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New treatment option for Amyotrophic Lateral Sclerosis
Official title Quantitative and Repetitive TMS in ALS - Recruiting for Stage 2
ClinicalTrials.gov ID: NCT05983211
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Able to lie supine without BiPAP or breathing discomfort for at least 1 hour;
You likely can't join if
- 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;
See the full eligibility 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...
- History of seizure, convulsion, or epilepsy;
- 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...
- 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 how well it works;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.