tDCS for Slowing ALS Progression

Overseen By Sangeetha Madhavan, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must be taking: Riluzole, Edaravone, Relyvrio

Must not be taking: Seizure threshold reducers

Disqualifiers: Bulbar ALS, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with ALS, a disease affecting nerves and muscles, through brain stimulation. The treatment, called Transcranial Direct Current Stimulation (tDCS), uses a gentle electrical current applied to the scalp to preserve muscle function. It targets those diagnosed with ALS in the last five years, particularly if they began with weakness in their arms or legs. Participants must have a caregiver available for the remote part of the treatment. The trial aims to determine if tDCS can slow ALS progression and improve daily life. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance ALS treatment options.

Do I have to stop taking my current medications for the trial?

The trial requires that participants either have a stable dose of riluzole, edaravone, AMX0035 (Relyvrio), or be on no medications. If you are on other medications, the protocol does not specify if you need to stop them.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for ALS patients?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated for people with ALS. Studies have found that tele-tDCS, which involves remote treatment at home, is both practical and safe. Participants did not report any serious side effects.

One study highlighted that tDCS can be used safely for long periods without major problems. Another study confirmed that tDCS is a non-invasive brain stimulation tool, meaning it doesn't require surgery, which enhances its safety.

Overall, tDCS appears to be a safe option for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for ALS, which often include medications like Riluzole and Edaravone that work to slow disease progression by reducing damage to motor neurons, transcranial direct current stimulation (tDCS) offers a non-invasive approach. tDCS uses electrical currents to stimulate specific parts of the brain, potentially enhancing neural activity and function without the need for drugs. Researchers are excited about tDCS because it represents a new mechanism of action that could complement existing therapies, possibly leading to improved quality of life for patients with ALS. Additionally, the tDCS approach is appealing because it may have fewer side effects compared to systemic medications.

What evidence suggests that tDCS is effective for slowing ALS progression?

Research shows that transcranial direct current stimulation (tDCS) might help people with ALS. Studies have found that tDCS can strengthen patients, ease caregivers' workload, and improve patients' quality of life. Early results also suggest that tDCS might slow the disease's progression. In this trial, participants will receive either immediate anodal tDCS or begin with sham tDCS before switching to anodal tDCS. Anodal tDCS has helped without worsening ALS. Overall, tDCS is considered a promising and non-invasive treatment option for people with ALS. ^{1 4 5 6 7}

Who Is on the Research Team?

Sangeetha Madhavan

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your ALSFRS-R score has changed by 1-2 points before joining the study.

Availability of a caregiver for remote administration of tDCS

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

Exclusion Criteria

You have mental health conditions.

I do not have any other serious illnesses that could affect my ALS outcome.

My neurological condition is not ALS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remotely supervised transcranial direct current stimulation (tDCS) to preserve motor function

3 months

Remote supervision

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview 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.

How Is the Trial Designed?

Group I: Transcranial Direct Current Stimulation (tDCS) Experimental Treatment 1 Intervention

Facilitatory transcranial direct current stimulation (tDCS)

Group II: Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group Placebo Group 1 Intervention

Sham tDCS followed by a switch to anodal tDCS.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12093353/

Home‐Based Tele‐tDCS in Amyotrophic Lateral Sclerosis Tele‐tDCS was feasible, safe, and well‐tolerated in individuals with ALS. Preliminary efficacy results suggest that tele‐tDCS may slow disease ...

2. mdpi.com mdpi.com/2077-0383/14/19/6701

High-Definition Transcranial Direct Current Stimulation (HD ... Evidence suggests that anodal tDCS, unlike cathodal tDCS, can induce beneficial functional effects without accelerating the progression of Amyotrophic Lateral ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X23019514

Cortico-spinal tDCS in amyotrophic lateral sclerosis Compared to sham stimulation, cortico-spinal tDCS significantly improved global strength, caregiver burden, and quality of life scores, which correlated with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07006571

At-home Treatment With Cortico-spinal tDCS for ... A promising non-invasive treatment called transcranial direct current stimulation (tDCS) has shown potential benefits for patients with ALS. tDCS involves ...

5. archives-pmr.org archives-pmr.org/article/S0003-9993(16)30561-5/fulltext

Transcranial Direct Current Stimulation For Amyotrophic ... The primary outcome was corticomotor excitability of the upper and lower limb M1 as measured with single pulse transcranial magnetic stimulation (TMS).

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29488820/

a pilot study with a single subject experimental design This case study demonstrates the safety and feasibility of long-term facilitatory and inhibitory tDCS on a single participant with ALS.

7. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(24)00626-0/fulltext

Safety and feasibility of tele-tDCS for slowing disease ... This study supports tele-tDCS as a safe, feasible home-based intervention for ALS, highlighting its potential to reduce logistical and physical demands on ...