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

NCT04043403 | Completed DMC FDA Device

• 1 other identifier: 52548
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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

  3 Months

Secondary Outcomes (5)

• Gait Parameters: Arrhythmicity

  Collected up to 10 days every 3 months

• Gait Parameters: Mean Shank Angular Velocity

  Collected up to 10 days every 3 months

• Gait Parameters: Mean Gait Cycle Time

  Collected up to 10 days every 3 months

• Percent Time Freezing

  Collected up to 10 days every 3 months

• The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III

  Collected up to 10 days every 3 months

Study Arms (2)

Device: Summit RC+S

EXPERIMENTAL

1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural or kinematic features of patient's current state 3. Intermittent Open Loop DBS: Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.

Device: Open Loop DBS; Device: Adaptive (Closed Loop) DBS; Device: Intermittent Open Loop DBS

Device: Percept PC

EXPERIMENTAL

1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage 2. Adaptive (Closed Loop) DBS: DBS that responds to neural features of patient's current state

Device: Open Loop DBS; Device: Adaptive (Closed Loop) DBS

Interventions

Open Loop DBS DEVICE

Standard DBS therapy at a constant frequency and voltage

Device: Percept PC; Device: Summit RC+S

Adaptive (Closed Loop) DBS DEVICE

DBS that responds to neural (Percept PC and Summit RC+S) or kinematic (Summit RC+S) features of patient's current state

Device: Percept PC; Device: Summit RC+S

Intermittent Open Loop DBS DEVICE

Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.

Device: Summit RC+S

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Helen M. Bronte-Stewart, MD,MSE

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will have either the Percept PC system, or Summit RC+S system from Medtronic PLC implanted.

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 2, 2019
• Study Start: October 28, 2019
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (1)