New York University School of Medicine
New York, 10016, United States
NCT Number: NCT03658668
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
New York, 10016, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability.
Other names: Soterix 1x1 tDCS mini-CT
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
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
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
Time frame: End of Final Treatment Session (Up to Week 3)
Time frame: 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.
Time frame: 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.
NYU Langone Health
Other
Study of the Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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