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Remotely Supervised Transcranial Direct Current Stimulation for Slowing Disease Progression in Amyotrophic Lateral Sclerosis (ALS)

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Sangeetha Madhavan University of Illinois at Chicago

Clinicaltrials.gov ID (11 digit #):

NCT04866771

Neals Affiliated?

No

Coordinating Center Contact Information

Brain Plasticity Lab
Sangeetha Madhavan, PT, PhD / .(JavaScript must be enabled to view this email address) / 312-355-2517
.(JavaScript must be enabled to view this email address) Chicago, Illinois 60305 United States

Full Study Summary:

Study Sponsor:

University of Illinois at Chicago

Participant Duration:

Estimated Enrollment:

100

Estimated Study Start Date:

08/27/2021

Estimated Study Completion Date:

08/31/2024

Posting Last Modified Date:

11/02/2021

Date Study Added to alsconsortium.org:

11/02/2021
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Min Vital Capacity (% predicted normal):

    40

    Time since Symptom Onset:

    Time since Diagnosis:

    <24 months

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    • Diagnosis of 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 24 months
    • 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)
    • Slow vital capacity greater than or equal to 40% of predicted value
    • 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 or edaravone or no medications
    • Availability of a caregiver for remote administration of tDCS

    Exclusion Criteria:

    • 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 3 months.

    TMS Exclusion Criteria:

    • Implanted cardiac pacemaker
    • Metal implants in the head or face
    • Unexplained, recurring headaches
    • History of seizures or epilepsy
    • Currently under medication that could increase motor excitability and lower seizure threshold
    • Skull abnormalities or fractures
    • Concussion within the last 6 months
    • Currently pregnant
    • tDCS Exclusion Criteria:
    • Skin hypersensitivity
    • History of contact dermatitis
    • History of allodynia and/or hyperalgesia
    • Any other skin or scalp condition that could be aggravated by tDCS

  • Site Contact Information

    Brain Plasticity Lab
    Sangeetha Madhavan / .(JavaScript must be enabled to view this email address) / Chicago, Illinois 60305
    United States