University of Colorado
Boulder, Colorado, 80309, United States
Location status: Recruiting
NCT Number: NCT05500963
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Boulder, Colorado, 80309, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electrical stimulation applied over selected leg muscle will activate sensory receptors that will transmit signals back into the central nervous system.
Time frame: Changes at Weeks 4, 7, and 11
Questionnaire scores - PROMIS Fatigue (MS) 8a
Time frame: Changes at Weeks 4, 7, and 11
Questionnaire scores - MS Walking Scale-12
Time frame: Changes at Weeks 4, 7, and 11
6-min walk test in meters
Time frame: Changes at Weeks 4, 7, and 11
Assessment of static and dynamic balance with Mobility Lab, APDM Inc
Time frame: Changes at Weeks 4, 7, and 11
Questionnaire scores
Time frame: Changes at Weeks 4, 7, and 11
Maximal force in newtons applied by the dorsiflexors and hip flexors of each leg
Contact information is provided by the study sponsor or research team.
University of Colorado, Boulder
Other
Reducing Fatigue in People With Multiple Sclerosis by Treatment With Transcutaneous Electrical Nerve Stimulation
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