- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04866771
Remotely Supervised tDCS for Slowing ALS Disease Progression
October 9, 2023 updated by: Sangeetha Madhavan, University of Illinois at Chicago
Remotely Supervised Transcranial Direct Current Stimulation for Slowing Disease Progression in Amyotrophic Lateral Sclerosis (ALS)
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sangeetha Madhavan, PT, PhD
- Phone Number: 312-355-2517
- Email: smadhava@uic.edu
Study Locations
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Illinois
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Chicago, Illinois, United States, 60305
- Brain Plasticity Lab
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcranial Direct Current Stimulation (tDCS)
Facilitatory transcranial direct current stimulation (tDCS)
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Noninvasive brain stimulation
Other Names:
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Sham Comparator: Delayed-Start Transcranial Direct Current Stimulation (tDCS) Control Group
Sham tDCS followed by a switch to anodal tDCS.
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Fake noninvasive brain stimulation or anodal noninvasive brain stimulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised ALS Functioning Rating Scale (ALSFRS-R)
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
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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.
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Change from baseline to immediately after training and baseline to 3 months follow up.
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Muscle Strength Testing
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
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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.
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Change from baseline to immediately after training and baseline to 3 months follow up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait speed
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
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Self-selected and fast walking will be measured as the average walking speed from 2 trials of the 10-m walk test (10MWT).
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Change from baseline to immediately after training and baseline to 3 months follow up.
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10-meter walk
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
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The 10-meter walk test (10MWT) is a performance measure used to assess walking speed in meters per second over a short distance.
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Change from baseline to immediately after training and baseline to 3 months follow up.
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Ankle motor control
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
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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.
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Change from baseline to immediately after training and baseline to 3 months follow up.
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Quality of Life with EuroQol-5D (EQ-5D)
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
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Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.
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Change from baseline to immediately after training and baseline to 3 months follow up.
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EuroQual-Visual Analog Scale (EQ-VAS)
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
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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.
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Change from baseline to immediately after training and baseline to 3 months follow up.
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Fatigue Severity Scale
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
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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.
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Change from baseline to immediately after training and baseline to 3 months follow up.
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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.
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Upper and lower motor neuron mechanisms of the tibialis anterior will be measured using single pulse transcranial magnetic stimulation (TMS).
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Change from baseline to immediately after training and baseline to 3 months follow up.
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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.
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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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Change from baseline to immediately after training and baseline to 3 months follow up.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sangeetha Madhavan, University of Illinois at Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2021
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
March 30, 2021
First Submitted That Met QC Criteria
April 26, 2021
First Posted (Actual)
April 30, 2021
Study Record Updates
Last Update Posted (Estimated)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 9, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease Attributes
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Sclerosis
- Disease Progression
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
Other Study ID Numbers
- 2021-0097
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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