Reducing fatigue in people with multiple sclerosis using TENS treatment
Reducing Fatigue in People With Multiple Sclerosis by Treatment With Transcutaneous Electrical Nerve Stimulation
This study is testing whether TENS treatment can help reduce fatigue in people with multiple sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Colorado, Boulder Academic / other |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT05500963 on ClinicalTrials.gov |
What this trial studies
This randomized, sham-controlled trial aims to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) in reducing fatigue levels in individuals with multiple sclerosis (MS). Participants aged 18-65 will be randomly assigned to receive either an effective dose of TENS or a sham treatment over 18 sessions across 6 weeks. The study will measure changes in self-reported fatigue and fatigability before, during, and after the intervention. The ultimate goal is to develop strategies to lessen the impact of fatigue on daily activities for those living with MS.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18-65 with a clinical diagnosis of relapsing-remitting MS who experience difficulty with walking.
Not a fit: Patients with significant sensory issues, recent surgeries, or other medical conditions that contraindicate exercise training may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with multiple sclerosis by reducing fatigue.
How similar studies have performed: While the approach of using TENS for fatigue in MS is relatively novel, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boulder, Colorado
- University of Colorado — Boulder, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Roger Enoka, PhD
- Email: enoka@colorado.edu
- Phone: 3034927232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.