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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham first, wash out 7 days, then tDCS | Experimental | 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 |
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| tDCS first, wash out 7 days, then Sham | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At session 1 and minimum of 7 days later |
| 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. | At session 1 and minimum of 7 days later. |
| 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). | At session 1 and minimum of 7 days later |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Health and Exercise Science | Fort Collins | Colorado | 80523 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham First, Seven Day Wash Out, Then tDCS | Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order. Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted. The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors. tDCS: Less than 10V of Transcranial Direct Current Stimulation Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation |
| FG001 | tDCS First, 7 Day Wash Out, Then Sham | Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order. Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted. The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors. tDCS: Less than 10V of Transcranial Direct Current Stimulation Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Crossover study
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Separated by a minimum of 7 days, participants will perform leg muscle strength and fatigue testing once with tDCS and once with Sham in a counterbalanced order. Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Note: the 6 minute walk test was not conducted. The fatigue testing will be measured by time to fatigue with isometric contraction of the knee extensors. tDCS: Less than 10V of Transcranial Direct Current Stimulation Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Crossover design | Posted | Mean | Standard Error | Newtons | At session 1 and minimum of 7 days later |
|
Adverse events were determined at session 1 and minimum of 7 days later at session 2. No adverse events were reported by participants.
The six minute walk test was not performed and therefore no participants were at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants-Leg Muscle Strength tDCS | Knee extensor strength was tested for all study participants with tDCS (less than 10V). All study 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Research Operations | Colorado State University | 9704912242 | Laurie.Biela@colostate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 24, 2017 | Apr 8, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Participants will perform leg muscle strength testing with tDCS. On a separate day they will repeat the leg muscle strength testing with Sham stimulation.
Leg strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials. Furthermore, participants perform a 6 minute walk.
tDCS: Less than 10V of Transcranial Direct Current Stimulation
Sham tDCS: Sham 0V of Transcranial Direct Current Stimulation
|
|
| Primary | 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. | Crossover design | Posted | Mean | Standard Error | seconds | At session 1 and minimum of 7 days later. |
|
|
|
| Primary | 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). | No data was collected | Posted | At session 1 and minimum of 7 days later |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | All Study Participants-Leg Muscle Strength Sham | Knee extensor strength was tested for all study participants with sham stimulation (0V). All study 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. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds and extended until task failure or a maximum length of 20 minutes. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | All Study Participants-Leg Muscle Endurance tDCS | Knee extensor endurance (fatigue) was tested for all participants with tDCS (less than 10V) 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | All Study Participants-Leg Muscle Endurance Sham | Knee extensor endurance (fatigue) was tested for all participants with sham stimulation (0V) as reported as time to failure. The current was ramped up to 2 mA, but turned off after 30 seconds until task failure or a maximum length of 20 minutes. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |