Multiple Sclerosis
Conditions
Brief summary
The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with transcutaneous electrical nerve stimulation (TENS) at reducing the level of fatigue experienced by people with MS.
Detailed description
We will compare the changes in self-reported levels of fatigue (symptom intensity) and measures of fatigability (work capacity) from before to after a 6-week intervention. Participants (18-65 yrs) will be randomly assigned to one of two groups: one group will receive an effective dose of TENS and the other group (control) will be given a sham dose of TENS. The treatment will be applied during 18 sessions (3x/week for 6 weeks) and delivered through electrodes placed on the skin overlying the dorsiflexor (tibialis anterior) and hip flexor (rectus femoris) muscles of both legs. Participants will be evaluated before (Week 0), during (Week 4), and after (Weeks 7 and 11) the 6-week intervention. Our long-term goal is to develop strategies that can reduce the impact of fatigue on the daily activities of persons with MS. The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with TENS at reducing the level of fatigue experienced by people with MS. Our central hypothesis is that treatment with TENS applied to selected leg muscles in people with MS will produce superior improvements in self-reported and measured levels of fatigue and fatigability compared with a sham dose of TENS.
Interventions
DEVICETranscutaneous electrical nerve stimulation
Electrical stimulation applied over selected leg muscle will activate sensory receptors that will transmit signals back into the central nervous system.
Sponsors
University of Colorado, Boulder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women18-65 yrs * Able to read, understand, and speak English to ensure safe participation in the project * Clinical diagnosis of relapsing-remitting MS * Self-reported difficulty with walking * On stable doses of Ampyra, provigil, or other symptomatic-treating medications * No relapse or systemic steroids within the last 30 days * Able to arrange transportation to the Boulder campus
Exclusion criteria
* Vision or hearing problems that have not been corrected * Problems with sensations to temperature, pressure, or pain * Any arm or leg problems that would influence the ability to hold a weight * Surgery to the arms or legs that continues to bother the participant * Metal implants * 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 * History of head injury or stroke * Taking antidepressants, anticholinergics, stimulants, sedatives, cannabis, illicit drugs or medications to treat herpes or neurologic pain. * Diagnosis of diabetes mellitus * Poorly controlled hypertension * History of seizure disorders * ≥2 alcoholic drinks/day, or present history (last 6 months) of drug abuse * Spasticity that requires the individual to change intended activities more often than once a week * Skin diseases or sensation problems in the legs or hands that influences some activities more often than once a week * Inability to attend exercise sessions 3 days per week for 6 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Changes at Weeks 4, 7, and 11 | Questionnaire scores - PROMIS Fatigue (MS) 8a |
| Walking limitations | Changes at Weeks 4, 7, and 11 | Questionnaire scores - MS Walking Scale-12 |
| Walking endurance | Changes at Weeks 4, 7, and 11 | 6-min walk test in meters |
| Mobility | Changes at Weeks 4, 7, and 11 | Assessment of static and dynamic balance with Mobility Lab, APDM Inc |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life questionnaire | Changes at Weeks 4, 7, and 11 | Questionnaire scores |
| Muscle strength | Changes at Weeks 4, 7, and 11 | Maximal force in newtons applied by the dorsiflexors and hip flexors of each leg |
Countries
United States
Contacts
Primary ContactRoger Enoka, PhD
Outcome results
None listed