NCT04866771Completed
Remotely Supervised tDCS for Slowing ALS Disease Progression
Remotely Supervised Transcranial Direct Current Stimulation for Slowing Disease Progression in Amyotrophic Lateral Sclerosis (ALS)
Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Most ALS care is centered on patient support and symptom management, making rehabilitation an integral aspect for slowing disease progression, prolonging life span, and increasing quality of life. Brain stimulation has been increasingly explored as a promising neuromodulatory tool to prime motor function in several neurological disorders. We propose a novel mechanism using remotely supervised brain stimulation to preserve motor function in individuals with ALS. This project will also aim to explore the effectiveness of brain stimulation on upper and lower motor neuron mechanisms in individuals with ALS.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 30 Mar 2021
- Start date
- 27 Aug 2021
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- University of Illinois Chicago
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT04866771
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 27 Aug 2021 to the primary completion date, 1 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other concomitant disease that affects prognosis of ALS inclusive of systemic disease, cardiovascular disease, hepatic or renal disorder
- Metal implants in the head or face
Other illness
- Psychiatric disorders
- Implanted cardiac pacemaker
- History of seizures or epilepsy
- Currently under medication that could increase motor excitability and lower seizure threshold
- Skin hypersensitivity
- History of contact dermatitis
- History of allodynia and/or hyperalgesia
- Any other skin or scalp condition that could be aggravated by tDCS
Other
- Subject has bulbar onset ALS
- Any neurological diagnosis other than ALS
- Tracheostomal or noninvasive ventilation for more than 12 hours per day
- Enrollment in an on-going ALS pharmaceutical trial
- Subject plans on moving within 6 months.
- TMS Exclusion Criteria:
- Unexplained, recurring headaches
- Skull abnormalities or fractures
- Concussion within the last 6 months
- Currently pregnant
- tDCS Exclusion Criteria:
Who the study is looking for
- Diagnosis of possible, probable, or definite amyotrophic lateral sclerosis according to El Escorial revised criteria
- Spinal onset ALS with initial weakness in the upper or lower extremity.
- Diagnosed with ALS within the past 5 years
- 1-2 point change in pre-slope of the ALSFRS-R at time of enrollment (ratio of drop in score from 48 to the duration in months from onset of weakness)
- Score ≥ 2 for "swallowing" of the ALSFRS-R
- Score ≥ 2 for "walking" of the ALSFRS-R
- Able to provide informed consent
- Stable dose of riluzole, edaravone, AMX0035 (Relyvrio) or no medications
- Availability of a caregiver for remote administration of tDCS
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brain Plasticity Lab Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.