Multiple Sclerosis
Conditions
Brief 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). 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.
Interventions
DEVICEactive tDCS
tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\<4 mA) to induce changes in cortical excitability.
DEVICEsham tDCS
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.
20 minutes of cycling on an ergonomic cross-trainer
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Velocity | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of tDCS Sessions Completed | End of Final Treatment Session (Up to Week 3) | — |
| Change in 12-item Multiple Sclerosis Walking Scale Score | Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks) | 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. |
| Change 21-item Modified Fatigue Impact Scale Score | Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS+PA active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\<4 mA) to induce changes in cortical excitability.
Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer | 12 |
| Sham tDCS+PA sham tDCS: 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): 20 minutes of cycling on an ergonomic cross-trainer | 8 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Time Commitment | 1 | 1 |
Baseline characteristics
| Characteristic | Active tDCS+PA | Total | Sham tDCS+PA |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 12.3 | 54.3 years STANDARD_DEVIATION 10.3 | 55 years STANDARD_DEVIATION 7.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 11 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 8 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 14 Participants | 6 Participants |
| Region of Enrollment United States | 12 participants | 20 participants | 8 participants |
| Sex: Female, Male Female | 8 Participants | 14 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 9 |
| other Total, other adverse events | 12 / 13 | 9 / 9 |
| serious Total, serious adverse events | 0 / 13 | 0 / 9 |
Outcome results
Primary
Change in Gait Velocity
Measured by a 10 meter walk test using wearable inertial sensors
Time frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS+PA | Change in Gait Velocity | 0.33 meters/second (m/s) | Standard Deviation 0.32 |
| Sham tDCS+PA | Change in Gait Velocity | 0.01 meters/second (m/s) | Standard Deviation 0.33 |
Primary
Change in Stride Length
Measured by a 10 meter walk test using wearable inertial sensors
Time frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS+PA | Change in Stride Length | 0.32 meters (m) | Standard Deviation 0.17 |
| Sham tDCS+PA | Change in Stride Length | -0.02 meters (m) | Standard Deviation 0.2 |
Secondary
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.
Time frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS+PA | Change 21-item Modified Fatigue Impact Scale Score | -12.4 score on a scale | Standard Deviation 10.4 |
| Sham tDCS+PA | Change 21-item Modified Fatigue Impact Scale Score | 1.6 score on a scale | Standard Deviation 8.7 |
Secondary
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.
Time frame: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS+PA | Change in 12-item Multiple Sclerosis Walking Scale Score | -4.9 score on a scale | Standard Deviation 3.2 |
| Sham tDCS+PA | Change in 12-item Multiple Sclerosis Walking Scale Score | -2.5 score on a scale | Standard Deviation 2.9 |
Secondary
Percent of tDCS Sessions Completed
Time frame: End of Final Treatment Session (Up to Week 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS+PA | Percent of tDCS Sessions Completed | 100 Percentage | Standard Deviation 0 |
| Sham tDCS+PA | Percent of tDCS Sessions Completed | 100 Percentage | Standard Deviation 0 |