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

NCT ID: NCT04043403

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2025-08-08

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Device: Summit RC+S

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.

Group Type: EXPERIMENTAL

Open Loop DBS

Intervention Type: DEVICE

Standard DBS therapy at a constant frequency and voltage

Adaptive (Closed Loop) DBS

Intervention Type: DEVICE

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

Intermittent Open Loop DBS

Intervention Type: 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: Percept PC

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

Group Type: EXPERIMENTAL

Open Loop DBS

Intervention Type: DEVICE

Standard DBS therapy at a constant frequency and voltage

Adaptive (Closed Loop) DBS

Intervention Type: DEVICE

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

Interventions

Open Loop DBS

Standard DBS therapy at a constant frequency and voltage

Intervention Type: DEVICE

Adaptive (Closed Loop) DBS

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Helen M. Bronte-Stewart

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen M. Bronte-Stewart, MD,MSE

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

52548

Identifier Type: -

Identifier Source: org_study_id