What is the mechanism of action of this treatment?

The most common treatments for Lou Gehrig's Disease (ALS) focus on symptom management and slowing disease progression. One promising approach is neuromodulation, such as remotely supervised brain stimulation, which aims to preserve motor function by stimulating specific brain regions to enhance motor neuron activity. This technique can potentially slow the degeneration of motor neurons, thereby maintaining muscle function and prolonging the patient's ability to perform daily activities. This is crucial for ALS patients as it can improve their quality of life and extend their functional independence.

What side effects are associated with this type of intervention?

Common treatments for ALS include medications like riluzole and edaravone, which can cause side effects such as nausea, fatigue, and liver function abnormalities. Neuromodulation techniques, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), are being explored to preserve motor function. These treatments are generally well-tolerated but can cause mild side effects like headaches, scalp discomfort, and dizziness. Vagus nerve stimulation (VNS) is another neuromodulation approach that may lead to voice changes, throat pain, and shortness of breath. Overall, while these treatments offer potential benefits, they come with manageable side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Lou Gehrig's Disease (ALS), including riluzole and edaravone, which aim to slow disease progression. Riluzole is believed to reduce damage to motor neurons by decreasing the release of glutamate. Edaravone is an antioxidant that may help reduce oxidative stress in neurons. While these drugs are not directly related to neuromodulation, ongoing research, such as the trial on Remotely Supervised Brain Stimulation, explores innovative approaches to preserve motor function in ALS patients.

What other types of research exist?

Promising novel alternatives to Remotely Supervised Brain Stimulation for ALS patients include: 1) Antisense Oligonucleotide Therapy, specifically Tofersen for SOD1 ALS, which has shown potential in clinical trials. 2) Gene Therapy using Adeno-Associated Virus and MicroRNA for SOD1 suppression in familial ALS. 3) Disease-modifying treatments like AMX0035, which have shown long-term benefits in clinical trials. These alternatives are at the forefront of ALS research and may offer new hope for patients in 2024.

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Brain Stimulation

tDCS for Slowing ALS Progression

N/A

Waitlist Available

Led By Sangeetha Madhavan

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable dose of riluzole, edaravone, AMX0035 (Relyvrio) or no medications

Diagnosis of possible, probable, or definite amyotrophic lateral sclerosis according to El Escorial revised criteria

Must not have

Any neurological diagnosis other than ALS

Tracheostomal or noninvasive ventilation for more than 12 hours per day

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to immediately after training and baseline to 3 months follow up.

Summary

This trial is testing a new treatment that uses electrical signals sent to the brain, monitored by doctors remotely. It aims to help people with ALS keep their muscles working better for longer. The goal is to see if this method can slow down the loss of motor function in ALS patients.

Who is the study for?

This trial is for individuals diagnosed with ALS within the last 5 years, who can swallow and walk to some extent, are on a stable dose of certain ALS medications or none, and have a caregiver available. It's not for those with other neurological diseases, severe psychiatric disorders, serious systemic illnesses, or those using ventilation over 12 hours daily.

What is being tested?

The study tests remotely supervised brain stimulation (tDCS) as a potential treatment to slow down ALS progression. Participants will receive either actual tDCS or sham (fake) therapy to see if it helps maintain motor functions better than no treatment.

What are the potential side effects?

While tDCS is generally considered safe, possible side effects include mild itching, tingling at the electrode sites during application, headache after sessions and fatigue. Serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on a stable dose of ALS medication or not taking any.

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I have been diagnosed with ALS.

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I can walk with some assistance.

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My ALS started with weakness in my arms or legs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My neurological condition is not ALS.

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I use a ventilator for more than 12 hours daily.

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My ALS started with speech or swallowing problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to immediately after training and baseline to 3 months follow up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to immediately after training and baseline to 3 months follow up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to immediately after training and baseline to 3 months follow up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Muscle Strength Testing

Revised ALS Functioning Rating Scale (ALSFRS-R)

Secondary study objectives

10-meter walk

Ankle motor control

EuroQual-Visual Analog Scale (EQ-VAS)

+5 more

Side effects data

From 2018 Phase 2 trial • 54 Patients • NCT01726673

back pain flair up

Myasthenia Gravis

100%

80%

60%

40%

20%

Study treatment Arm

tDCS + Robotic Arm Therapy

tDCS Sham + Robotic Arm Therapy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcranial Direct Current Stimulation (tDCS)Experimental Treatment1 Intervention

Facilitatory transcranial direct current stimulation (tDCS)

Group II: Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control GroupPlacebo Group1 Intervention

Sham tDCS followed by a switch to anodal tDCS.

0 / 7Eligibility criteria met

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 Lou Gehrig's Disease (ALS) focus on symptom management and slowing disease progression. One promising approach is neuromodulation, such as remotely supervised brain stimulation, which aims to preserve motor function by stimulating specific brain regions to enhance motor neuron activity. This technique can potentially slow the degeneration of motor neurons, thereby maintaining muscle function and prolonging the patient's ability to perform daily activities. This is crucial for ALS patients as it can improve their quality of life and extend their functional independence.