Brain-Machine Interface for Freezing of Gait

NCT06642519 | Enrolling By Invitation DMC

• 1 other identifier: 24-5435
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Gait problems in Parkinson's disease (PD), especially freezing of gait (FOG), greatly affect quality of life. While deep brain stimulation (DBS) is a highly effective treatment for many motor symptoms of PD, it is less effective for, or can even worsen, gait issues. The primary motor cortex (M1) plays a crucial role in the network that controls gait, particularly in initiating movement. Changes in local field potentials (LFPs) from the subthalamic nucleus (STN) are associated with different aspects of gait. However, detecting abnormal brain activity related to FOG requires a method called electrocorticography (ECoG), which has revealed that during FOG, there is increased beta-gamma phase amplitude coupling (PAC) in the M1. Brain-machine interfaces (BMIs) have shown promise in understanding motor functions by decoding brain activity. It is believed that BMIs could provide both accurate indicators of FOG and targeted treatments for it in PD. Our objectives are to use a high-density ECoG-based BMI to both record and stimulate brain activity during real-world gait and FOG in PD patients who are undergoing standard DBS procedures. Our goals are to improve our understanding of the brain's role in FOG and normal gait in PD and to develop new treatments based on cortical stimulation. Aim 1 - Identify gait biomarkers: brain activity from the M1/SMA cortex during different phases of walking and during FOG episodes, both with and without medication will be recorded. Machine learning will be used to identify the brain patterns linked to FOG. Aim 2 - Use cortical stimulation to stop FOG: Cortical stimulation and its effects on leg and trunk movements will be studied by measuring muscle activity, movement, and posture during different states, such as resting, standing, walking, and during FOG episodes. The type of stimulation which is most effective at stopping FOG will be identified.

Conditions

Parkinson Disease; Freezing of Gait Symptoms in Parkinson's Disease

Keywords

Brain-Machine interface; Freezing of Gait; Triggered stimulation; Adaptive Stimulation

Outcome Measures

Primary Outcomes (1)

• Number and Duration FOG episodes

  The number and duration of FOG episodes either with or without stimulation, including the number/duration of FOG episodes with optimal stimulation.

  7-day experiment

Secondary Outcomes (2)

• Measurement of Chronic Coupling between Cortex and Basal Ganglia

  7-day experiment

• Exploring BMI Control to Trigger and Study FOG

  7-day experiment

Study Arms (1)

ECoG implantation

EXPERIMENTAL

Patients will be implanted with high-density cortical ECoG arrays during DBS surgery.

Other: Brain Stimulation

Interventions

Brain Stimulation OTHER

Studies will be conducted using ECoG, with a bidirectional interface, both recording (aim/phase 1) and stimulating (aim/phase 2), during real-world gait and FOG in PD patients over the course of 7-days of gait experiments.

ECoG implantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PD fulfilling standard criteria for bilateral STN/GPi DBS surgery
• Debilitating FOG in the off-medication condition with only partial response to levodopa (defined as the witnessed occurrence of FOG during the on phase of the pre-DBS L-dopa challenge)
• Clinically established FOG (i.e. reported by patient/caregiver AND seen by the examiner in the clinic)
• Able to provide informed consent, comply with study protocol

You may not qualify if:

• Prior ischemic stroke, intracranial hemorrhage, or intracerebral mass
• Previous brain surgery
• Other disorders potentially biasing assessment
• Absence of FOG in the medication on condition (a population already manageable with current standard of treatment).

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

CA (1)