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NCT Number: NCT05500963

Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Boulder, Colorado, 80309, United States

Location status: Recruiting

Location contact

Roger Enoka

CONTACT

[email protected]

303-492-7232

About this study

We will compare the changes in self-reported levels of fatigue (symptom intensity) and measures of fatigability (work capacity) from before to after a 6-week intervention. Participants (18-65 yrs) will be randomly assigned to one of two groups: one group will receive an effective dose of TENS and the other group (control) will be given a sham dose of TENS. The treatment will be applied during 18 sessions (3x/week for 6 weeks) and delivered through electrodes placed on the skin overlying the dorsiflexor (tibialis anterior) and hip flexor (rectus femoris) muscles of both legs. Participants will be evaluated before (Week 0), during (Week 4), and after (Weeks 7 and 11) the 6-week intervention.

Our long-term goal is to develop strategies that can reduce the impact of fatigue on the daily activities of persons with MS. The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with TENS at reducing the level of fatigue experienced by people with MS. Our central hypothesis is that treatment with TENS applied to selected leg muscles in people with MS will produce superior improvements in self-reported and measured levels of fatigue and fatigability compared with a sham dose of TENS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous electrical nerve stimulation

Device

Electrical stimulation applied over selected leg muscle will activate sensory receptors that will transmit signals back into the central nervous system.

Primary outcomes

  1. Fatigue

    Time frame: Changes at Weeks 4, 7, and 11

    Questionnaire scores - PROMIS Fatigue (MS) 8a

  2. Walking limitations

    Time frame: Changes at Weeks 4, 7, and 11

    Questionnaire scores - MS Walking Scale-12

  3. Walking endurance

    Time frame: Changes at Weeks 4, 7, and 11

    6-min walk test in meters

  4. Mobility

    Time frame: Changes at Weeks 4, 7, and 11

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

Secondary outcomes

  1. Quality of life questionnaire

    Time frame: Changes at Weeks 4, 7, and 11

    Questionnaire scores

  2. Muscle strength

    Time frame: Changes at Weeks 4, 7, and 11

    Maximal force in newtons applied by the dorsiflexors and hip flexors of each leg

Study contacts

Contact information is provided by the study sponsor or research team.

Roger Enoka, PhD

CONTACT

[email protected]

3034927232

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 15, 2022
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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