Remotely Supervised tDCS for Slowing ALS Disease Progression

NCT04866771 | Completed Results DMC

• 1 other identifier: 2021-0097
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

• Change in Revised ALS Functioning Rating Scale (ALSFRS-R)

  This questionnaire evaluates function over time and disease progression in ALS patients with questions related to daily activities such as speech, swallowing, walking, etc. Scores range between 0-48 with higher scores corresponding to more function being retained.

  Change from baseline to immediately after training and baseline to 3 months follow up.

Secondary Outcomes (7)

• Gait Speed

  Change from baseline to immediately after training

• Ankle Motor Control

  Change from baseline to immediately after training and baseline to 3 months follow up.

• Quality of Life With EuroQol-5D (EQ-5D)

  Change from baseline to immediately after training and baseline to 3 months follow up.

• EuroQual-Visual Analog Scale (EQ-VAS)

  Change from baseline to immediately after training

• Fatigue Severity Scale

  Change from baseline to immediately after training.

Study Arms (2)

Transcranial Direct Current Stimulation (tDCS)

EXPERIMENTAL

Facilitatory transcranial direct current stimulation (tDCS)

Other: Transcranial Direct Current Stimulation (tDCS)

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

SHAM COMPARATOR

Sham tDCS followed by a switch to anodal tDCS.

Other: Sham tDCS + anodal tDCS

Interventions

Transcranial Direct Current Stimulation (tDCS) OTHER

Noninvasive brain stimulation

Also known as: Soterix Medical 1X1 tDCS mini-CT Stimulator

Transcranial Direct Current Stimulation (tDCS)

Sham tDCS + anodal tDCS OTHER

Fake noninvasive brain stimulation or anodal noninvasive brain stimulation

Also known as: Soterix Medical 1X1 tDCS mini-CT Stimulator

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• University of Chicago: collaborator

Study Sites (1)

Brain Plasticity Lab

Chicago, Illinois, 60305, United States

Location

Related Publications (1)

• Madhavan S, Deshmukh S, Cummings M, Doshi A, Rezania K, Freels S, Sawa G. Home-Based Tele-tDCS in Amyotrophic Lateral Sclerosis: Feasibility, Safety, and Preliminary Efficacy. Ann Clin Transl Neurol. 2025 May;12(5):1022-1033. doi: 10.1002/acn3.70038. Epub 2025 Mar 24.

  PMID: 40125702 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: PRS Training Lead
• Organization: University Of Illinois At Chicago

awards@uic.edu

(312) 996-4995

Study Officials

• Sangeetha Madhavan

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Physical Therapy

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 30, 2021
• Study Start: August 27, 2021
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)