NCT05500963

Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Colorado, Boulder · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Transcutaneous electrical nerve stimulation	Electrical stimulation applied over selected leg muscle will activate sensory receptors that will transmit signals back into the central nervous system.

Timeline

• Start date: 2023-04-25
• Primary completion: 2027-05-31
• Completion: 2028-11-30
• First posted: 2022-08-15
• Last updated: 2024-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study