Reducing Fatigue in People With Multiple Sclerosis by Treatment With Transcutaneous Electrical Nerve Stimulation

RecruitingNot a drug-phase studyRelapsing MSNCT05500963

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Transcutaneous electrical nerve stimulation

What it measured

Main measures

  • Fatigue

    Changes at Weeks 4, 7, and 11

    Fatigue
  • Walking limitations

    Changes at Weeks 4, 7, and 11

    Walking and mobility
  • Walking endurance

    Changes at Weeks 4, 7, and 11

    Walking and mobility
  • Mobility

    Changes at Weeks 4, 7, and 11

    Walking and mobility

Other measures (2)

  • Quality of life questionnaire

    Changes at Weeks 4, 7, and 11

    Quality of life (reported by participants)
  • Muscle strength

    Changes at Weeks 4, 7, and 11

    Physical function

Who could take part

Relapsing MS · 18 to 65

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Apr 2023

    2. Main results due

      May 2027

    3. Finished

      Nov 2028

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