Status:

COMPLETED

Remotely Supervised tDCS for Slowing ALS Disease Progression

Lead Sponsor:

University of Illinois at Chicago

Collaborating Sponsors:

University of Chicago

Conditions:

Amyotrophic Lateral Sclerosis (ALS)

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

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. Bra...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • Subject has bulbar onset ALS
  • Any neurological diagnosis other than ALS
  • Psychiatric disorders
  • Any other concomitant disease that affects prognosis of ALS inclusive of systemic disease, cardiovascular disease, hepatic or renal disorder
  • 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

Key Trial Info

Start Date :

August 27 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2025

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT04866771

Start Date

August 27 2021

End Date

January 1 2025

Last Update

August 7 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Brain Plasticity Lab

Chicago, Illinois, United States, 60305

Remotely Supervised tDCS for Slowing ALS Disease Progression | DecenTrialz