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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\<4 mA) to induce changes in cortical excitability.
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
New York University School of Medicine
New York, New York, United States
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)
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)
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
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)
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)
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