Transcranial Direct Current StimulationNCT03757819
Transcranial Direct Current Stimulation and Walking in Multiple Sclerosis
A study testing tDCS in people with Transcranial Direct Current Stimulation, run by Thorsten Rudroff at 1 site in United States.
Trial summary
Weakness on one side of the body is a hallmark of Multiple Sclerosis (MS), which has been determined to be a significant cause of progressive worsening of walking abilities. Currently, there are no efficient rehabilitation strategies available to target strength asymmetries and walking impairments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transcranial Direct Current Stimulation
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 7 Jul 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medically diagnosed with Multiple Sclerosis,
- moderate disability (Patient Determined Disease Steps (PDDS) core 2-6), -self-- reported differences in function between legs, able to walk for 6min. -
Who cannot join
- relapse within last 60 days,
- high risk for cardiovascular disease (ACSM risk classification),
- changes in disease modifying medications within last 45 days,
- concurrent neurological/neuromuscular disease,
- hospitalization within last 90 days,
- diagnosed depression, inability to understand/sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Transcranial Direct Stimulation Improve Walking in Multiple Sclerosis?
Weakness on one side of the body is a hallmark of Multiple Sclerosis (MS), which has been determined to be a significant cause of progressive worsening of walking abilities. Currently, there are no efficient rehabilitation strategies available to target strength asymmetries and walking impairments. Many of the current treatments, including pharmaceuticals, are only mildly effective and are often very expensive. Thus, the development of practical, inexpensive, and effective adjunct treatments is needed.
The study is to examine the efficacy of different tDCS protocols at improving walking in PwMS. Although the details of the studies slightly vary, the global aspects of the experimental procedures are identical with the exception that the tDCS stimulation parameter timing differs between the groups. The study will be double-blind, sham-controlled, randomized cross-over design.
Read more
Maximal voluntary contractions (MVCs) of the right and left knee extensors, knee flexors, hip flexors, and dorsiflexors will be performed to determine the more-affected leg.
The study compromises 2 groups of subjects which will attend the lab for three sessions. In the first session subjects will be consented, complete the PDDS, the Fatigue Severity Scale (FSS), and a 6 minute walk test (6-MWT) for baseline performance. The second session will involve a 6 MWT performed in association with 2 conditions. Group 1: DURINGtDCS, DURINGSHAM. Group 2: BEFOREtDCS, BEFORESHAM. The conditions in each group will be in a randomized order. Intensity of tDCS will be 2mA for both groups. Group 1 will receive the conditions during the 6 MWT. tDCS for 6 min has been shown to be sufficient to induce cortical excitability. Group 2 will receive 13 min of tDCS or sham, which results in after effects lasting through the completion of the 6 MWT. tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg either before or during the 6 min walk test
Read the detailed description
Prospective participants, men and women with MS, will be recruited. To accomplish this study, each of the two groups of participants will need to complete 3 sessions at the INPL, each separated by 5-8 days. The duration of each session will be approximately one hour. The investigators expect data collection to last 6 months.
The study compromises 2 groups of subjects which will attend the lab for three sessions. In the first session subjects will be consented, complete the Patient Determined Disease Steps (PDDS) questionnaire, the Fatigue Severity Scale (FSS), and a 6MWT for baseline performance. The second session will involve a 6 MWT performed in association with 2 conditions. Group 1: DURING_tDCS, DURING_SHAM. Group 2: BEFORE_tDCS, BEFORE_SHAM. tDCS will be applied first follwed by SHAM in each group. Intensity of tDCS will be 2mA for both groups. Group 1 will receive the conditions during the 6 MWT. tDCS for 6 min has been shown to be sufficient to induce cortical excitability. Group 2 will receive 13 min of tDCS or sham which results in after effects lasting through the completion of the 6MWT. tDCS will be applied to the motor cortex (M1)corresponding to the more-affected leg either before or during the 6 min walk test. Leg strength, 6 MWT, and tDCS: Maximal voluntary contractions (MVCs) of the right and left knee extensors, knee flexors, hip flexors, and dorsiflexors will be performed to determine the more-affected leg. When leg strength difference is less than 10%, the more affected side will be based on self-report. For the 6 MWT, participants will be asked to walk as far as they can in 6 minutes. The 6 MWT is well established in MS research and, in order to measure fatigability as a secondary outcome, the literature suggest using a 6MWT rather than a 2MWT.Participants will walk in a cordoned off hallway between two cones placed approximately 30 meters apart. The primary outcome measure will be the distance covered in the 6 MWT. Since the investigators hypothesize that tDCS will alter the utilization of their more-affected leg, standard gait metrics during the 6MWT including gait speed, cadence, stride length and time, step length and time will be assessed with inertial sensors (OPAL system) for tDCS and SHAM (secondary outcomes). Furthermore, the investigators will calculate the distance walked index (DWI, distance Min 1 - distance Min 6), which is an objective measure of fatigability. A tDCS device (ActivaDose II) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm,soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit. The following sessions will be performed in randomized order. Group 1 (During) - (A) The participant will receive tDCS or SHAM throughout the walking. In the tDCS trial the intensity will start at 0 mA and will be increased to 2mA over a 30 second period of time. At the 6:30 minute time point (immediately after walking) the current will gradually be reduced from 2 mA to 0 mA. (B) In the sham condition the participants will only receive the initial 30 seconds of stimulation, after which the current will be set to 0. Group 2 (Before) - (C) After a 30s ramp-up, tDCS will be delivered for 13 minutes at an intensity of 2 mA before the 6 min walk test. At the 13:00 minute time point the current will gradually be reduced from 2 mA to 0 mA. (D) Participants who undergo a sham condition will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 (D). In session 3, the condition not performed during session 2 will be performed. E.g., if a patient in Group 1 was randomly assigned DURING_SHAM for session 2, the patient will perform DURING_tDCS in session 3. All other testing conditions will be the same as session 2.
There will be no long-term follow up.
- Conditions
- Transcranial Direct Current Stimulation
- Being tested
- tDCS, SHAM
- Keywords
- Multiple Scerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Brain Stimulation
SHAMDevice
Placebo device
| Study group | Role | What they receive |
|---|---|---|
| Before Walking tDCS first then SHAM | Experimental | To investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention. Receives: Device: tDCS; Device: SHAM |
| During Walking tDCS first then SHAM | Experimental | To investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention. Receives: Device: tDCS; Device: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Walked on a Treadmill With tDCS
6 min walk test
Measured: one week
Distance Walked on a Treadmill With SHAM
6 min walk test
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start25 Feb 2019
- Primary completion7 Jul 2019
- Study completion7 Jul 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Direct Current StimulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study employed a double-blind, sham-controlled, parallel-randomized crossover design. Each participant attended three sessions. In the first session, participants were consented and completed the Patient-Determined Disease State and Fatigue Severity Scale questionnaires. Then, after a counter-balanced randomization into BEFORE or DURING groups, the participants completed a 6-Minute Walk Test for baseline/familiarization purposes. The second and third sessions involved brain stimulation or sham stimulation either before or during a 6-Minute Walk Test, depending on group assignment. The brain stimulation was randomly assigned to either session two or three, and sham stimulation was performed in the other session.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thorsten Rudroff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thorsten Rudroff, University of Iowa
- Investigators
- Thorsten Rudroff, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757819
- Sponsor's protocol ID
- 201810705
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2018
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Workman CD, Kamholz J, Rudroff T. Transcranial Direct Current Stimulation (tDCS) to Improve Gait in Multiple Sclerosis: A Timing Window Comparison. Front Hum Neurosci. 2019 Nov 28;13:420. doi: 10.3389/fnhum.2019.00420. eCollection 2019.
PubMed 31849628
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Transcranial Direct Stimulation Improve Walking in Multiple Sclerosis?
- ClinicalTrials.gov ID
- NCT03757819
- Acronym / sponsor ID
- 201810705
- Conditions
- Transcranial Direct Current Stimulation
- Keywords
- Multiple Scerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Thorsten RudroffUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 7 Jul 2019 (actual)
- Study completion
- 7 Jul 2019 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Posted 21 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Weakness on one side of the body is a hallmark of Multiple Sclerosis (MS), which has been determined to be a significant cause of progressive worsening of walking abilities. Currently, there are no efficient rehabilitation strategies available to target strength asymmetries and walking impairments. Many of the current treatments, including pharmaceuticals, are only mildly effective and are often very expensive. Thus, the development of practical, inexpensive, and effective adjunct treatments is needed.
The study is to examine the efficacy of different tDCS protocols at improving walking in PwMS. Although the details of the studies slightly vary, the global aspects of the experimental procedures are identical with the exception that the tDCS stimulation parameter timing differs between the groups. The study will be double-blind, sham-controlled, randomized cross-over design.
Maximal voluntary contractions (MVCs) of the right and left knee extensors, knee flexors, hip flexors, and dorsiflexors will be performed to determine the more-affected leg.
The study compromises 2 groups of subjects which will attend the lab for three sessions. In the first session subjects will be consented, complete the PDDS, the Fatigue Severity Scale (FSS), and a 6 minute walk test (6-MWT) for baseline performance. The second session will involve a 6 MWT performed in association with 2 conditions. Group 1: DURINGtDCS, DURINGSHAM. Group 2: BEFOREtDCS, BEFORESHAM. The conditions in each group will be in a randomized order. Intensity of tDCS will be 2mA for both groups. Group 1 will receive the conditions during the 6 MWT. tDCS for 6 min has been shown to be sufficient to induce cortical excitability. Group 2 will receive 13 min of tDCS or sham, which results in after effects lasting through the completion of the 6 MWT. tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg either before or during the 6 min walk test
Detailed description
Prospective participants, men and women with MS, will be recruited. To accomplish this study, each of the two groups of participants will need to complete 3 sessions at the INPL, each separated by 5-8 days. The duration of each session will be approximately one hour. The investigators expect data collection to last 6 months.
The study compromises 2 groups of subjects which will attend the lab for three sessions. In the first session subjects will be consented, complete the Patient Determined Disease Steps (PDDS) questionnaire, the Fatigue Severity Scale (FSS), and a 6MWT for baseline performance. The second session will involve a 6 MWT performed in association with 2 conditions. Group 1: DURING_tDCS, DURING_SHAM. Group 2: BEFORE_tDCS, BEFORE_SHAM. tDCS will be applied first follwed by SHAM in each group. Intensity of tDCS will be 2mA for both groups. Group 1 will receive the conditions during the 6 MWT. tDCS for 6 min has been shown to be sufficient to induce cortical excitability. Group 2 will receive 13 min of tDCS or sham which results in after effects lasting through the completion of the 6MWT. tDCS will be applied to the motor cortex (M1)corresponding to the more-affected leg either before or during the 6 min walk test. Leg strength, 6 MWT, and tDCS: Maximal voluntary contractions (MVCs) of the right and left knee extensors, knee flexors, hip flexors, and dorsiflexors will be performed to determine the more-affected leg. When leg strength difference is less than 10%, the more affected side will be based on self-report. For the 6 MWT, participants will be asked to walk as far as they can in 6 minutes. The 6 MWT is well established in MS research and, in order to measure fatigability as a secondary outcome, the literature suggest using a 6MWT rather than a 2MWT.Participants will walk in a cordoned off hallway between two cones placed approximately 30 meters apart. The primary outcome measure will be the distance covered in the 6 MWT. Since the investigators hypothesize that tDCS will alter the utilization of their more-affected leg, standard gait metrics during the 6MWT including gait speed, cadence, stride length and time, step length and time will be assessed with inertial sensors (OPAL system) for tDCS and SHAM (secondary outcomes). Furthermore, the investigators will calculate the distance walked index (DWI, distance Min 1 - distance Min 6), which is an objective measure of fatigability. A tDCS device (ActivaDose II) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm,soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit. The following sessions will be performed in randomized order. Group 1 (During) - (A) The participant will receive tDCS or SHAM throughout the walking. In the tDCS trial the intensity will start at 0 mA and will be increased to 2mA over a 30 second period of time. At the 6:30 minute time point (immediately after walking) the current will gradually be reduced from 2 mA to 0 mA. (B) In the sham condition the participants will only receive the initial 30 seconds of stimulation, after which the current will be set to 0. Group 2 (Before) - (C) After a 30s ramp-up, tDCS will be delivered for 13 minutes at an intensity of 2 mA before the 6 min walk test. At the 13:00 minute time point the current will gradually be reduced from 2 mA to 0 mA. (D) Participants who undergo a sham condition will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 (D). In session 3, the condition not performed during session 2 will be performed. E.g., if a patient in Group 1 was randomly assigned DURING_SHAM for session 2, the patient will perform DURING_tDCS in session 3. All other testing conditions will be the same as session 2.
There will be no long-term follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study employed a double-blind, sham-controlled, parallel-randomized crossover design. Each participant attended three sessions. In the first session, participants were consented and completed the Patient-Determined Disease State and Fatigue Severity Scale questionnaires. Then, after a counter-balanced randomization into BEFORE or DURING groups, the participants completed a 6-Minute Walk Test for baseline/familiarization purposes. The second and third sessions involved brain stimulation or sham stimulation either before or during a 6-Minute Walk Test, depending on group assignment. The brain stimulation was randomly assigned to either session two or three, and sham stimulation was performed in the other session.
| Arm | Type | Receives |
|---|---|---|
| Before Walking tDCS first then SHAM | Experimental | Device: tDCS, Device: SHAMTo investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention. |
| During Walking tDCS first then SHAM | Experimental | Device: tDCS, Device: SHAMTo investigate the effects of tDCS applied before walking versus during to evaluate effectiveness of the intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- medically diagnosed with Multiple Sclerosis,
- moderate disability (Patient Determined Disease Steps (PDDS) core 2-6), -self-- reported differences in function between legs, able to walk for 6min. -
Key exclusion criteria (6 listed)
- relapse within last 60 days,
- high risk for cardiovascular disease (ACSM risk classification),
- changes in disease modifying medications within last 45 days,
- concurrent neurological/neuromuscular disease,
- hospitalization within last 90 days,
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 |
|---|---|---|
| tDCSBrain Stimulation | Device | Before Walking tDCS first then SHAM, During Walking tDCS first then SHAM |
| SHAMPlacebo device | Device | Before Walking tDCS first then SHAM, During Walking tDCS first then SHAM |
Primary outcome
Distance Walked on a Treadmill With tDCS
Time frame: one week
6 min walk test
Distance Walked on a Treadmill With SHAM
Time frame: one week
6 min walk test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31849628Workman CD, Kamholz J, Rudroff T. Transcranial Direct Current Stimulation (tDCS) to Improve Gait in Multiple Sclerosis: A Timing Window Comparison. Front Hum Neurosci. 2019 Nov 28;13:420. doi: 10.3389/fnhum.2019.00420. eCollection 2019.
- 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.
Thorsten Rudroff principal investigator
University of Iowa
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 Transcranial Direct Current Stimulation, run by Thorsten Rudroff 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 2 inclusion and 6 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 21 Dec 2022. 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 21 Dec 2022). 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?
Distance Walked on a Treadmill With tDCS (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03757819, which also lists 1 linked publication.
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 21 Dec 2022.