Reducing Fatigue in People With Multiple Sclerosis by Treatment With Transcutaneous Electrical Nerve Stimulation
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
Colorado
University of Colorado
RECRUITING
Boulder
Contact Information
Primary
Roger Enoka, PhD
enoka@colorado.edu
3034927232
Time Frame
Start Date: 2023-04-25
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Effective dose
• The effective dose of TENS will be set at an intensity to elicit slight contractions in each target muscle, as we have done previously. It will be delivered as 5-Hz bursts (7 pulses at 100 Hz/burst) and applied during the light exercises. The applied current (\<20 mA) will differ slightly for each of the four muscle groups and will be determined while the person is standing. The current will be set at the beginning of every treatment session for both groups of participants.
Sham_comparator: Sham dose
• The current intensity for the sham dose will be set at sensory threshold, which will be less than that used for the effective dose. After beginning each exercise set, the current for the sham dose will decay to 0 mA within 30 s. In a preliminary study that included a sham dose of TENS, we found that only two of the experienced dancers in the sham group detected the gradual decline in TENS current from its initial value slightly above motor threshold when performing prescribed exercises.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Boulder