NCT04043403Completed
Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 30 Jul 2019
- Start date
- 28 Oct 2019
- Primary completion date
- 8 Aug 2025
- Lead sponsor
- Stanford University
- Diseases
- Parkinson disease
- NCT number
- NCT04043403
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 28 Oct 2019 to the primary completion date, 8 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hoehn and Yahr stage 5 on or off medication (non-ambulatory)
- Has a cranial metallic implant
Other illness
- Dementia
- Untreated psychiatric disease
- 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
- History of seizures or epilepsy
Age
- Age \> 80
Other
- Inability to understand/sign consent
- Requires rTMS, ECT, MRI (Summit(R) RC+S cohort only), or diathermy
- Are pregnant or lactating
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.