skip to Main Content

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

Sponsor:

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, 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.

Criteria

Inclusion Criteria:

– Clinically-established PD

– Meets criteria for STN DBS eligibility as part of patient’s standard medical care

– 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 > 25

– Freezing of gait questionnaire (FOG-Q) score ≥ 1 and/or gait sub-score (Item 3.10) of
MDS- UPDRS III ≥ 1

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, or diathermy

– Are pregnant or lactating

– Has a cranial metallic implant

Locations

  • Stanford University, Stanford, California, United States, 94305
Back To Top