Quantitative and Repetitive TMS in ALS - Recruiting for Stage 2 (NCT05983211) | Clinical Trial Compass
RecruitingNot Applicable
Quantitative and Repetitive TMS in ALS - Recruiting for Stage 2
Canada15 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ele…
What they're measuring
1
Safety and Feasibility of cTBS rTMS in patients with ALS
Timeframe: Up to 30 days before compared to during the initial 5 days of cTBS treatment and up to 24 weeks after