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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
Diagnosed with ALS within the past 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediately after training and baseline to 3 months follow up.
Awards & highlights

Study Summary

This trial will use remotely supervised brain stimulation to attempt to preserve motor function in people with ALS.

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.Check my eligibility
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.See study design
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 was diagnosed with ALS less than 5 years ago.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Muscle Strength Testing
Revised ALS Functioning Rating Scale (ALSFRS-R)
Secondary outcome measures
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
3%
Myasthenia Gravis
3%
back pain flair up
100%
80%
60%
40%
20%
0%
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.

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
601 Previous Clinical Trials
1,558,299 Total Patients Enrolled
University of ChicagoOTHER
995 Previous Clinical Trials
816,568 Total Patients Enrolled
Sangeetha MadhavanPrincipal InvestigatorUniversity of Illinois at Chicago
2 Previous Clinical Trials
181 Total Patients Enrolled

Media Library

tDCS (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04866771 — N/A
Lou Gehrig's Disease Research Study Groups: Transcranial Direct Current Stimulation (tDCS), Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group
Lou Gehrig's Disease Clinical Trial 2023: tDCS Highlights & Side Effects. Trial Name: NCT04866771 — N/A
tDCS (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04866771 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals being recruited for this experiment?

"This clinical trial is only open to patients aged 18-80. For those above 80 or below 18, there are 54 and 464 trials respectively catering to their age range."

Answered by AI

How many participants have been recruited to partake in this clinical experiment?

"That is correct. Information published on clinicaltrials.gov affirms that this trial, initially posted on August 27th 2021, is currently recruiting participants. It aims to enroll 100 patients at a single medical centre."

Answered by AI

To whom does this experiment extend an invitation?

"This double-blind trial is recruiting a cohort of 100 persons with amyotrophic lateral sclerosis aged between 18 and 80. Prospective participants must satisfy the following criteria: A definitive diagnosis according to El Escorial revised guidelines, initial muscular weakness in an upper or lower limb within 24 months prior, 1-2 point drop in ALSFRS-R pre-slope (ratio of decline from 48 to time since onset), slow vital capacity surpassing 40% predicted value, score 2+ for "swallowing" and "walking" on ALSFRS-R scale, willingness to sign informed consent form, prescribed riluzole"

Answered by AI

What are the desired outcomes of this trial?

"This clinical trial seeks to evaluate the Revised ALS Functioning Rating Scale (ALSFRS-R). Secondary objectives include assessing fatigue severity through a 9-item scale, upper and lower motor neuron mechanisms with peripheral nerve stimulation at either the knee or elbow, as well as quality of life via EuroQol-5D (EQ-5D) questionnaires. The overall duration is Change from baseline to immediately after training and baseline to 3 months follow up.."

Answered by AI

Are there still vacancies for participants in this research?

"Indeed, the details on clinicaltrials.gov verify that this experiment is actively enlisting patients. It was initially posted in August 27th 2021 and last updated July 6th 2022; 100 individuals are expected to join from 1 site."

Answered by AI
~11 spots leftby Aug 2024