NCT05500963 · University of Colorado, Boulder
Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS
What this study is about
The objective of the randomly assigned, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boulder, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 9, 2024 · Source of record for eligibility and locations