PD - Parkinson's DiseaseSubgaleal aDBSNCT07398157
Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease
A study testing Medtronic Percept Deep Brain Stimulation (cDBS), Medtronic Percept Deep Brain Stimulation (daytime aDBS) and Medtronic Percept Deep Brain Stimulation (nighttime aDBS) in people with PD - Parkinson's Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to test a new way to treat Parkinson's disease (PD). Subjects will be implanted with deep brain stimulator (DBS) devices and electrodes placed under the scalp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PD - Parkinson's Disease
- What is being tested?
- Medtronic Percept Deep Brain Stimulation (cDBS), Medtronic Percept Deep Brain Stimulation (daytime aDBS) and Medtronic Percept Deep Brain Stimulation (nighttime aDBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-75.
- Diagnosis of idiopathic PD.
- Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe).
- Patient has requested surgical intervention with deep brain stimulation for their disorder or previous enrollment in sponsored IDE (G220241) to use Percept PC wired to subgaleal sensing, if patients have ongoing daytime fluctuations or sleep dysfunction despite cDBS optimization.
- Normal preoperative brain MRI.
- Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA).
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- Signed informed consent.
- Motor UPDRS-III off medication score 25 to 65 and a >35% improvement with levodopa, predominant rigid/bradykinetic symptoms (ratio of off-medication UPDRS-III limb rigidity/bradykinesia scores to limb tremor scores of >1.2).
- Motor fluctuations despite optimized medical therapy with at least 2 hours per day of either "off" time, or "on" with dyskinesias.
- Ability to comply with study follow-up visits for brain recording, testing of closed-loop stimulation, and clinical assessment.
Who cannot join
- Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications.
- Patient meets criteria for a psychogenic movement disorder.
- Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
- Significant untreated depression (BDI-II score >20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).
- Any personality or mood symptoms that study personnel believe will interfere with study requirements.
- Patient who requires electroconvulsive therapy, repetitive transcranial magnetic stimulation, or diathermy, implanted neurostimulators and MR-incompatible metallic implants, previous craniotomy on the side of the intended subgaleal implant, and drug or alcohol abuse.
- Patients who experience adverse effects that are undesirable and detrimental to the health of subjects from DBS or other similar neurostimulators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Manager contact
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Sebastian Liu, 5175152739, sebastian.liu@ucsf.edu
About this study
Official title: Subgaleal Cortical Electrodes in Patients With Parkinson's Disease Undergoing Deep-brain Stimulation Therapy for Sensing and Adaptive Deep-brain Stimulation Over a 24-hour Period.
The purpose of this study is to test a new way to treat Parkinson's disease (PD). Subjects will be implanted with deep brain stimulator (DBS) devices and electrodes placed under the scalp.
The main questions it aims to answer are:
- Is there a less invasive method to collect useful brain signals? Find out if these brain signals can be related to movement and/or sleep symptoms.
- How to use these brain signals to tailor adaptive deep brain stimulation settings for movement and/or sleep symptoms
Researchers will compare study derived adaptive DBS settings to subject's clinically programmed continuous DBS settings to see which is better at treating patients PD symptoms.
Read the detailed description
Parkinson's disease (PD) affects 1% of people over 60 years old, is highly disabling and represents a large economic burden. Therapeutic options include dopaminergic replacement and conventional DBS (cDBS) for advanced disease. However, cDBS therapy is currently unresponsive to the dynamic clinical states of patients, resulting in suboptimal control of symptoms during the day. Adaptive DBS (aDBS) seeks to solve this through personalized dynamic modulation of stimulation according to neural signals. Early studies of aDBS (completed by Drs Little, Starr and other research groups) provide proof-of-principle that aDBS can improve motor symptoms and reduce side-effects. Our team has also tested fully embedded, chronic naturalistic aDBS in a randomized, blinded study to show improvements in daytime motor symptoms and quality of life compared to cDBS. Further, the investigators have also recently validated sleep stage specific Non Rapid Eye Movement (NREM) aDBS, that increased cortical slow waves (linked to slowed disease progression). However, full leveraging of these highly promising therapies is currently limited by: 1) Lack of practical (minimally invasive) methods for chronic cortical recordings. 2) Complexity of programming aDBS due to a large parameter space. 3) Fluctuations in neural signals on multiple time scales, including circadian changes and long-term non-stationarity of signals. Our long-term goal is to advance aDBS from specialist research laboratories to real-world clinics through efficient, scalable implementation with the following advances: 1) Reduce risk and complexity of chronic cortical sensing by placing cortical leads in the subgaleal space rather than inside the cranium. 2) Utilize machine learning (ML) and data-driven biomarker and optimization techniques to minimize aDBS programming complexity. 3) Optimize aDBS across the full 24hr cycle - including sleep, with methods for long-term updating of aDBS settings. The study device will be the rechargeable, sensing and aDBS enabled, newly commercially available Medtronic Percept RC DBS system; connected to subgaleal frontal cortex leads and to directional basal ganglia leads. Our UG3 stage will support regulatory approval for Percept RC subgaleal aDBS. In UH3-
1, the investigators will implant 24 PD patients, optimize cDBS, and identify subgroups for daytime and nighttime aDBS. In UH3-2 the investigators will obtain in-clinic and at-home daytime naturalistic neural recordings and perform a blinded evaluation of data-driven chronic aDBS versus cDBS, for treatment of daytime motor fluctuations. In UH3-3, the investigators will obtain in-clinic (sleep lab) and at-home nighttime naturalistic recordings and perform a blinded evaluation of chronic sleep aDBS versus cDBS, to improve NREM sleep duration and increase slow wave amplitude. The investigators anticipate that these techniques will be the basis for a simple "turnkey" aDBS controller, to enable widespread, simple, scaleable and personalized aDBS for the full 24 hr cycle in PD, and provide a rational foundation for adaptive neuromodulation in other neurological and psychiatric diseases.
- Conditions
- PD - Parkinson's Disease
- Being tested
- Medtronic Percept Deep Brain Stimulation (cDBS), Medtronic Percept Deep Brain Stimulation (daytime aDBS), Medtronic Percept Deep Brain Stimulation (nighttime aDBS)
- Keywords
- Subgaleal, adaptive, 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.
Medtronic Percept Deep Brain Stimulation (cDBS)Device
Also called deep brain stimulation, DBS, cDBS, continuous DBS
Using the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus.
Medtronic Percept Deep Brain Stimulation (daytime aDBS)Device
Also called aDBS, adaptive DBS, adaptive deep brain stimulation
Using the Percept pulse generator, patients receive daytime adaptive stimulation to the subthalmaic nucleus.
Medtronic Percept Deep Brain Stimulation (nighttime aDBS)Device
Also called aDBS, adaptive DBS, adaptive deep brain stimulation
Using the Percept pulse generator, patients receive nighttime adaptive stimulation to the subthalmaic nucleus.
| Study group | Role | What they receive |
|---|---|---|
| Nighttime adaptive DBS programming | Experimental | The patient will undergo at-home blinded testing of the single power band N2/3 sleep stage aDBS (e.g 75% \& 125% conditions, levels chosen for each subject by the clinician or by the study team using data analysis) versus cDBS. Initially the patient will complete ~2 months (60 nights) of randomized, blinded, single night trials of aDBS at lower amplitude (e.g. 75%; 20 nights), aDBS at higher amplitude (e.g. 125% 20 nights) versus cDBS 100% (20 nights) to detect efficacy at the single subject level in independent N-of-1 trials. Stimulation amplitudes will be personalized and selected for tolerability and by searching for amplitudes that impact sleep physiology during the setup phase. Formal final testing will be completed in randomized, counterbalanced condition blocks. Patients will be in cDBS mode during the daytime and will perform a blinded switch to either cDBS or aDBS in the evening before going to sleep (or using the scheduling app). Receives: Device: Medtronic Percept Deep Brain Stimulation (cDBS); Device: Medtronic Percept Deep Brain Stimulation (nighttime aDBS) |
| Daytime adaptive DBS Programming | Experimental | Investigators will conduct a blinded, randomized comparison between the effects of aDBS and clinically optimized cDBS on motor signs and symptoms. Both stimulation conditions will be applied for 1 day, in blocks of 2 days that are randomized and counterbalanced for over 40 days in patients' homes. Patients will be in cDBS mode overnight and will perform a blinded switch to either cDBS or aDBS in the morning on waking (these will appear to the patient as programs C and D). Investigators will utilize patients' daily symptom diaries and wearable data. They will ask patients to complete the symptom diary (an electronic questionnaire) every night before bedtime. This focuses on the total number of hours spent with symptoms, severity, and a quality of life (QoL) score validated for daily assessment of health-related QoL (EQ-5D). Evaluated symptoms include the most bothersome and opposite symptom as well as a range of common motor symptoms including bradykinesia, dyskinesia, tremor, etc... Receives: Device: Medtronic Percept Deep Brain Stimulation (cDBS); Device: Medtronic Percept Deep Brain Stimulation (daytime aDBS) |
| Open-loop continuous deep brain stimulation | Active comparator | Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation. Receives: Device: Medtronic Percept Deep Brain Stimulation (cDBS); Device: Medtronic Percept Deep Brain Stimulation (daytime aDBS); Device: Medtronic Percept Deep Brain Stimulation (nighttime aDBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of bothersome movement and/or sleep episodes on adaptive deep brain stimulation compared to open-loop deep brain stimulation
Troublesome movement and/or sleep episodes will be detected using validated home wearable devices along with participant self-reporting.
Measured: Baseline, aDBS testing, and during Blinded Assessment
Secondary outcomes (2)
Change in MDS-UPDRS III scores
Change in Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) III score. The scale consists of 18 items that are each scored 0 to 3, making the total score out of 72 points, with higher scores indicating higher impairment.
Measured: Baseline, aDBS testing, and Blinded Assessment
Change in Total Electrical Energy Delivered (TEED)
Change in TEED calculated using voltage, frequency, pulse width, and impedence values from participant pulse generators, with adaptive compared to open-loop deep brain stimulation (DBS). TEED is measured in microjoules.
Measured: Baseline, aDBS testing, and Blinded Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start9 Apr 2026
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD - Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon J. Little, MBBS, PhD, University of California, San Francisco
- Investigators
- Simon Little, Principal investigator, University of California, San FranciscoPhilip Starr, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398157
- Sponsor's protocol ID
- 25-45027
- Other IDs
- 1UG3NS140730-01
- Acronym
- Subgaleal aDBS
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2026
- Last updated
- 14 Sep 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subgaleal Cortical Electrodes in Patients With Parkinson's Disease Undergoing Deep-brain Stimulation Therapy for Sensing and Adaptive Deep-brain Stimulation Over a 24-hour Period.
- ClinicalTrials.gov ID
- NCT07398157
- Acronym / sponsor ID
- Subgaleal aDBS / 25-45027
- Conditions
- PD - Parkinson's Disease
- Keywords
- Subgaleal, adaptive, DBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 9 Feb 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.
The purpose of this study is to test a new way to treat Parkinson's disease (PD). Subjects will be implanted with deep brain stimulator (DBS) devices and electrodes placed under the scalp.
The main questions it aims to answer are:
- Is there a less invasive method to collect useful brain signals? Find out if these brain signals can be related to movement and/or sleep symptoms.
- How to use these brain signals to tailor adaptive deep brain stimulation settings for movement and/or sleep symptoms
Researchers will compare study derived adaptive DBS settings to subject's clinically programmed continuous DBS settings to see which is better at treating patients PD symptoms.
Detailed description
Parkinson's disease (PD) affects 1% of people over 60 years old, is highly disabling and represents a large economic burden. Therapeutic options include dopaminergic replacement and conventional DBS (cDBS) for advanced disease. However, cDBS therapy is currently unresponsive to the dynamic clinical states of patients, resulting in suboptimal control of symptoms during the day. Adaptive DBS (aDBS) seeks to solve this through personalized dynamic modulation of stimulation according to neural signals. Early studies of aDBS (completed by Drs Little, Starr and other research groups) provide proof-of-principle that aDBS can improve motor symptoms and reduce side-effects. Our team has also tested fully embedded, chronic naturalistic aDBS in a randomized, blinded study to show improvements in daytime motor symptoms and quality of life compared to cDBS. Further, the investigators have also recently validated sleep stage specific Non Rapid Eye Movement (NREM) aDBS, that increased cortical slow waves (linked to slowed disease progression). However, full leveraging of these highly promising therapies is currently limited by: 1) Lack of practical (minimally invasive) methods for chronic cortical recordings. 2) Complexity of programming aDBS due to a large parameter space. 3) Fluctuations in neural signals on multiple time scales, including circadian changes and long-term non-stationarity of signals. Our long-term goal is to advance aDBS from specialist research laboratories to real-world clinics through efficient, scalable implementation with the following advances: 1) Reduce risk and complexity of chronic cortical sensing by placing cortical leads in the subgaleal space rather than inside the cranium. 2) Utilize machine learning (ML) and data-driven biomarker and optimization techniques to minimize aDBS programming complexity. 3) Optimize aDBS across the full 24hr cycle - including sleep, with methods for long-term updating of aDBS settings. The study device will be the rechargeable, sensing and aDBS enabled, newly commercially available Medtronic Percept RC DBS system; connected to subgaleal frontal cortex leads and to directional basal ganglia leads. Our UG3 stage will support regulatory approval for Percept RC subgaleal aDBS. In UH3-
1, the investigators will implant 24 PD patients, optimize cDBS, and identify subgroups for daytime and nighttime aDBS. In UH3-2 the investigators will obtain in-clinic and at-home daytime naturalistic neural recordings and perform a blinded evaluation of data-driven chronic aDBS versus cDBS, for treatment of daytime motor fluctuations. In UH3-3, the investigators will obtain in-clinic (sleep lab) and at-home nighttime naturalistic recordings and perform a blinded evaluation of chronic sleep aDBS versus cDBS, to improve NREM sleep duration and increase slow wave amplitude. The investigators anticipate that these techniques will be the basis for a simple "turnkey" aDBS controller, to enable widespread, simple, scaleable and personalized aDBS for the full 24 hr cycle in PD, and provide a rational foundation for adaptive neuromodulation in other neurological and psychiatric diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nighttime adaptive DBS programming | Experimental | Device: Medtronic Percept Deep Brain Stimulation (cDBS), Device: Medtronic Percept Deep Brain Stimulation (nighttime aDBS)The patient will undergo at-home blinded testing of the single power band N2/3 sleep stage aDBS (e.g 75% \& 125% conditions, levels chosen for each subject by the clinician or by the study team using data analysis) versus cDBS. Initially the patient will complete ~2 months (60 nights) of randomized, blinded, single night trials of aDBS at lower amplitude (e.g. 75%; 20 nights), aDBS at higher amplitude (e.g. 125% 20 nights) versus cDBS 100% (20 nights) to detect efficacy at the single subject level in independent N-of-1 trials. Stimulation amplitudes will be personalized and selected for tolerability and by searching for amplitudes that impact sleep physiology during the setup phase. Formal final testing will be completed in randomized, counterbalanced condition blocks. Patients will be in cDBS mode during the daytime and will perform a blinded switch to either cDBS or aDBS in the evening before going to sleep (or using the scheduling app). |
| Daytime adaptive DBS Programming | Experimental | Device: Medtronic Percept Deep Brain Stimulation (cDBS), Device: Medtronic Percept Deep Brain Stimulation (daytime aDBS)Investigators will conduct a blinded, randomized comparison between the effects of aDBS and clinically optimized cDBS on motor signs and symptoms. Both stimulation conditions will be applied for 1 day, in blocks of 2 days that are randomized and counterbalanced for over 40 days in patients' homes. Patients will be in cDBS mode overnight and will perform a blinded switch to either cDBS or aDBS in the morning on waking (these will appear to the patient as programs C and D). Investigators will utilize patients' daily symptom diaries and wearable data. They will ask patients to complete the symptom diary (an electronic questionnaire) every night before bedtime. This focuses on the total number of hours spent with symptoms, severity, and a quality of life (QoL) score validated for daily assessment of health-related QoL (EQ-5D). Evaluated symptoms include the most bothersome and opposite symptom as well as a range of common motor symptoms including bradykinesia, dyskinesia, tremor, etc... |
| Open-loop continuous deep brain stimulation | Active comparator | Device: Medtronic Percept Deep Brain Stimulation (cDBS), Device: Medtronic Percept Deep Brain Stimulation (daytime aDBS), Device: Medtronic Percept Deep Brain Stimulation (nighttime aDBS)Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 25-75.
- Diagnosis of idiopathic PD.
- Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe).
- Patient has requested surgical intervention with deep brain stimulation for their disorder or previous enrollment in sponsored IDE (G220241) to use Percept PC wired to subgaleal sensing, if patients have ongoing daytime fluctuations or sleep dysfunction despite cDBS optimization.
- Normal preoperative brain MRI.
Key exclusion criteria (7 listed)
- Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications.
- Patient meets criteria for a psychogenic movement disorder.
- Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
- Significant untreated depression (BDI-II score >20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).
- Any personality or mood symptoms that study personnel believe will interfere with study requirements.
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 (cDBS)Also: deep brain stimulation, DBS, cDBS, continuous DBSUsing the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus. | Device | Daytime adaptive DBS Programming, Nighttime adaptive DBS programming, Open-loop continuous deep brain stimulation |
| Medtronic Percept Deep Brain Stimulation (daytime aDBS)Also: aDBS, adaptive DBS, adaptive deep brain stimulationUsing the Percept pulse generator, patients receive daytime adaptive stimulation to the subthalmaic nucleus. | Device | Daytime adaptive DBS Programming, Open-loop continuous deep brain stimulation |
| Medtronic Percept Deep Brain Stimulation (nighttime aDBS)Also: aDBS, adaptive DBS, adaptive deep brain stimulationUsing the Percept pulse generator, patients receive nighttime adaptive stimulation to the subthalmaic nucleus. | Device | Nighttime adaptive DBS programming, Open-loop continuous deep brain stimulation |
Primary outcome
Change in number of bothersome movement and/or sleep episodes on adaptive deep brain stimulation compared to open-loop deep brain stimulation
Time frame: Baseline, aDBS testing, and during Blinded Assessment
Troublesome movement and/or sleep episodes will be detected using validated home wearable devices along with participant self-reporting.
2 secondary outcomes
Change in MDS-UPDRS III scores
Time frame: Baseline, aDBS testing, and Blinded Assessment
Change in Total Electrical Energy Delivered (TEED)
Time frame: Baseline, aDBS testing, and Blinded Assessment
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 14 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Research Manager contact
Simon Little principal investigator
University of California, San Francisco
Philip Starr principal investigator
University of California, San Francisco
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 (cDBS), Medtronic Percept Deep Brain Stimulation (daytime aDBS) and Medtronic Percept Deep Brain Stimulation (nighttime aDBS) in people with PD - Parkinson's Disease, run by University of California, San Francisco 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 10 inclusion and 7 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 14 Sep 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 Clinical Research Coordinator (5175152739, sebastian.liu@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of bothersome movement and/or sleep episodes on adaptive deep brain stimulation compared to open-loop deep brain stimulation (time frame: Baseline, aDBS testing, and during Blinded Assessment). 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 14 Sep 2026.