Brain-Machine Interface for Freezing of Gait

September 16, 2025 updated by: Alfonso Fasano, University of Toronto

Adaptive Cortical Neuromodulation Using a Brain-machine Interface to Treat Freezing of Gait in Parkinson's Disease.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Movement Disorders Centre - Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECoG implantation
Patients will be implanted with high-density cortical ECoG arrays during DBS surgery.
Other: Brain Stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Duration FOG episodes
Time Frame: 7-day experiment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Chronic Coupling between Cortex and Basal Ganglia
Time Frame: 7-day experiment
The aim is to explore the chronic coupling between cortex and basal ganglia by means of deep brain recordings. This is an exploratory opportunity that will be pursued while carrying out the main aims. However, DBS electrodes will not be turned on to provide stimulation until after they exit the study, after which regular standard-of-care DBS programming will occur.
7-day experiment
Exploring BMI Control to Trigger and Study FOG
Time Frame: 7-day experiment
It has never been established if individuals with FOG display typical or impaired performance in brain-machine interfaces (BMI) control and whether they can experience phenomena similar to FOG while performing these virtual tasks. This is also an exploratory aim. Participants will be trained to guide virtual effectors (cursors) on a screen using the implanted BMI. The aim is to stablish if standard BMI tasks can trigger FOG-like phenomena. Such occurrence would largely augment the possibility of testing new neuromodulation paradigms to prevent and abolish FOG in laboratory settings.
7-day experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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