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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 up to 30 days before compared to during the initial 5 days of ctbs treatment and up to 24 weeks after
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a high dose magnetic pulse therapy on ALS patients. The therapy uses magnetic fields to stimulate brain areas, which may help improve symptoms like muscle strength and function. Magnetic pulse therapy has been studied for its potential to improve motor function and muscle strength in various neurological conditions, including ALS.

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days before compared to the end of treatment week, 5 weeks, 12 weeks, and 24 weeks after ctbs treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days before compared to the end of treatment week, 5 weeks, 12 weeks, and 24 weeks after ctbs treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Feasibility of cTBS rTMS in patients with ALS
Secondary study objectives
ALSFRS-R scores
Corticospinal Excitability change measured by quantitative TMS
Magnetic Resonance Spectroscopy parameters as measured by MRS
+1 more
Other study objectives
Magnetic Resonance Spectroscopy parameters as measured by 1H-MRS
Neurofilament-light chain levels

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Accelerated cTBS NeuromodulationExperimental Treatment1 Intervention
Stage 2 \[CURRENTLY ENROLLING\]: ALS patients receiving an accelerated schedule of continuous theta burst rTMS bilaterally at multiple M1 regions at a regimen of 40 seconds, 1 minute 20 seconds, 2 minutes, or 4 minutes per treatment for up to 8 treatment sessions per day, delivered one per hour, over 5 days. Additional single-day maintenance treatments will follow these 5 days at a frequency of every 2 weeks for 12 weeks, then every 4 weeks for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1170

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Amyotrophic Lateral Sclerosis (ALS) include neuromodulation techniques like Transcranial Magnetic Stimulation (TMS) and its specific protocol, Continuous Theta-Burst Stimulation (cTBS), which aim to modulate neural activity and induce neuroplastic changes in the motor cortex. This is crucial for ALS patients as it may help slow the progression of motor neuron degeneration. Additionally, antisense oligonucleotides target and reduce the production of abnormal proteins, such as SOD1, that contribute to motor neuron death. Immunomodulatory treatments aim to reduce inflammation and the immune response that exacerbate neuronal damage. These mechanisms are vital as they address different aspects of ALS pathology, potentially improving patient outcomes and quality of life.
Theta-burst Transcranial Magnetic Stimulation Alters the Functional Topography of the Cortical Motor Network.The application of spaced theta burst protocols induces long-lasting neuroplastic changes in the human motor cortex.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
673 Previous Clinical Trials
1,565,852 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

Repetitive Transcranial Magnetic Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05983211 — N/A
Amyotrophic Lateral Sclerosis Research Study Groups: Accelerated cTBS Neuromodulation
Amyotrophic Lateral Sclerosis Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT05983211 — N/A
Repetitive Transcranial Magnetic Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05983211 — N/A
~10 spots leftby Apr 2026