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

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Trial ID: NCT04043403

Age - 18 Years-80 Years Gender - All Accepting Healthy Volunteers - No

Purpose

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.

Official Title

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

Stanford Investigator(s)

Helen Bronte-Stewart, MD, MS
Helen Bronte-Stewart, MD, MS

John E. Cahill Family Professor, Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery

Eligibility


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

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Intervention(s):

device: Open Loop DBS

device: Adaptive (Closed Loop) DBS

device: Intermittent Open Loop DBS

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sudeep Aditham
650-723-6709

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