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Remotely Supervised tDCS for Slowing ALS Disease Progression

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT04866771
Collaborator
University of Chicago (Other)
100
Enrollment
1
Location
2
Arms
27.1
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Transcranial Direct Current Stimulation (tDCS)
  • Other: Sham tDCS + anodal tDCS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Remotely Supervised Transcranial Direct Current Stimulation for Slowing Disease Progression in Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date :
Aug 27, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transcranial Direct Current Stimulation (tDCS)

Facilitatory transcranial direct current stimulation (tDCS)

Other: Transcranial Direct Current Stimulation (tDCS)
Noninvasive brain stimulation
Other Names:
  • Soterix Medical 1X1 tDCS mini-CT Stimulator

    		•
    Sham Comparator: Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group

    Sham tDCS followed by a switch to anodal tDCS.

    Other: Sham tDCS + anodal tDCS
    Fake noninvasive brain stimulation or anodal noninvasive brain stimulation
    Other Names:
  • Soterix Medical 1X1 tDCS mini-CT Stimulator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Revised ALS Functioning Rating Scale (ALSFRS-R) [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 0-40 with higher scores corresponding to more function being retained.

    2. Muscle Strength Testing [Change from baseline to immediately after training and baseline to 3 months follow up.]

      Maximum strength of bilateral ankle dorsiflexors and knee extensors will be tested using a hand-held dynamometer and using the Medical Research Council (MRC) Scale for muscle strength.

    Secondary Outcome Measures

    1. Gait speed [Change from baseline to immediately after training and baseline to 3 months follow up.]

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

    2. 10-meter walk [Change from baseline to immediately after training and baseline to 3 months follow up.]

      The 10-meter walk test (10MWT) is a performance measure used to assess walking speed in meters per second over a short distance.

    3. Ankle motor control [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.

    4. Quality of Life with EuroQol-5D (EQ-5D) [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.

    5. EuroQual-Visual Analog Scale (EQ-VAS) [Change from baseline to immediately after training and baseline to 3 months follow up.]

      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.

    6. Fatigue Severity Scale [Change from baseline to immediately after training and baseline to 3 months follow up.]

      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.

    7. Upper and lower motor neuron mechanisms using transcranial magnetic stimulation (TMS) [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).

    8. Upper and lower motor neuron mechanisms using peripheral nerve stimulation (PNS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brain Plasticity Lab Chicago Illinois United States 60305

    Sponsors and Collaborators

    • University of Illinois at Chicago
    • University of Chicago

    Investigators

    • Principal Investigator: Sangeetha Madhavan, University of Illinois at Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sangeetha Madhavan, Associate Professor, Physical Therapy, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT04866771
    Other Study ID Numbers:
    • 2021-0097
    First Posted:
    Apr 30, 2021
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis
    Sclerosis
    Disease Progression

    Study Results

    No Results Posted as of Jul 7, 2022