Clinical trial NCT04043403: Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
Official title: Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will have either the Percept PC system, or Summit RC+S system from Medtronic PLC implanted.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to Stimulation Condition
timeFrame: 3 Months
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to quality of life
timeFrame: 3 Months
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to speech
timeFrame: 6 Months
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to gait
timeFrame: 3 Months
Secondary outcomes:
measure: Gait Parameters: Arrhythmicity
timeFrame: Collected up to 10 days every 3 months
measure: Gait Parameters: Mean Shank Angular Velocity
timeFrame: Collected up to 10 days every 3 months
measure: Gait Parameters: Mean Gait Cycle Time
timeFrame: Collected up to 10 days every 3 months
measure: Percent Time Freezing
timeFrame: Collected up to 10 days every 3 months
measure: The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
timeFrame: Collected up to 10 days every 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Helen M. Bronte-Stewart, MD,MSE
role: PRINCIPAL_INVESTIGATOR
References: