NCT05983211 Quantitative and Repetitive TMS in ALS - Recruiting for Stage 2
| NCT ID | NCT05983211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-05-01 with a primary completion date of 2026-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis with ALS as per the 2020 Gold Coast Criteria; * Age ≥ 18 years; * Able to provide informed consent to study procedures and treatments; * Patients are allowed to start or continue the standard of care treatments for ALS. Presently these include oral riluzole, and oral or intravenous edaravone; * Able to lie supine without BiPAP or breathing discomfort for at least 1 hour; * No contraindications to TMS as follow; * Metal implants in the head or neck (such as aneurysm clips, vessel stents), implanted medication pump, implanted brain stimulators, pacemaker, cochlear implants, or history of epilepsy. Dental fillings are permitted; * Current use of medications or medical conditions that, at the discretion of the Principal Investigator, could potentially increase the risk of seizures or interfere with stage outcomes; * On medications that affect TMS measures in a PRN regimen (as needed). Continuous use of these medications on a fixed dose of 30 days prior to first Baseline Visit or after a wash-out period of 2 weeks is accepted. These medications include, but are not limited to: benzodiazepines, muscle relaxants, tricyclic antidepressants, selective and non-selective serotonin reuptake inhibitors, hypnotics (including anti-histamine drugs) and anticholinergics drugs; * History of seizure, convulsion, or epilepsy; Exclusion Criteria: * Known diagnosis of dementia; * Definitely or possibly pregnant (if applicable); * History of allergy to Ag-AgCl electrode gel (standard neurophysiology electrodes); * Unable to tolerate TMS procedures; * Lack of MRI brain performed prior to the stage, inability to perform an MRI at baseline due to orthopnea, or: * Large body habitus and not fitting comfortably into the scanner; * Difficulty laying still for up to 1 hour in the MRI unit or significant claustrophobia; * Metallic implants; * Any contraindications for receiving rTMS treatment as follow: * have received rTMS for any previous indication due to the potential compromise of subject blinding; * have increased intracranial pressure, a space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy, significant head trauma with clear radiological evidence of cerebrovascular injury on imaging; * have an intracranial implant or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; * have clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians; * are currently taking more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy; * Any other clinical condition that, in the opinion of the Site Investigator, would place the subject at increased risk or preclude the subject's full compliance with completion of the stage.
Contact & Investigator
Agessandro Abrahao, Dr.
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre; University of Toronto
Frequently Asked Questions
Who can join the NCT05983211 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05983211 currently recruiting?
Yes, NCT05983211 is actively recruiting participants. Contact the research team at alsresearch@sunnybrook.ca for enrollment information.
Where is the NCT05983211 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05983211 clinical trial?
NCT05983211 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Agessandro Abrahao, Dr. at Sunnybrook Health Sciences Centre; University of Toronto. The trial plans to enroll 15 participants.
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