Remotely Supervised tDCS for Slowing ALS Disease Progression

University of Illinois

Status: Active, not recruiting

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Other: Transcranial Direct Current Stimulation (tDCS); Other: Sham tDCS + anodal tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04866771

2021-0097

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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 6 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Transcranial Direct Current Stimulation (tDCS)

Experimental group

Description:

Facilitatory transcranial direct current stimulation (tDCS)

Treatment:

Other: Transcranial Direct Current Stimulation (tDCS)

Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group

Sham Comparator group

Description:

Sham tDCS followed by a switch to anodal tDCS.

Treatment:

Other: Sham tDCS + anodal tDCS