Quantitative and Repetitive TMS in ALS - Recruiting for Stage 2

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation 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.