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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sangeetha Madhavan

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+