Multiple SclerosisNCT03658668
Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
A study testing active tDCS and Physical Activity (PA) in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
Trial summary
This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- active tDCS and Physical Activity (PA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2018to 10 Jun 2021
- 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
- Stable and continuous access to internet service at home
- Adequate home facilities (enough space, access to quiet and distraction free area)
- Definite MS diagnosis, subtype relapsing-remitting (RR-MS)
- Disability Status Scale (EDSS) from 1 to 6.5 with clinically significant gait deviations
- Clinically stable and stable on treatment with disease modifying agents at least from 6 months
- Able to independently walk with or without an assisting device (i.e. cane, crutches or walking frames) for medium-long distance
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- Absence of other associated medical conditions that would prevent participants from performing physical activity, such as cardiorespiratory and severe osteoarticular disorders
- Able to use study equipment
- Able to commit 10 consecutive daily sessions of tDCS while performing physical program with baseline and follow-up visits
- Able to understand the informed consent process and provide consent to participate in the study
Who cannot join
- Visual, auditory and motor deficits that would prevent full ability to understand study, as judged by treating neurologist or study staff
- Primary psychiatric disorder that would influence ability to participate
- Receiving current treatment for epilepsy
- Uncontrolled headaches and migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded
- History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
- Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
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- Treatment for a communicable skin disorder currently or over the past 12 months
- History of uncontrolled or labile hypertension
- Other serious uncontrolled medical condition (e.g. cancer or acute myocardial infarction)
- Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score < 85
- History of clinically significant abnormalities on electrocardiogram (EKG)
- Presence of chronic medical illness and/or severe ataxia
- Botulinum toxin injection within the past 4 months or functional surgery in the past 6 months
- Alcohol or other substance use disorder
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Study of the Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.
The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA).
Portions of this study may be completed remotely.
- Conditions
- Multiple Sclerosis
- Being tested
- active tDCS, sham tDCS, Physical Activity (PA)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSDevice
Also called Soterix 1x1 tDCS mini-CT
tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability.
sham tDCSDevice
During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Physical Activity (PA)Other
20 minutes of cycling on an ergonomic cross-trainer
| Study group | Role | What they receive |
|---|---|---|
| active tDCS+PA | Experimental | Not described Receives: Device: active tDCS; Other: Physical Activity (PA) |
| sham tDCS+PA | Sham comparator | Not described Receives: Device: sham tDCS; Other: Physical Activity (PA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Velocity
Measured by a 10 meter walk test using wearable inertial sensors
Measured: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Change in Stride Length
Measured by a 10 meter walk test using wearable inertial sensors
Measured: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Secondary outcomes (3)
Percent of tDCS Sessions Completed
Measured: End of Final Treatment Session (Up to Week 3)
Change in 12-item Multiple Sclerosis Walking Scale Score
12-item questionnaire assessing how multiple sclerosis (MS) affects walking abilities. Items are ranked on a scale from 1 (not at all) to 5 (extremely). The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater impact of MS on walking abilities.
Measured: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Change 21-item Modified Fatigue Impact Scale Score
21-item questionnaire assessing how fatigue may affect a person. Items are ranked on a scale from 0 (never) to 4 (almost always). The total score is the sum of responses and ranges from 0 to 84; scores indicate greater impact of fatigue.
Measured: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start3 Oct 2018
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
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 Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658668
- Sponsor's protocol ID
- 18-00534
- Status last verified
- Jul 2023
- First submitted
- 14 Aug 2018
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Pilloni G, Choi C, Coghe G, Cocco E, Krupp LB, Pau M, Charvet LE. Gait and Functional Mobility in Multiple Sclerosis: Immediate Effects of Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise. Front Neurol. 2020 May 5;11:310. doi: 10.3389/fneur.2020.00310. eCollection 2020.
PubMed 32431658
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03658668
- Acronym / sponsor ID
- 18-00534
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.
The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA).
Portions of this study may be completed remotely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS+PA | Experimental | Device: active tDCS, Other: Physical Activity (PA) |
| sham tDCS+PA | Sham comparator | Device: sham tDCS, Other: Physical Activity (PA) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Stable and continuous access to internet service at home
- Adequate home facilities (enough space, access to quiet and distraction free area)
- Definite MS diagnosis, subtype relapsing-remitting (RR-MS)
- Disability Status Scale (EDSS) from 1 to 6.5 with clinically significant gait deviations
- Clinically stable and stable on treatment with disease modifying agents at least from 6 months
Key exclusion criteria (15 listed)
- Visual, auditory and motor deficits that would prevent full ability to understand study, as judged by treating neurologist or study staff
- Primary psychiatric disorder that would influence ability to participate
- Receiving current treatment for epilepsy
- Uncontrolled headaches and migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded
- History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
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 |
|---|---|---|
| active tDCSAlso: Soterix 1x1 tDCS mini-CTtDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability. | Device | active tDCS+PA |
| sham tDCSDuring a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. | Device | sham tDCS+PA |
| Physical Activity (PA)20 minutes of cycling on an ergonomic cross-trainer | Other | active tDCS+PA, sham tDCS+PA |
Primary outcome
Change in Gait Velocity
Time frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Measured by a 10 meter walk test using wearable inertial sensors
Change in Stride Length
Time frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Measured by a 10 meter walk test using wearable inertial sensors
3 secondary outcomes
Percent of tDCS Sessions Completed
Time frame: End of Final Treatment Session (Up to Week 3)
Change in 12-item Multiple Sclerosis Walking Scale Score
Time frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Change 21-item Modified Fatigue Impact Scale Score
Time frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32431658Pilloni G, Choi C, Coghe G, Cocco E, Krupp LB, Pau M, Charvet LE. Gait and Functional Mobility in Multiple Sclerosis: Immediate Effects of Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise. Front Neurol. 2020 May 5;11:310. doi: 10.3389/fneur.2020.00310. eCollection 2020.
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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.
Leigh Charvet, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS and Physical Activity (PA) in people with Multiple Sclerosis, run by NYU Langone Health 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 10 inclusion and 15 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 16 Aug 2023. 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. Some participants in this study may receive a placebo. 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 16 Aug 2023). 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?
Change in Gait Velocity (time frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)). 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 NCT03658668, 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 16 Aug 2023.