Status:
COMPLETED
Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
Lead Sponsor:
Stanford University
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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, o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04043403
Start Date
October 28 2019
End Date
August 8 2025
Last Update
October 15 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305