Back to resultsCan Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional basic science trial for Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Department of Health and Exercise Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sham first, wash out 7 days, then tDCS
tDCS first, wash out 7 days, then Sham
Arm Description
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
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
Outcomes
Primary Outcome Measures
Leg Muscle Strength With and Without tDCS.
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.
Leg Muscle Endurance With and Without tDCS.
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.
6 Minute Walk Test
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02987621
First Posted
December 5, 2016
Last Updated
July 15, 2020
Sponsor
Colorado State University
1. Study Identification
Unique Protocol Identification Number
NCT02987621
Brief Title
Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
Official Title
Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this project the investigators will be using non-invasive brain stimulation on people with multiple sclerosis (PwMS) to improve leg muscle function. Two groups of participants will be recruited. One group will perform strength testing with and without the brain stimulation. The second group of participants will perform a fatigue task, pulling against a wire at a low level of force, with and without the brain stimulation. This type of brain stimulation has been shown to transiently improve strength and fatigue measures in other populations, e.g. aged, Parkinson's, and improve cognitive abilities in people with multiple sclerosis. It is the investigator's hope that the increases in performance seen in other patient groups will also occur in people with multiple sclerosis. Future investigations will look to apply the non-invasive brain stimulation technique during physical rehabilitation to improve short and long term outcomes related to physical function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham first, wash out 7 days, then tDCS
Arm Type
Experimental
Arm Description
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
Arm Title
tDCS first, wash out 7 days, then Sham
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
The Travel Model v2.0 Advanced tDCS Kit, The Brian Simulator
Intervention Description
Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation.
Primary Outcome Measure Information:
Title
Leg Muscle Strength With and Without tDCS.
Description
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.
Time Frame
At session 1 and minimum of 7 days later
Title
Leg Muscle Endurance With and Without tDCS.
Description
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.
Time Frame
At session 1 and minimum of 7 days later.
Title
6 Minute Walk Test
Description
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).
Time Frame
At session 1 and minimum of 7 days later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Health and Exercise Science
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
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