- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291687
tDCS as Treatment for Motor Function (PSP)
Transcranial Direct Current Stimulation as a Treatment for Motor Function in Participants Living With Progressive Supranuclear Palsy, Corticalbasal Syndrome Degeneration, or Parkinson's Disease
Study Overview
Status
Intervention / Treatment
Detailed Description
Previous preliminary results are sufficiently impressive to suggest that tDCS stimulation does have the potential to improve motor function when that ability is trained during stimulation. In the proposed study, the investigators will assess whether walking sessions combined with tDCS lead to improvements in motor function: gait, articulation, eye gaze, and motor dexterity. In addition, the investigators wish to examine if such results can be replicated in people with other conditions, such as cortical basal syndrome, and Parkinson's disease. The rationale for including people living with these conditions is the overlap in motor and cortical network dysfunction observed across these disorders. All three conditions involve impairment of motor initiation, gait, coordination, and executive motor control due to degeneration in frontal-subcortical pathways. This extension will also allow for comparison of stimulation responsiveness across related diagnostic groups and provide insight into disease-specific factors influencing motor recovery potential.
Previous tDCS studies have found significant results with sample sizes between 10-20 participants for a two-round study comparing training sessions with real tDCS versus sessions done without tDCS. However, the investigators plan to recruit 30 participants living with each condition as this will allow us to examine results per group, but also how the individual groups compare.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alice Zhang, B.Sc
- Phone Number: 2522 (416) 785-2500
- Email: azhang4@research.baycrest.org
Study Contact Backup
- Name: Tyler Roncero, Ph.D
- Phone Number: ext. 2522 T (416) 785-2500
- Email: croncero@research.baycrest.org
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6A 2E1
- Recruiting
- Baycrest Academy of Health Sciences and Geriatric Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Participants must be able to walk unassisted, or with the assistance of a walker or cane, and be individuals who walk daily.
2. Participants should have a sufficient level of English to be able to express themselves verbally, be able to read and follow instructions.
Exclusion Criteria:
- 3. Individuals with metal implants within the brain such as shunts will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real tDCS Stimulation:
Participants will be exposed to 20 min of tDCS brain stimulation while undergoing training on cognitive tasks.
|
The Crossover design will enable us to use each participant as their own control.
|
|
Placebo Comparator: Sham Arm
Participants will be exposed to 20 min of tDCS sham/placebo stimulation while undergoing training on cognitive tasks.
Participants will have the exact same apparatus used but with no stimulation.
|
Participants will be exposed to the brain stimulation protocol while undergoing certain motor task during the training sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait speed
Time Frame: Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.
|
Within each round, scores from the final week and final session of real tDCS stimulation will be compared to performance during the first week and final sham tDCS session to check for significant improvement.
Our primary outcome measures will be those found for gait; for example, a faster walking time subsequent to tDCS stimulation compared to the placebo baseline.
Participants will also return two weeks later for a post-stimulation evaluation to check if improvement was maintained.
To check if the arrangement of electrodes impacts the effect, times from the final tDCS session of each round will be compared.
|
Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Articulation Quality (Clinician-Rated Speech Production on Word and Sentence Repetition)
Time Frame: Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.
|
Articulation will be assessed using a clinician-administered repetition task involving single words and short sentences.
Speech production quality will be rated by the clinician using a standardized 5-point articulation quality scale (1 = severely distorted, 5 = normal/near-normal production).
The reported value will be the rating score.
|
Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.
|
|
Eye-Gaze Control (Clinician-Rated Ability to Track a Moving Target)
Time Frame: Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.
|
Eye-gaze performance will be evaluated using a bedside oculomotor task.
Participants are asked to follow a moving pencil with their eyes while keeping their head still.
A clinician will rate eye-gaze control on a standardized 3-point scale (0 = unable, 1 = inconsistent, 2 = consistent and accurate).
The reported value will be the rating score.
|
Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tyler Roncero, Ph.D, Baycrest Academy of Health Sciences and Geriatric Research
- Principal Investigator: Howard Chertkow, MD, Baycrest Academy of Health Sciences and Geriatric Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Tauopathies
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Cranial Nerve Diseases
- Ophthalmoplegia
- Ocular Motility Disorders
- Paralysis
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Corticobasal Degeneration
- Parkinson Disease
- Supranuclear Palsy, Progressive
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- 21-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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