Trial Outcomes & Findings for Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis (NCT NCT03658668)
NCT ID: NCT03658668
Last Updated: 2023-08-16
Results Overview
Measured by a 10 meter walk test using wearable inertial sensors
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Results posted on
2023-08-16
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
9
|
|
Overall Study
COMPLETED
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Time Commitment
|
1
|
1
|
Baseline Characteristics
Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Active tDCS+PA
n=12 Participants
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
|
Sham tDCS+PA
n=8 Participants
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
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 12.3 • n=93 Participants
|
55 years
STANDARD_DEVIATION 7.55 • n=4 Participants
|
54.3 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
8 participants
n=4 Participants
|
20 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Sham tDCS+PA
n=6 Participants
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
|
Active tDCS+PA
n=9 Participants
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
|
|---|---|---|
|
Change in Gait Velocity
|
0.01 meters/second (m/s)
Standard Deviation 0.33
|
0.33 meters/second (m/s)
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Sham tDCS+PA
n=6 Participants
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
|
Active tDCS+PA
n=9 Participants
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
|
|---|---|---|
|
Change in Stride Length
|
-0.02 meters (m)
Standard Deviation 0.2
|
0.32 meters (m)
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: End of Final Treatment Session (Up to Week 3)Outcome measures
| Measure |
Sham tDCS+PA
n=6 Participants
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
|
Active tDCS+PA
n=9 Participants
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
|
|---|---|---|
|
Percent of tDCS Sessions Completed
|
100 Percentage
Standard Deviation 0
|
100 Percentage
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sham tDCS+PA
n=6 Participants
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
|
Active tDCS+PA
n=9 Participants
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
|
|---|---|---|
|
Change in 12-item Multiple Sclerosis Walking Scale Score
|
-2.5 score on a scale
Standard Deviation 2.9
|
-4.9 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sham tDCS+PA
n=6 Participants
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
|
Active tDCS+PA
n=9 Participants
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
|
|---|---|---|
|
Change 21-item Modified Fatigue Impact Scale Score
|
1.6 score on a scale
Standard Deviation 8.7
|
-12.4 score on a scale
Standard Deviation 10.4
|
Adverse Events
Active tDCS+PA
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Sham tDCS+PA
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS+PA
n=13 participants at risk
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
|
Sham tDCS+PA
n=9 participants at risk
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
|
|---|---|---|
|
General disorders
Tingling at the electrode site
|
76.9%
10/13 • 10 days
Standard questionnaire.
|
88.9%
8/9 • 10 days
Standard questionnaire.
|
|
General disorders
Itching at the electrode site
|
69.2%
9/13 • 10 days
Standard questionnaire.
|
66.7%
6/9 • 10 days
Standard questionnaire.
|
|
General disorders
Warmth Sensation at the electrode site
|
38.5%
5/13 • 10 days
Standard questionnaire.
|
44.4%
4/9 • 10 days
Standard questionnaire.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place