By InvitationNot Applicable

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

United States20 participantsStarted 2026-01-31

Plain-language 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.

Who can participate

Age range21 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Freezing of gait

Timeframe: Baseline and 2 years

Trial details

NCT IDNCT06819020

SponsorDoris Wang, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-08-01

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