Testing Repetitive Transcranial Magnetic for amyotrophic lateral sclerosis
Official title: Quantitative and Repetitive TMS in ALS - Recruiting for Stage 2
A Biomarker-Directed Neuromodulation Trial Using Quantitative and Repetitive Transcranial Magnetic Stimulation in Amyotrophic Lateral Sclerosis (The QuARTS-ALS Trial)
Interventions
Repetitive Transcranial Magnetic Stimulation
Stage 2 \[CURRENTLY ENROLLING\]: Accelerated rTMS using continuous theta burst stimulation (cTBS) inhibitory paradigms over bilateral M1 including hand, leg, and bulbar regions outputted at 90% of resting motor threshold, using bursts of 3 pulses at 50 Hz. Bursts are repeated at 5 Hz for a total of 600, 1200, 1800, or 3600 pulses over 40 seconds, 1 minute 20 seconds, 2 minutes, or 4 minutes. ALS patients will receive rTMS bilaterally for up to 8 treatment sessions per day, delivered one per hour, over 5 days, followed by single-day maintenance treatments at a frequency of every 2 weeks for 12 weeks, then every 4 weeks for 12 weeks.
Canadian Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years;
- +Diagnosis with ALS as per the 2020 Gold Coast Criteria;
- +Able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to study procedures and treatments;
- +Patients are allowed to start or continue the standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → 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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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 VisitBaselineYour starting measurements, taken before treatment begins.Read more → or after a wash-outWashout periodA gap with no treatment, so the previous one clears your system.Read more → 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
- −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;
- −Known diagnosis of dementia;
- −Unable to tolerate TMS procedures;
- −Lack of MRI brain performed prior to the stage, inability to perform an MRI at baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 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 SiteTrial siteA hospital or clinic where a study is actually run.Read more → InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would place the subject at increased risk or preclude the subject's full compliance with completion of the stage.
- −Definitely or possibly pregnant (if applicable);
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Repetitive Transcranial Magnetic Stimulation.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 15 people.
The study is currently expected to finish around April 2027.
The main measurement is taken over: Up to 30 days before compared to during the initial 5 days of cTBS treatment and up to 24 weeks after.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Safety and Feasibility of cTBS rTMS in patients with ALS — measured over Up to 30 days before compared to during the initial 5 days of cTBS treatment and up to 24 weeks after.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05983211 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Repetitive Transcranial Magnetic StimulationDevice
Stage 2 \[CURRENTLY ENROLLING\]: Accelerated rTMS using continuous theta burst stimulation (cTBS) inhibitory paradigms over bilateral M1 including hand, leg, and bulbar regions outputted at 90% of resting motor threshold, using bursts of 3 pulses at 50 Hz. Bursts are repeated at 5 Hz for a total of 600, 1200, 1800, or 3600 pulses over 40 seconds, 1 minute 20 seconds, 2 minutes, or 4 minutes. ALS patients will receive rTMS bilaterally for up to 8 treatment sessions per day, delivered one per hour, over 5 days, followed by single-day maintenance treatments at a frequency of every 2 weeks for 12 weeks, then every 4 weeks for 12 weeks.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 30 days before compared to during the initial 5 days of cTBS treatment and up to 24 weeks after.
The study as a whole is currently expected to finish around 2027-04-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 15 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This 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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.