Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

Part of paid clinical trials in Boulder, Colorado.

Sponsor
University of Colorado, Boulder
Study ID
NCT05500963
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 25, 2023
Status verified
Dec 2024
Primary completion
May 31, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Fatigue [ Time Frame: Changes at Weeks 4, 7, and 11 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoBoulderColorado80309
Roger Enoka
[email protected]
303-492-7232

Find similar trials in Boulder, CO

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
University of Colorado· Boulder, CO

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