Tests repetitive magnetic brain stimulation in people with ALS

Trial details

Who runs it

Sunnybrook Health Sciences Centre

Trial code

NCT05983211

Record updated

19 September 2024

Original description

Stage 1 [Enrolment closed]:Read full original descriptionShow less

A Biomarker-Directed Neuromodulation Trial Using Quantitative and Repetitive Transcranial Magnetic Stimulation in Amyotrophic Lateral Sclerosis (The QuARTS-ALS Trial)

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.

Inclusion: 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: Lack of MRI brain performed prior to the stage, inability to perform an MRI at baseline due to orthopnea, or:; 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 an intracranial implant or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; 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; Known diagnosis of dementia; History of allergy to Ag-AgCl electrode gel (standard neurophysiology electrodes); 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; 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; have clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians; Definitely or possibly pregnant (if applicable); Unable to tolerate TMS procedures; 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.

ClinicalTrials.gov NCT05983211