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.

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis (ALS)

Study Type:

Interventional

Type of Intervention:

N/A

Intervention Name:

Transcranial Direct Current Stimulation (tDCS), Sham tDCS + anodal tDCS

Placebo:

Yes

Phase:

N/A

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

Sangeetha Madhavan, University of Illinois at Chicago

Clinicaltrials.gov ID:

NCT04866771

Neals Affiliated?

No

Coordinating Center Contact Information

Brain Plasticity Lab

Sangeetha Madhavan, PT, PhD / email hidden; JavaScript is required / 312-355-2517

Chicago, Illinois, 60305 United States

Study Sponsor:

University of Illinois at Chicago

Estimated Enrollment:

100

Estimated Study Start Date:

08 / 27 / 2021

Estimated Study Completion Date:

12 / 01 / 2023

Posting Last Modified Date:

07 / 07 / 2022

Date Study Added to neals.org:

04 / 30 / 2021

Minimum Age:

18 Years

Maximum Age:

80 Years

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

Brain Plasticity Lab | Recruiting

Sangeetha Madhavan / email hidden; JavaScript is required

Chicago, Illinois 60305
United States