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Completed

NCT Number: NCT04866771

Remotely Supervised tDCS for Slowing ALS Disease Progression

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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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Plasticity Lab

Chicago, Illinois, 60305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Other

Noninvasive brain stimulation

Other names: Soterix Medical 1X1 tDCS mini-CT Stimulator

Sham tDCS + anodal tDCS

Other

Fake noninvasive brain stimulation or anodal noninvasive brain stimulation

Other names: Soterix Medical 1X1 tDCS mini-CT Stimulator

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Gait Speed

    Time frame: Change from baseline to immediately after training

    Self-selected will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT).

  2. Ankle Motor Control

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

    The participant will track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Accuracy of tracking the target with ankle motion will be calculated.

  3. Quality of Life With EuroQol-5D (EQ-5D)

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

    Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.

  4. EuroQual-Visual Analog Scale (EQ-VAS)

    Time frame: Change from baseline to immediately after training

    Quality of life will be measured using a visual analog scale with endpoints labeled, 'The best health you can imagine' and 'the worst health you can imagine' in response to questions related to aspects of quality of life. Scores range from 0 to 100, with higher values indicating better self-rated health status."

  5. Fatigue Severity Scale

    Time frame: Change from baseline to immediately after training.

    9-item scale measuring severity of fatigue and its effect on participant's daily activities and lifestyle with higher scores representing more fatigue and fatigue playing a larger role in daily activities. Minimum score = 0 and maximum score = 63.

  6. Upper and Lower Motor Neuron Mechanisms Using Transcranial Magnetic Stimulation (TMS)

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

    Upper and lower motor neuron mechanisms of the tibialis anterior will be measured using single pulse transcranial magnetic stimulation (TMS). Measures may include motor evoked potential (MEP) amplitude, latency, and/or cortical silent period.

  7. Upper and Lower Motor Neuron Mechanisms Using Peripheral Nerve Stimulation (PNS)

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

    Upper and lower motor neuron mechanisms in ALS will also be assessed using peripheral nerve stimulation at either the knee or the elbow.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Apr 30, 2021
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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