Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS
NCT ID: NCT05500963
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-04-25
2028-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Colorado, Boulder
OTHER
Responsible Party
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Roger Enoka
Professor
Locations
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University of Colorado
Boulder, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Roger Enoka
Role: primary
References
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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.
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. 2018 Jan;32(1):84-93. doi: 10.1177/1545968317753681. Epub 2018 Jan 24.
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.2019.101508. Epub 2019 Nov 6.
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 Kinesiol. 2021 Dec;61:102607. doi: 10.1016/j.jelekin.2021.102607. Epub 2021 Oct 13.
Other Identifiers
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22-0394
Identifier Type: -
Identifier Source: org_study_id