NCT05500963Recruiting
Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS
Reducing Fatigue in People With Multiple Sclerosis by Treatment With Transcutaneous Electrical Nerve Stimulation
Source: ClinicalTrials.gov · Last updated 9 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 8 Aug 2022
- Start date
- 25 Apr 2023
- Primary completion date
- 31 May 2027
- Lead sponsor
- University of Colorado, Boulder
- Diseases
- Multiple sclerosis
- NCT number
- NCT05500963
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 25 Apr 2023 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgery to the arms or legs that continues to bother the participant
- Metal implants
- Taking antidepressants, anticholinergics, stimulants, sedatives, cannabis, illicit drugs or medications to treat herpes or neurologic pain.
- ≥2 alcoholic drinks/day, or present history (last 6 months) of drug abuse
Other illness
- 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
- Diagnosis of diabetes mellitus
- Poorly controlled hypertension
- History of seizure disorders
- Skin diseases or sensation problems in the legs or hands that influences some activities more often than once a week
Other
- 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
- Spasticity that requires the individual to change intended activities more often than once a week
- Inability to attend exercise sessions 3 days per week for 6 weeks
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Boulder | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.