Parkinson DiseaseNCT04043403

Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback

A study testing Open Loop DBS, Adaptive (Closed Loop) DBS and Intermittent Open Loop DBS in people with Parkinson Disease, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Parkinson Disease
What is being tested?: Open Loop DBS, Adaptive (Closed Loop) DBS and Intermittent Open Loop DBS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 28 Oct 2019to 8 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinically-established PD
Meets criteria for STN DBS eligibility as part of patient's standard medical care or already implanted in the STN with Percept(TM) PC
The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
Age > 18
Freezing of gait questionnaire (FOG-Q) score ≥ 1 and/or gait sub-score (Item 3.10) of MDS- UPDRS III ≥ 1
Greater than or equal to 1.2 microVp between 8-35 Hz on either the LSTN or RSTN (Percept (TM) PC cohort only)

Who cannot join

Dementia
Untreated psychiatric disease
Hoehn and Yahr stage 5 on or off medication (non-ambulatory)
Age > 80
Major surgical morbidities such as severe hypertension, coagulopathy and certain metabolic conditions that might increase the risk of hemorrhage or other surgical complications
Presence of a cardiac pacemaker/defibrillator

Show all 11Show fewer

Inability to understand/sign consent
Requires rTMS, ECT, MRI (Summit(R) RC+S cohort only), or diathermy
Are pregnant or lactating
Has a cranial metallic implant
History of seizures or epilepsy

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Deep Brain Stimulation of the subthalamic nucleus (STN) has become a standard of care, FDA-approved treatment for Parkinson's disease, with stimulation delivered at a constant amplitude and voltage, operating in an open-loop fashion that does not respond to a patient's current state. Although gait deficits and freezing of gait may initially respond to continuous open-loop deep brain stimulation (olDBS) and medication, the symptoms often recur over time.

The episodic and predictable nature of FOG makes it well suited for adaptive DBS (aDBS) and a device that overcomes the limitations of traditional high frequency olDBS and is capable of adapting therapy either in the frequency or intensity domain transiently to treat FOG while also treating other PD signs such as tremor and bradykinesia.

The purpose of this study is to determine the feasibility of an adaptive DBS system, that responds to patient-specific neural and kinematic variables with customized DBS parameters.

Conditions: Parkinson Disease
Being tested: Open Loop DBS, Adaptive (Closed Loop) DBS, Intermittent Open Loop 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.

Open Loop DBSDevice
Standard DBS therapy at a constant frequency and voltage
Adaptive (Closed Loop) DBSDevice
DBS that responds to neural (Percept PC and Summit RC+S) or kinematic (Summit RC+S) features of patient's current state
Intermittent Open Loop DBSDevice
Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.

Study groups in NCT04043403
Study group	Role	What they receive
Device: Summit RC+S	Experimental	1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural or kinematic features of patient's current state 3. Intermittent Open Loop DBS: Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals. Receives: Device: Open Loop DBS; Device: Adaptive (Closed Loop) DBS; Device: Intermittent Open Loop DBS
Device: Percept PC	Experimental	1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural features of patient's current state Receives: Device: Open Loop DBS; Device: Adaptive (Closed Loop) DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Related to Stimulation Condition
A Customized Adverse Events and Tolerability Questionnaire will measure the absence/presence and frequency of paresthesias, and muscle twitching relative to each stimulation condition occurring during the respective study visit
Measured: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, and IV
The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, and IV will:
(I) Evaluate mentation, behavior, and mood (II) Evaluate a patient's activities of daily life (IV) Measure the presence/severity of dyskinesias and other complications of therapy over time Summed score ranges from 0 to 128 with higher numbers indicating worse impairment.
Measured: The questionnaire was assessed on the first day of a planned research visit (occurring from first research visit at month 3, through up to 3 years)
MDS-UPDRS III Speech Item Score
The MDS-UPDRS III speech item subscale will measure changes in speech related to each stimulation condition to establish safety and tolerability for speech. Subitem score is scores on ordinal scale between 0 and 4 where higher numbers indicate worse impairment.
Measured: Each task/condition was assessed during one day a planned research visit (occurring from second research visit at month 6, through up to 3 years)
Freezing of Gait Questionnaire (FOG-Q) Score
The Freezing of Gait Questionnaire (FOG-Q) will be used to record changes in gait over time as a measure of safety and tolerability. Scores range from 0 to 28 with higher scores indicating worse impairment.
Measured: The questionnaire was assessed on the first day of a planned research visit (occurring from first research visit at month 3, through up to 3 years)

Secondary outcomes (5)

Gait Parameters: Arrhythmicity
Variability in the stride time during a gait task. Stride time is the total time required to complete one full gait cycle as measured as the time between initial ground contact of one foot and the subsequent ground contact of the same foot. The variability is then measured by taking the cofficient of variation which is the standard deviation divided by the mean. Higher variability is indicative of worse (more arrhthmic) gait.
Measured: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
Gait Parameters: Mean Shank Angular Velocity
Median of the average score per participant of the peak shank angular velocities of every stride during the gait task. Lower peak shank angular velocity is indicative of worse gait,
Measured: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
Gait Parameters: Mean Gait Cycle Time
Median of the average length of time of each stride during a gait task. Higher values are indicative of slower gait.
Measured: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
Percent Time Freezing
The percentage of the gait task was a participant frozen. Ranges from 0 to 100 where higher scores indicate worse gait.
Measured: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Portion of the scale assesses the motor signs of PD. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 132 where higher score indicate worse impairment.
Measured: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 20198 Aug 2025

First posted2 Aug 2019
Study start28 Oct 2019
Primary completion8 Aug 2025
Study completion8 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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: Parallel groups
Model description: Participants will have either the Percept PC system, or Summit RC+S system from Medtronic PLC implanted.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04043403
Sponsor's protocol ID: 52548
Other IDs: UH3NS107709
Status last verified: Sep 2026
First submitted: 30 Jul 2019
Last updated: 7 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: De-identified participant data, including neural and kinematic data will be shared on the Data Archive for the Brain Initiative (DABI).

Publications

Negi AS, Cui C, Wilkins KB, Lambert EF, Melbourne JA, Petrucci MN, Hoffman SL, Aditham S, Diep C, Dorris HJ, Akella P, Parisi L, Gala AS, Herron JA, Bronte-Stewart HM. Low-Frequency Adaptive Deep Brain Stimulation for Parkinson's Disease. medRxiv [Preprint]. 2025 Dec 27:2025.12.17.25342333. doi: 10.64898/2025.12.17.25342333.
PubMed 41480041
Wilkins KB, Petrucci MN, Lambert EF, Melbourne JA, Gala AS, Akella P, Parisi L, Cui C, Kehnemouyi YM, Hoffman SL, Aditham S, Diep C, Dorris HJ, Parker JE, Herron JA, Bronte-Stewart HM. Beta burst-driven adaptive deep brain stimulation for gait impairment and freezing of gait in Parkinson's disease. Brain Commun. 2025 Jul 9;7(4):fcaf266. doi: 10.1093/braincomms/fcaf266. eCollection 2025.
PubMed 40677701
Karjagi S, Kehnemouyi YM, Petrucci MN, Parisi L, Lambert EF, Melbourne JA, Akella P, Wilkins KB, O'Day J, Dorris HJ, Diep C, Gala AS, Cui C, Hoffman SL, Acharyya P, Herron JA, Bronte-Stewart HM. Real-Time Kinematic Adaptive Deep Brain Stimulation Safely Reduces Gait Impairment and Freezing of Gait in Parkinson's Disease. medRxiv [Preprint]. 2026 Mar 2:2026.02.23.26346487. doi: 10.64898/2026.02.23.26346487.
PubMed 41867218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
ClinicalTrials.gov ID: NCT04043403
Acronym / sponsor ID: 52548
Conditions: Parkinson Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: 28 Oct 2019 (actual)
Primary completion: 8 Aug 2025 (actual)
Study completion: 8 Aug 2025 (actual)
First posted: 2 Aug 2019 (actual)
Results: Posted 7 Oct 2026

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 determine the feasibility of an adaptive DBS system, that responds to patient-specific neural and kinematic variables with customized DBS parameters.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Participants will have either the Percept PC system, or Summit RC+S system from Medtronic PLC implanted.

Arm	Type	Receives
Device: Summit RC+S	Experimental	Device: Open Loop DBS, Device: Adaptive (Closed Loop) DBS, Device: Intermittent Open Loop DBS1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural or kinematic features of patient's current state 3. Intermittent Open Loop DBS: Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.
Device: Percept PC	Experimental	Device: Open Loop DBS, Device: Adaptive (Closed Loop) DBS1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural features of patient's current state

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Clinically-established PD
Meets criteria for STN DBS eligibility as part of patient's standard medical care or already implanted in the STN with Percept(TM) PC
The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
Age > 18

Key exclusion criteria (11 listed)

Dementia
Untreated psychiatric disease
Hoehn and Yahr stage 5 on or off medication (non-ambulatory)
Age > 80
Major surgical morbidities such as severe hypertension, coagulopathy and certain metabolic conditions that might increase the risk of hemorrhage or other surgical complications

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
Open Loop DBSStandard DBS therapy at a constant frequency and voltage	Device	Device: Percept PC, Device: Summit RC+S
Adaptive (Closed Loop) DBSDBS that responds to neural (Percept PC and Summit RC+S) or kinematic (Summit RC+S) features of patient's current state	Device	Device: Percept PC, Device: Summit RC+S
Intermittent Open Loop DBSControl for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.	Device	Device: Summit RC+S

Primary outcome

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Related to Stimulation Condition
Time frame: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
A Customized Adverse Events and Tolerability Questionnaire will measure the absence/presence and frequency of paresthesias, and muscle twitching relative to each stimulation condition occurring during the respective study visit
The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, and IV
Time frame: The questionnaire was assessed on the first day of a planned research visit (occurring from first research visit at month 3, through up to 3 years)
The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, and IV will: (I) Evaluate mentation, behavior, and mood (II) Evaluate a patient's activities of daily life (IV) Measure the presence/severity of dyskinesias and other complications of therapy over time Summed score ranges from 0 to 128 with higher numbers indicating worse impairment.
MDS-UPDRS III Speech Item Score
Time frame: Each task/condition was assessed during one day a planned research visit (occurring from second research visit at month 6, through up to 3 years)
The MDS-UPDRS III speech item subscale will measure changes in speech related to each stimulation condition to establish safety and tolerability for speech. Subitem score is scores on ordinal scale between 0 and 4 where higher numbers indicate worse impairment.
Freezing of Gait Questionnaire (FOG-Q) Score
Time frame: The questionnaire was assessed on the first day of a planned research visit (occurring from first research visit at month 3, through up to 3 years)
The Freezing of Gait Questionnaire (FOG-Q) will be used to record changes in gait over time as a measure of safety and tolerability. Scores range from 0 to 28 with higher scores indicating worse impairment.

5 secondary outcomes

Gait Parameters: Arrhythmicity
Time frame: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
Gait Parameters: Mean Shank Angular Velocity
Time frame: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
Gait Parameters: Mean Gait Cycle Time
Time frame: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
Percent Time Freezing
Time frame: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)
The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Time frame: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)

Results and safety

Results posted to the registry on 7 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device: Summit RC+S	9	9
Device: Percept PC	3	3

Primary outcome: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Related to Stimulation Condition

Time frame: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years). Number. Unit: Events

Measure	Device: Summit RC+S n = 9	Device: Percept PC n = 3
High Frequency Stepping In Place Visit OFF Deep Brain Stimulation	0	0
High Frequency Stepping In Place Visit Open Loop Deep Brain Stimulation	0	1
High Frequency Stepping In Place Visit Adaptive Deep Brain Stimulation	0	0
High Frequency Stepping In Place Visit Intermittent Open Loop Deep Brain Stimulation	0	–
High Frequency Turning and Barrier Course Visit OFF Deep Brain Stimulation	0	0
High Frequency Turning and Barrier Course Visit Open Loop Deep Brain Stimulation	1	0
High Frequency Turning and Barrier Course Visit Adaptive Deep Brain Stimulation	1	0
High Frequency Turning and Barrier Course Visit Intermittent Open Loop Deep Brain Stimulation	3	–

Population analysed: Some participants of the Summit RC cohort could not perform OFF DBS testing or tolerate frequency switching necessart for Frequency visit. Not all participants completed every visit. Percept PC cohort only completed High Frequency Stepping In Place Visit and High Frequency Turning and Barrier Course and only the conditions OFF DBS, Open Loop DBS, and Adaptive DBS per the protocol. One Percept PC patient was unable to perform OFF testing. Each row represents a stim condition at a visit

Primary outcome: The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, and IV

Time frame: The questionnaire was assessed on the first day of a planned research visit (occurring from first research visit at month 3, through up to 3 years). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Device: Summit RC+S n = 9	Device: Percept PC n = 3
High Frequency Stepping In Place Visit	19 (16 to 27.5)	18 (17 to 20)
High Frequency Turning and Barrier Course Visit	21.5 (14.75 to 33.5)	13 (11.5 to 14.5)
Low Frequency Stepping In Place Visit	21.5 (15.75 to 22)	–
Low Frequency Turning and Barrier Course Visit	14 (14 to 20)	–
Kinematic Stepping In Place Visit	20.5 (17 to 21.5)	–
Kinematic Turning and Barrier Course	19 (17 to 25.5)	–

Primary outcome: MDS-UPDRS III Speech Item Score

Time frame: Each task/condition was assessed during one day a planned research visit (occurring from second research visit at month 6, through up to 3 years). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Device: Summit RC+S n = 9	Device: Percept PC n = 3
High Frequency Stepping In Place Visit OFF Deep Brain Stimulation	1 (1 to 1.75)	1.5 (1.25 to 1.75)
High Frequency Stepping In Place Visit Open Loop Deep Brain Stimulation	1 (1 to 1)	1 (1 to 1.5)
High Frequency Stepping In Place Visit Adaptive Deep Brain Stimulation	1 (1 to 1)	1 (1 to 1.5)
High Frequency Stepping In Place Visit Intermittent Open Loop Deep Brain Stimulation	1 (1 to 1)	–
High Frequency Turning and Barrier Course Visit OFF Deep Brain Stimulation	1 (1 to 1)	1 (1 to 1)
High Frequency Turning and Barrier Course Visit Open Loop Deep Brain Stimulation	1 (1 to 2)	1 (1 to 1.75)
High Frequency Turning and Barrier Course Visit Adaptive Deep Brain Stimulation	1 (1 to 2)	1 (0 to 2)
High Frequency Turning and Barrier Course Visit Intermittent Open Loop Deep Brain Stimulation	1 (1 to 1)	–

Primary outcome: Freezing of Gait Questionnaire (FOG-Q) Score

Measure	Device: Summit RC+S n = 9	Device: Percept PC n = 3
High Frequency Stepping In Place Visit	19 (0 to 20.5)	0 (0 to 3)
High Frequency Turning and Barrier Course Visit	15.5 (2.75 to 20.75)	0 (0 to 0)
Low Frequency Stepping In Place Visit	11.5 (5 to 19.5)	–
Low Frequency Turning and Barrier Course Visit	9 (8 to 11)	–
Kinematic Stepping In Place Visit	16.5 (9 to 18.75)	–
Kinematic Turning and Barrier Course Visit	13 (3 to 18)	–

Population analysed: Not all participants completed every visit. Percept PC cohort only completed High Frequency Stepping In Place Visit and High Frequency Turning and Barrier Course and only the conditions OFF DBS, Open Loop DBS, and Adaptive DBS per the protocol. Each row represents a 3-month visit

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to three years (Timeline per study plan was 6 total research visits, each separated by 3 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device: Summit RC+S	1 of 9 (11.1%)	9 of 9 (100%)	0 of 9
Device: Percept PC	3 of 3 (100%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 41480041Negi AS, Cui C, Wilkins KB, Lambert EF, Melbourne JA, Petrucci MN, Hoffman SL, Aditham S, Diep C, Dorris HJ, Akella P, Parisi L, Gala AS, Herron JA, Bronte-Stewart HM. Low-Frequency Adaptive Deep Brain Stimulation for Parkinson's Disease. medRxiv [Preprint]. 2025 Dec 27:2025.12.17.25342333. doi: 10.64898/2025.12.17.25342333.
Results publication: PubMed 40677701Wilkins KB, Petrucci MN, Lambert EF, Melbourne JA, Gala AS, Akella P, Parisi L, Cui C, Kehnemouyi YM, Hoffman SL, Aditham S, Diep C, Dorris HJ, Parker JE, Herron JA, Bronte-Stewart HM. Beta burst-driven adaptive deep brain stimulation for gait impairment and freezing of gait in Parkinson's disease. Brain Commun. 2025 Jul 9;7(4):fcaf266. doi: 10.1093/braincomms/fcaf266. eCollection 2025.
Results publication: PubMed 41867218Karjagi S, Kehnemouyi YM, Petrucci MN, Parisi L, Lambert EF, Melbourne JA, Akella P, Wilkins KB, O'Day J, Dorris HJ, Diep C, Gala AS, Cui C, Hoffman SL, Acharyya P, Herron JA, Bronte-Stewart HM. Real-Time Kinematic Adaptive Deep Brain Stimulation Safely Reduces Gait Impairment and Freezing of Gait in Parkinson's Disease. medRxiv [Preprint]. 2026 Mar 2:2026.02.23.26346487. doi: 10.64898/2026.02.23.26346487.
Individual participant dataSharing planned: Yes. De-identified participant data, including neural and kinematic data will be shared on the Data Archive for the Brain Initiative (DABI).

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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. This study is not recruiting at the moment.

Helen M. Bronte-Stewart, MD,MSE principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Open Loop DBS, Adaptive (Closed Loop) DBS and Intermittent Open Loop DBS in people with Parkinson Disease, run by Stanford University 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 11 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: finished, as of the sponsor's last update on 7 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?

Yes. Results are posted in the registry (first posted 7 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Related to Stimulation Condition (time frame: Each task/condition was assessed during one day at a planned research visit (occurring from first research visit at month 3, through up to 3 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04043403, which also lists 3 linked publications.

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 7 Oct 2026.