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Remotely Supervised tDCS for Slowing ALS Disease Progression

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ClinicalTrials.gov Identifier: NCT04866771
Recruitment Status : Not yet recruiting
First Posted : April 30, 2021
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Sangeetha Madhavan, University of Illinois at Chicago

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
Amyotrophic Lateral Sclerosis (ALS) Other: Transcranial Direct Current Stimulation (tDCS) Other: Sham tDCS + anodal tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024


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




Primary Outcome Measures :
  1. 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 0-40 with higher scores corresponding to more function being retained.

  2. Muscle Strength Testing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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.

  4. 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.

  5. EuroQual-Visual Analog Scale (EQ-VAS) [ Time Frame: 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 [ Time Frame: 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) [ 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).

  8. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866771


Contacts
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Contact: Sangeetha Madhavan, PT, PhD 312-355-2517 smadhava@uic.edu

Sponsors and Collaborators
University of Illinois at Chicago
University of Chicago
Investigators
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Principal Investigator: Sangeetha Madhavan University of Illinois at Chicago
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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: April 30, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Disease Progression
Pathologic Processes
Disease Attributes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases