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

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

This study is testing a new type of brain stimulation that adjusts itself based on a person's movements to see if it can help people with Parkinson's disease who struggle with freezing while walking.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT04043403 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility of an adaptive deep brain stimulation (aDBS) system that responds to individual neural and kinematic feedback to treat freezing of gait (FOG) in patients with Parkinson's disease. Unlike traditional open-loop deep brain stimulation, which delivers constant stimulation, this approach aims to customize stimulation parameters based on real-time patient data. The study will involve patients who are already eligible for or have received standard deep brain stimulation treatment, assessing their responses over a series of follow-up visits. The goal is to improve gait and overall quality of life for those affected by Parkinson's disease.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with clinically-established Parkinson's disease who experience freezing of gait and meet specific criteria for deep brain stimulation.

Not a fit: Patients with advanced Parkinson's disease (Hoehn and Yahr stage 5), untreated psychiatric conditions, or significant surgical morbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance mobility and reduce episodes of freezing of gait in Parkinson's patients.

How similar studies have performed: While adaptive deep brain stimulation is a novel approach, previous studies have shown promise in using responsive stimulation techniques for various neurological conditions.

Eligibility criteria

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Where this trial is running

Stanford, California

• Stanford University — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: Helen M. Bronte-Stewart, MD,MSE — Stanford University
• Study coordinator: Helen Bronte-Stewart, MD MSE

Conditions Parkinson Disease