Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Fort Collins, Colorado, United States, 80523
- Department of Health and Exercise Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medically diagnosed with MS
- Moderate disability (Patient Determined Disease Steps score 2-6)
- Self-reported differences in function between the legs (2-5 on a 1-5 scale)
- People with MS with physician clearance
Exclusion Criteria:
- A relapse of disease symptoms in the last 60 days
- A condition unrelated to MS that would exacerbate fatigue, such as anemia, hypothyroidism, shiftwork-related fatigue, B12 deficiency, major sleep disorder, or major depressive disorder
- Medical diagnosis or condition that makes participating in exercise training dangerous, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
- History of heart attack or current diagnosis of cardiovascular disease
- History of seizure disorders (or on medications known to lower seizure threshold), hydrocephalus (buildup of fluid in the brain), or diabetes
- Alcohol dependence or abuse (>2 drinks/day), or present history (last six months) of drug abuse
- History of significant traumatic brain injury or hydrocephalus
- Pregnancy
- Recent hospitalization (within the last 3 months) or enforced bed rest/sedentary state.
- Presence of metal is present or implanted device or metal object that is not safe for TMS.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Sham first, wash out 7 days, then tDCS
Separated by a minimum of 7 days from the sham treatment in a counterbalance order, all participants will perform leg muscle strength and fatigue testing once with tDCS stimulation. Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Sham: Less than 0V of Transcranial Direct Current Stimulation tDCS: Less than 10V of Transcranial Direct Current Stimulation |
Less than 10V of Transcranial Direct Current Stimulation.
Sham 0V of Transcranial Direct Current Stimulation.
Other Names:
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Experimental: tDCS first, wash out 7 days, then Sham
Separated by a minimum of 7 days from the sham treatment in a counterbalance order, all participants will perform leg muscle strength and fatigue testing once with tDCS stimulation. Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Sham: Less than 0V of Transcranial Direct Current Stimulation tDCS: Less than 10V of Transcranial Direct Current Stimulation |
Less than 10V of Transcranial Direct Current Stimulation.
Sham 0V of Transcranial Direct Current Stimulation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Leg Muscle Strength With and Without tDCS.
Time Frame: At session 1 and minimum of 7 days later
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Knee extensor strength will be tested with tDCS (less than 10V) and sham stimulation (0V). Participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC. During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds. |
At session 1 and minimum of 7 days later
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Leg Muscle Endurance With and Without tDCS.
Time Frame: At session 1 and minimum of 7 days later.
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Knee extensor endurance (fatigue) will be tested with tDCS (less than 10V) and sham stimulation (0V), as reported as time to failure. During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second prior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds. |
At session 1 and minimum of 7 days later.
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6 Minute Walk Test
Time Frame: At session 1 and minimum of 7 days later
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After completion of the tDCS/Sham strength assessment participants will perform a 6 minute walk test.
The test will be performed in a cordoned off hallway with 2 cones placed 30 meters apart.
Once the participants begin walking, a timer will be started and the distance covered every min will be recorded.
Participants are allowed to stop and rest during the test if required.
Every minute during the walk test participants will be asked their rating of perceived exertion (RPE, 0-10 scale).
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At session 1 and minimum of 7 days later
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-6856H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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