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

Stanford University12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to Stimulation Condition

A Customized Adverse Events and Tolerability Questionnaire will measure the absence/presence and frequency of paresthesias, and muscle twitching relative to each stimulation condition

Time frame: 3 Months

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to quality of life

The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, and IV will: (I) Evaluate mentation, behavior, and mood (II) Evaluate a patient's activities of daily life (IV) Measure the presence/severity of dyskinesias and other complications of therapy over time

Time frame: 3 Months

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to speech

The Speech Intelligibility Test (SIT) will measure changes in speech related to each stimulation condition.

Time frame: 6 Months

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to gait

The Freezing of Gait Questionnaire (FOG-Q) will be used to record changes in gait over time

Time frame: 3 Months