Remotely Supervised tDCS for Slowing ALS Disease Progression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-27

Study Completion Date

2025-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis (ALS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Transcranial Direct Current Stimulation (tDCS)

Facilitatory transcranial direct current stimulation (tDCS)

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type OTHER

Noninvasive brain stimulation

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

Sham tDCS followed by a switch to anodal tDCS.

Group Type SHAM_COMPARATOR

Sham tDCS + anodal tDCS

Intervention Type OTHER

Fake noninvasive brain stimulation or anodal noninvasive brain stimulation

Interventions

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Transcranial Direct Current Stimulation (tDCS)

Noninvasive brain stimulation

Intervention Type OTHER

Sham tDCS + anodal tDCS

Fake noninvasive brain stimulation or anodal noninvasive brain stimulation

Intervention Type OTHER

Other Intervention Names

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Soterix Medical 1X1 tDCS mini-CT Stimulator Soterix Medical 1X1 tDCS mini-CT Stimulator

Eligibility Criteria

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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.

* 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
* Skin hypersensitivity
* History of contact dermatitis
* History of allodynia and/or hyperalgesia
* Any other skin or scalp condition that could be aggravated by tDCS

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No