TENS Treatment for Fatigue in Multiple Sclerosis

This study is looking at whether Transcutaneous Electrical Nerve Stimulation (TENS) can help reduce fatigue in people with Multiple Sclerosis (MS). TENS uses electrical stimulation applied to leg muscles. Researchers will compare changes in fatigue, walking ability, and walking endurance in people receiving TENS versus a sham (inactive) treatment. You might be able to join if you are 18-65 years old, have relapsing-remitting MS, have difficulty walking, and are on stable doses of certain MS medications. The study aims to enroll 60 participants. The current recruitment status is unclear.

Study design
This is a randomized, sham-controlled study involving 60 participants. You would be randomly assigned to either receive TENS or a sham TENS treatment.
What's involved
You would receive 18 treatment sessions over 6 weeks (3 times a week). You would also have evaluations before, during (Week 4), and after (Weeks 7 and 11) the 6-week treatment period.
Compensation
Not stated in the trial record.
Follow-up
You will be evaluated at Week 7 and Week 11, which is after the 6-week intervention period.

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NCT05500963

Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

Recruiting
NAAges 18–65InterventionalTreatment
University of Colorado, Boulder
~60 participants
Updated 2024-12-09 on ClinicalTrials.gov
What's tested:Transcutaneous electrical nerve stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fatigue
Measured over Changes at Weeks 4, 7, and 11
+3 more outcomes measured
Multiple Sclerosis
1 sites across 1 states
Colorado1

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Eligibility criteria

Inclusion

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

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
  • FatigueChanges at Weeks 4, 7, and 11

    Questionnaire scores - PROMIS Fatigue (MS) 8a

  • Walking limitationsChanges at Weeks 4, 7, and 11

    Questionnaire scores - MS Walking Scale-12

  • Walking enduranceChanges at Weeks 4, 7, and 11

    6-min walk test in meters

  • MobilityChanges at Weeks 4, 7, and 11

    Assessment of static and dynamic balance with Mobility Lab, APDM Inc