBS for motor symptoms of PD. The dual-target approach will allow unique measures of connectivity between STN and GPi, and within-participant clinical contrasts of single target STN, single target GPi, and combined dual-target stimulation. Longitudinal encounters will measure changes in motor function, non-motor function, and patient reported outcomes versus pre-operative baseline in response to each of these stimulation conditions at 4-month intervals after surgery. These blinded encounters will be followed by an unblinded open-label encounter at 16 months utilizing optimized stimulation parameters. In addition to the clinical crossover design, we will retrospectively investigate the extent to which the spatial maps of local DBS-evoked potentials within and across brain targets predict stimulation sites chosen for clinical therapy at either brain target.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- We are investigating unilateral dual-target DBS. The stimulation paradigms utilized include STN DBS alone, GPi DBS alone, and combined STN/GPi DBS.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (0-4 months) | Experimental | Device: Unilateral dual-target (STN/GPi) DBSIn this arm we will stimulate from either STN alone, GPi alone, or a combination of both STN and GPi. |
| Arm 2 (4-8 months) | Experimental | Device: Unilateral dual-target (STN/GPi) DBSIn this arm we will stimulate from either STN alone, GPi alone, or a combination of both STN and GPi, whichever was not used in Arm 1. |
| Arm 3 (8-12 months) | Experimental | Device: Unilateral dual-target (STN/GPi) DBSIn this arm we will stimulate from either STN alone, GPi alone, or a combination of both STN and GPi, whichever was not used in Arms 1 and 2. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age >18 years and older.
- Clinically definite, advanced idiopathic PD based on at least 2 of 3 cardinal PD features (tremor, rigidity, and/or bradykinesia).
- Disease duration of 4 years or more.
- Participant has elected to undergo awake DBS surgery as part of routine care, and the subthalamic nucleus (STN) or globus pallidus interna (GPi) are recommended by the multidisciplinary DBS committee as the surgical target.
- For participants who opt for the dual-target strategy, neurosurgery judges that dual-target STN and GPi implant is an appropriate option with acceptable safety profile.
Key exclusion criteria (26 listed)
- Age <18 years.
- Participant's insurance will not cover the costs of surgery with an investigational device (Aims 2 and 3 only).
- Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation.
- Duration of disease of <4 years
- Clinical team suspects patient will need staged contralateral DBS for clinical symptoms within 1 year of unilateral DBS surgery.
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 |
|---|---|---|
| Unilateral dual-target (STN/GPi) DBSParticipants will be randomly assigned either DBS stimulation in the STN alone, GPi alone, or a combination of stimulation in the STN and GPi. | Device | Arm 1 (0-4 months), Arm 2 (4-8 months), Arm 3 (8-12 months) |
Primary outcome
Validate the biological origin of brain signals using an external stimulation/recording system during standard of care Deep Brain Stimulation surgery, both awake and under general anesthesia.
Time frame: At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia).
The investigator will validate the biological origin of the signals using pairs of DBS pulses and neural refractoriness with an external stimulation/recording system at therapeutically relevant stimulus amplitudes (i.e., inside and outside the therapeutic window).
Test whether directional DBS leads elicit spatiotemporally distinct oscillations in subthalamic nucleus versus globus pallidus interna.
Time frame: At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia).
This investigators efforts will yield granular spatial maps of neural engagement across the two canonical targets for PD to guide targeting (awake or under anesthesia) and clinical programming.
Test whether spatial maps of DBS-evoked oscillations predict clinically effective stimulation sites on a directional DBS lead.
Time frame: At standard of care DBS surgery (awake), approximately one week later at standard of care battery placement (under general anesthesia), at in a research clinical assessment at 16 months after DBS surgery.
The investigator will test whether spatial maps of DBS-evoked neural activity predict clinically effective locations for directional DBS.
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 20 Oct 2026.
- Individual participant dataSharing planned: Yes. All data resulting from this project are available upon messaging, email, or written request through the Data Archive for the BRAIN Initiative (PI Dr. Toga at University of Southern California). Coded research data are collected such as electrophysiological signals, clinical rating scales, neuroimaging data, computational analysis algorithms, and biostatistics workflows. The investigator will curate and share these raw data and algorithms via DABI. All data are coded and password-protected to ensure the privacy of human research participants.
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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.
Harrison Walker, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral dual-target (STN/GPi) DBS in people with Parkinson Disease, run by University of Alabama at Birmingham 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 18 inclusion and 26 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 20 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 Harrison Walker, MD (205-934-0683, hcwalker@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the biological origin of brain signals using an external stimulation/recording system during standard of care Deep Brain Stimulation surgery, both awake and under general anesthesia. (time frame: At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia).). The study lists 3 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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.