Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500963
• Other study ID #: 22-0394
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: March 2028

Study information

• Verified date: May 2023
• Source: University of Colorado, Boulder
• Contact: Roger Enoka, PhD
• Phone: 3034927232
• Email: enoka[@]colorado.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2028
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alenazy M, Daneshgar Asl S, Petrigna L, Feka K, Alvarez E, Almuklass AM, Enoka RM. Treatment with electrical stimulation of sensory nerves improves motor function and disability status in persons with multiple sclerosis: A pilot study. J Electromyogr Kine — View Citation

Almuklass AM, Capobianco RA, Feeney DF, Alvarez E, Enoka RM. Sensory nerve stimulation causes an immediate improvement in motor function of persons with multiple sclerosis: A pilot study. Mult Scler Relat Disord. 2020 Feb;38:101508. doi: 10.1016/j.msard.2 — View Citation

Almuklass AM, Davis L, Hamilton LD, Hebert JR, Alvarez E, Enoka RM. Pulse Width Does Not Influence the Gains Achieved With Neuromuscular Electrical Stimulation in People With Multiple Sclerosis: Double-Blind, Randomized Trial. Neurorehabil Neural Repair. — View Citation

Enoka RM, Almuklass AM, Alenazy M, Alvarez E, Duchateau J. Distinguishing between Fatigue and Fatigability in Multiple Sclerosis. Neurorehabil Neural Repair. 2021 Nov;35(11):960-973. doi: 10.1177/15459683211046257. Epub 2021 Sep 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Questionnaire scores - PROMIS Fatigue (MS) 8a	Changes at Weeks 4, 7, and 11
Primary	Walking limitations	Questionnaire scores - MS Walking Scale-12	Changes at Weeks 4, 7, and 11
Primary	Walking endurance	6-min walk test in meters	Changes at Weeks 4, 7, and 11
Primary	Mobility	Assessment of static and dynamic balance with Mobility Lab, APDM Inc	Changes at Weeks 4, 7, and 11
Secondary	Quality of life questionnaire	Questionnaire scores	Changes at Weeks 4, 7, and 11
Secondary	Muscle strength	Maximal force in newtons applied by the dorsiflexors and hip flexors of each leg	Changes at Weeks 4, 7, and 11