Actively Recruiting
Quantitative and Repetitive TMS in ALS - Recruiting for Stage 2
Led by Sunnybrook Health Sciences Centre · Updated on 2024-09-19
15
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Stage 1 \[Enrolment closed\]: The goal of this open-label pilot clinical trial is to evaluate the safety and feasibility of accelerated, repetitive transcranial magnetic stimulation (rTMS) using continuous theta-burst stimulation (cTBS) in patients with ALS. Stage 2 \[CURRENTLY ENROLLING\]: The goal of this open-label pilot clinical trial is to evaluate the safety, tolerability and target engagement of accelerated, high dose cTBS using TMS in patients with ALS.
CONDITIONS
Official Title
Quantitative and Repetitive TMS in ALS - Recruiting for Stage 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis with ALS as per the 2020 Gold Coast Criteria
- Age 18 years or older
- Able to provide informed consent for study procedures and treatments
- Allowed to start or continue standard ALS treatments including riluzole and edaravone
- Able to lie supine without BiPAP or breathing discomfort for at least 1 hour
- No contraindications to TMS such as metal implants in head or neck, implanted pumps or stimulators, pacemaker, cochlear implants, or history of epilepsy
- Use of medications affecting TMS in a stable regimen accepted after 30 days or 2-week washout
- History of seizure, convulsion, or epilepsy allowed under certain conditions
You will not qualify if you...
- Known diagnosis of dementia
- Definitely or possibly pregnant
- Allergy to Ag-AgCl electrode gel
- Unable to tolerate TMS procedures
- Lack of or inability to perform baseline MRI due to orthopnea, large body habitus, claustrophobia, or metallic implants
- Previous rTMS treatment for any indication
- Increased intracranial pressure, brain lesions, history of seizure except ECT-induced or febrile seizure of infancy, significant head trauma with cerebrovascular injury
- Intracranial implants or metal objects near head that cannot be removed
- Clinically significant laboratory abnormalities
- Taking lorazepam over 2 mg daily or any anticonvulsant
- Any condition increasing risk or preventing full study compliance per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
A
Agessandro Abrahao, Dr.
CONTACT
J
Jahan Mookshah
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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