Multiple Sclerosis Clinical Trial
Official title:
Reducing Fatigue in People With Multiple Sclerosis by Treatment With Transcutaneous Electrical Nerve Stimulation
NCT number | NCT05500963 |
Other study ID # | 22-0394 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 25, 2023 |
Est. completion date | March 2028 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Boulder |
United States,
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
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 |
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