What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Treatments for Amyotrophic Lateral Sclerosis (ALS) using Transcranial Magnetic Stimulation (TMS), including Accelerated, High Dose Continuous Theta-Burst Stimulation (cTBS), are generally well-tolerated. Common side effects include mild headaches, scalp discomfort at the stimulation site, and tingling or twitching of facial muscles. Serious side effects are rare but can include seizures, especially in individuals with a history of epilepsy.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Amyotrophic Lateral Sclerosis (ALS), including Riluzole and Edaravone. Riluzole is believed to reduce damage to motor neurons by decreasing the release of glutamate, while Edaravone is thought to act as an antioxidant, reducing oxidative stress. While these drugs focus on neuroprotection and reducing neuronal damage, they do not involve neuromodulation techniques like Transcranial Magnetic Stimulation (TMS). TMS, including protocols like continuous theta-burst stimulation (cTBS), is being studied for its potential to modulate neural activity and induce neuroplastic changes, but it is not yet an FDA-approved treatment for ALS.

What other types of research exist?

Promising novel alternatives to cTBS using TMS for ALS patients include: 1) Vagus Nerve Stimulation (VNS), which has shown potential in treatment-resistant depression and may offer benefits for ALS; 2) Deep Brain Stimulation (DBS), an invasive technique that modulates neural activity and is being explored for various neurological conditions; 3) Transcranial Direct-Current Stimulation (tDCS), a noninvasive method that has shown promise in enhancing neurocognition and mood in bipolar patients and may be applicable to ALS; 4) Magnetic Seizure Therapy (MST), an investigational procedure that combines aspects of ECT and TMS and may offer therapeutic benefits for neurodegenerative diseases.

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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 weeks3 visits

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

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

Do I qualify?Apply below to find out

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.