RECRUITING

Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-05-25

Study Completion:2028-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05500963

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Roger Enoka, PhD

CONTACT

3034927232

enoka@colorado.edu

Study Locations (Sites)

University of Colorado

Boulder, Colorado, 80309

United States

Collaborators and Investigators

Sponsor: University of Colorado, Boulder

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-25

Study Completion Date2028-03

Study Record Updates

Study Start Date2023-05-25

Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

Multiple Sclerosis