NCT06642519

Brain-Machine Interface for Freezing of Gait

ENROLLING BY INVITATION NA Last updated 22 September 2025

What this trial tests

NA trial testing Brain Stimulation in Parkinson Disease in 10 participants. Enrolling by invitation.

Timeline

10 April 2025

Primary endpoint
30 October 2026

30 July 2027

Quick facts

Lead sponsor	University of Toronto
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	10 April 2025
Primary completion	30 October 2026
Estimated completion	30 July 2027
Sites	1 location across Canada

Drugs / interventions tested

• Brain Stimulation

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Freezing of Gait Symptoms in Parkinson's Disease — all drugs for Freezing of Gait Symptoms in Parkinson's Disease →

Sponsor

University of Toronto

Who can join

Eligibility, any sex, with Parkinson Disease or Freezing of Gait Symptoms in Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Brain-Computer Interfaces in Parkinson's Disease Rehabilitation.
   Ortega-Robles E, Carino-Escobar RI, Cantillo-Negrete J, Arias-Carrión O. · · 2025 · cited 3× · PMID 40862861 · DOI 10.3390/biomimetics10080488