Multiple Sclerosis
Conditions
Keywords
Walking, Mobility, Neuromuscular electrical stimulation, Multiple sclerosis
Brief summary
The purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis.
Detailed description
Participants will be randomly assigned to one of two study arms. Those in one arm will receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will receive wide stimulus pulses (1 ms). The electrical stimulation will be delivered with a Vectra Genisys System.
Interventions
DEVICENarrow 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.
DEVICEWide 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Colorado, Boulder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Able to read, understand, and speak English to ensure safe participation in the project * Difficulties with walking * On stable doses of Ampyra, provigil, or other symptomatic-treating medications * No systemic steroids within the last 30 days * Not currently exercising more than 2x/wk * Able to arrange own transportation to and from the laboratories * Provide informed consent, including willingness to be randomly assigned to one of the two groups
Exclusion criteria
* Documented MS-related relapse in the last 3 months * Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy * Poorly controlled diabetes mellitus or hypertension * History of seizure disorders * Alcohol dependence or abuse (≥2 drinks/day), or present history (last 6 months) of drug abuse * Inability to attend exercise sessions 3 days per week for 6 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Endurance | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). | Distance walked in 6 min |
| Modified Fatigue Impact Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Walking Speed | 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 |
Countries
United States
Participant flow
Pre-assignment details
Three potential participants did not meet eligibility requirements.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 15 |
| Total | 29 |
Baseline characteristics
| Characteristic | Narrow Pulse | Total | Wide Pulse |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 9 | 55 years STANDARD_DEVIATION 7 | 55 years STANDARD_DEVIATION 5 |
| 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 | 1 Participants | 2 Participants | 1 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 | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 24 Participants | 12 Participants |
| Region of Enrollment United States | 14 participants | 29 participants | 15 participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Modified Fatigue Impact Scale
MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue.
Time frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrow Pulse | Modified Fatigue Impact Scale | 34 score on a scale | Standard Deviation 17 |
| Wide Pulse | Modified Fatigue Impact Scale | 23 score on a scale | Standard Deviation 14 |
Primary
Walking Endurance
Distance walked in 6 min
Time frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrow Pulse | Walking Endurance | 42 meters | Standard Deviation 60 |
| Wide Pulse | Walking Endurance | 25 meters | Standard Deviation 35 |
Secondary
Maximal Walking Speed
The time it takes to walk 25 ft
Time frame: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrow Pulse | Maximal Walking Speed | -1.92 seconds | Standard Deviation 4.21 |
| Wide Pulse | Maximal Walking Speed | 0.12 seconds | Standard Deviation 1.15 |