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Procedure
Repetitive TMS for ALS (QuARTS-ALS Trial)
N/A
Recruiting
Led By Agessandro Abrahao, Dr.
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week before, and one and three weeks after ctbs treatment
Awards & highlights
QuARTS-ALS Trial Summary
This trial tests a new treatment for ALS using magnetic stimulation to see if it is safe & effective.
Who is the study for?
This trial is for adults with ALS who can lie down comfortably for an hour, give informed consent, and have been on stable doses of certain ALS medications. They must be able to tolerate TMS procedures and meet specific muscle strength and nerve conduction criteria. People with metal implants in the head/neck, pacemakers, severe claustrophobia, or those on certain medications that affect TMS cannot participate.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a high dose continuous theta-burst stimulation (cTBS) using transcranial magnetic stimulation (TMS) in ALS patients. It's an open-label pilot trial where all participants receive the same treatment without any placebo control.See study design
What are the potential side effects?
Potential side effects from repetitive TMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however these are generally rare. The procedure is non-invasive but requires repeated sessions over time.
QuARTS-ALS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one week before, and one and three weeks after ctbs treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week before, and one and three weeks after ctbs treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Feasibility of cTBS rTMS in patients with ALS
Secondary outcome measures
Corticospinal Excitability change measured by TMS Cortical Silent Period
Corticospinal Excitability change measured by TMS Resting Motor Threshold
Corticospinal Excitability change measured by TMS Short Intracortical Facilitation
+1 moreOther outcome measures
Magnetic Resonance Spectroscopy parameters as measured by 1H-MRS
Neurofilament-light chain levels
QuARTS-ALS Trial Design
1Treatment groups
Experimental Treatment
Group I: Accelerated cTBS NeuromodulationExperimental Treatment1 Intervention
ALS patients receiving an accelerated schedule of continuous theta burst rTMS bilaterally at a regimen of 40 seconds per treatment, for up to 8 treatment sessions per day, delivered one per hour, over 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1170
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,293 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
75 Patients Enrolled for Amyotrophic Lateral Sclerosis
Agessandro Abrahao, Dr.Principal InvestigatorSunnybrook Health Sciences Centre; University of Toronto
Lorne Zinman, Dr.Principal InvestigatorSunnybrook Health Sciences Centre; University of Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with dementia.I have a history of seizures or epilepsy.I am currently taking medication for psychosis or heart rhythm problems.I do not have metal implants in my head or neck, nor do I have a pacemaker, cochlear implants, or a history of epilepsy. Dental fillings are okay.I have been diagnosed with ALS according to the 2020 criteria.I can lie on my back without needing breathing support for at least an hour.I have been on a stable dose of AMX005 for at least 4 weeks.I am 18 years old or older.I have been on a consistent dose of Riluzole for at least 12 weeks.I can undergo TMS (Transcranial Magnetic Stimulation) procedures.My muscle strength is good and my nerve tests show normal signals in my hand.I have completed at least one cycle of Edaravone treatment.I use certain medications as needed, but can follow a fixed dose or stop them for 2 weeks before the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Accelerated cTBS Neuromodulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been admitted to the research project thus far?
"Affirmative. The clinicaltrial.gov database indicates that this medical investigation is currently open for recruitment and was first posted on June 1st 2023 with recent updates occurring on August 8th 2023. This test requires the participation of 15 individuals from a single site."
Answered by AI
Is there still availability for individuals to participate in this research experiment?
"Affirmative. According to information on clinicaltrials.gov, this research trial is actively recruiting participants and was first advertised in June of 2023; the latest update occurred on August 8th, 2023. The aim is to recruit 15 study subjects from one site."
Answered by AI
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