Parkinson DiseaseNCT06642519
Brain-Machine Interface for Freezing of Gait
A study testing Brain Stimulation in people with Parkinson Disease and Freezing of Gait Symptoms in Parkinson's Disease, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Freezing of Gait Symptoms in Parkinson's Disease
- What is being tested?
- Brain Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 10 Apr 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: 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.
Read more
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.
- Being tested
- Brain Stimulation
- Keywords
- Brain-Machine interface, Freezing of Gait, Triggered stimulation, Adaptive Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ECoG implantation | Experimental | Patients will be implanted with high-density cortical ECoG arrays during DBS surgery. Receives: Other: Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7-day experiment
Secondary outcomes (2)
Measurement of Chronic Coupling between Cortex and Basal Ganglia
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.
Measured: 7-day experiment
Exploring BMI Control to Trigger and Study FOG
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.
Measured: 7-day experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Apr 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fasano, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642519
- Sponsor's protocol ID
- 24-5435
- Status last verified
- Sep 2025
- First submitted
- 11 Oct 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Cortical Neuromodulation Using a Brain-machine Interface to Treat Freezing of Gait in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT06642519
- Acronym / sponsor ID
- 24-5435
- Keywords
- Brain-Machine interface, Freezing of Gait, Triggered stimulation, Adaptive Stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECoG implantation | Experimental | Other: Brain StimulationPatients will be implanted with high-density cortical ECoG arrays during DBS surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain StimulationStudies 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. | Other | ECoG implantation |
Primary outcome
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.
2 secondary outcomes
Measurement of Chronic Coupling between Cortex and Basal Ganglia
Time frame: 7-day experiment
Exploring BMI Control to Trigger and Study FOG
Time frame: 7-day experiment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Stimulation in people with Parkinson Disease and Freezing of Gait Symptoms in Parkinson's Disease, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Duration FOG episodes (time frame: 7-day experiment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.