Adaptive Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease

NCT06819020 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 25-43493
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if adaptive deep brain stimulation (DBS) can decrease or prevent freezing of gait in participants with Parkinson's disease.

Conditions

Parkinson Disease

Keywords

Neuromodulation; Deep Brain Stimulation; Freezing of Gait; Adaptive DBS; Gait Impairment; Parkinson disease

Outcome Measures

Primary Outcomes (1)

• Freezing of gait

  Freezing of gait episodes will be detected using validated home wearable devices along with participant self-reporting.

  Baseline and 2 years

Secondary Outcomes (9)

• Change in Gait

  Baseline and 2 years

• Change in Balance

  Baseline and 2 years

• Change in MDS-UPDRS III scores

  Baseline and 2 years

• Change in Stride Length

  Baseline and 2 years

• Change in Stride Time

  Baseline and 2 years

Study Arms (3)

Open-loop deep brain stimulation

ACTIVE COMPARATOR

Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation.

Device: Percept RC

Adaptive deep brain stimulation (ramp-up)

ACTIVE COMPARATOR

Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving increased stimulation in-response to gait-behavior biomarker.

Device: Percept RC

Adaptive deep brain stimulation (ramp-down)

ACTIVE COMPARATOR

Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving decreased stimulation in-response to gait-behavior biomarker.

Device: Percept RC

Interventions

Percept RC DEVICE

Using the Percept RC pulse generator, patients receive clinically-optimized open loop stimulation to the pallidum/subthalmaic nucleus.

Also known as: Continuous deep brain stimulation

Open-loop deep brain stimulation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give informed consent for the study
• Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
• Patient has requested surgical intervention with deep brain stimulation for their disorder
• No magnetic resonance (MR) abnormalities that suggest an alternative diagnosis or contraindicate surgery
• Absence of significant cognitive impairment (score of 21 or greater on the Montreal Cognitive Assessment (MoCA)),
• Signed informed consent
• Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
• Age 21-75
• Diagnosis of idiopathic PD with duration of motor symptoms for 3 years or greater
• Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist.
• UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score, and motor fluctuations with at least 2 hours per day of on time without dyskinesia or with non-bothersome dyskinesia.
• OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management
• Patients with gait impairments including freezing of gait off medication.
• Ability of patient and/or caregivers to recharge the system evaluated by all clinicians and study personnel.

You may not qualify if:

• Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications
• Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance.
• Pregnancy: all women of child bearing 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.
• Subjects who require Electroconvulsive therapy (ECT), Repetitive Transcranial Magnetic Stimulation (rTMS) or diathermy
• Implanted stimulation systems such as cochlear implant, pacemaker, defibrillator, or neurostimulator
• Previous cranial surgery
• Drug or alcohol abuse
• Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These criteria are performance of more than two standard deviations below appropriate norms, for tests from two or more of these five cognitive domains: attention, executive function, language, memory, and visuospatial tests.
• Known allergies to the implantable device components including titanium, polyurethane, silicone, and nylon.

Sponsors & Collaborators

• Doris Wang, MD, PhD: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Doris D Wang, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Neurological Surgery

Model Details: In a small, double-blinded trial, the investigators will compare the effects of aDBS versus conventional open-loop DBS on gait. Participants will be randomized to either open-loop DBS or different aDBS conditions (10 days per condition, with counterbalancing the order of stimulation within subject and randomizing this counterbalanced order across subjects). Participants will be perform gait tasks at home along with doing their everyday activities with a wearable device that tracks gait metrics and FOG episodes. Gait and balance measurements, external wearable data collection, and UPDRS III will be performed at the end of the 10-day stimulation period for each condition in-person.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)