Trial Outcomes & Findings for Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis (NCT NCT02152085)
NCT ID: NCT02152085
Last Updated: 2021-05-07
Results Overview
Distance walked in 6 min
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Results posted on
2021-05-07
Participant Flow
Three potential participants did not meet eligibility requirements.
Participant milestones
| Measure |
Narrow Pulse
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.
Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.
|
Wide Pulse
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.
Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Narrow Pulse
n=14 Participants
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.
Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.
|
Wide Pulse
n=15 Participants
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.
Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 9 • n=93 Participants
|
55 years
STANDARD_DEVIATION 5 • n=4 Participants
|
55 years
STANDARD_DEVIATION 7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 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
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 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
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
15 participants
n=4 Participants
|
29 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).Distance walked in 6 min
Outcome measures
| Measure |
Narrow Pulse
n=14 Participants
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.
Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.
|
Wide Pulse
n=13 Participants
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.
Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.
|
|---|---|---|
|
Walking Endurance
|
42 meters
Standard Deviation 60
|
25 meters
Standard Deviation 35
|
PRIMARY outcome
Timeframe: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue.
Outcome measures
| Measure |
Narrow Pulse
n=14 Participants
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.
Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.
|
Wide Pulse
n=13 Participants
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.
Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.
|
|---|---|---|
|
Modified Fatigue Impact Scale
|
34 score on a scale
Standard Deviation 17
|
23 score on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).The time it takes to walk 25 ft
Outcome measures
| Measure |
Narrow Pulse
n=14 Participants
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms.
Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.
|
Wide Pulse
n=13 Participants
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms.
Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.
|
|---|---|---|
|
Maximal Walking Speed
|
-1.92 seconds
Standard Deviation 4.21
|
0.12 seconds
Standard Deviation 1.15
|
Adverse Events
Narrow Pulse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wide Pulse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place