Multiple SclerosisNCT02987621
Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
A study testing tDCS in people with Multiple Sclerosis, run by Colorado State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Exercise Science
Fort Collins, Colorado, 80523
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- tDCS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called The Travel Model v2.0 Advanced tDCS Kit, The Brian Simulator
Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: tDCS |
| 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 Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: At session 1 and minimum of 7 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thorsten Rudroff, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987621
- Sponsor's protocol ID
- 16-6856H
- Status last verified
- Jul 2020
- First submitted
- 5 Dec 2016
- Last updated
- 30 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
- ClinicalTrials.gov ID
- NCT02987621
- Acronym / sponsor ID
- 16-6856H
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham first, wash out 7 days, then tDCS | Experimental | Device: tDCSSeparated 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 |
| tDCS first, wash out 7 days, then Sham | Experimental | Device: tDCSSeparated 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: The Travel Model v2.0 Advanced tDCS Kit, The Brian SimulatorLess than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation. | Device | Sham first, wash out 7 days, then tDCS, tDCS first, wash out 7 days, then Sham |
Primary outcome
Leg Muscle Strength With and Without tDCS.
Time frame: At session 1 and minimum of 7 days later
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.
Time frame: At session 1 and minimum of 7 days later.
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
Time frame: At session 1 and minimum of 7 days later
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Multiple Sclerosis, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg Muscle Strength With and Without tDCS. (time frame: At session 1 and minimum of 7 days later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.