Improving Mobility and Reducing Fatigue in People With Multiple Sclero
Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy
What it found
The trial ended early for another reason (see below).
Reason given: The project was not funded.
What was tested
Treatment tested
- Transcutaneous electrical nerve stimulation
What it measured
Main measures
Change in Gait Speed
Change from baseline at weeks 4, 8, and 12.
Walking and mobilityChange in Walking Endurance
Change from baseline at weeks 4, 8, and 12
Walking and mobilityChange in Dynamic Balance
Change from baseline at weeks 4, 8, and 12
Walking and mobilityChange in Patient Determined Disease Steps
Change from baseline at weeks 4, 8, and 12
Change in Modified Fatigue Impact Scale
Change from baseline at weeks 4, 8, and 12.
FatigueChange in MS Walking Scale-12
Change from baseline at weeks 4, 8, and 12.
Walking and mobility
Other measures (7)
Change in Romberg Quotient
Change from baseline at weeks 4, 8, and 12.
Change Conditioned H-reflex Amplitude
Change from baseline at weeks 4, 8, and 12.
Change in Proprioception Tract
Change from baseline at weeks 4, 8, and 12.
MRI lesionsChange in Muscle Synergy Number
Change from baseline at weeks 4, 8, and 12
Walking and mobilityChange in Force Steadiness
Change from baseline at weeks 4, 8, and 12.
Change in Muscle Synergy TIming
Change from baseline at weeks 4, 8, and 12.
Walking and mobilityChange in Discharge characteristics
Change from baseline at weeks 4, 8, and 12.
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
* Able to read, write, and speak English to ensure safe participation in the project * Clinical diagnosis of multiple sclerosis * Mild-to-moderate level of disability * On stable doses of symptom-treating medications * No MS exacerbations within the last 30 day * Healthy enough to complete the protocol as indicated by the absence of a medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in tests that involve electrical nerve stimulation (e.g., not implanted devices or internal metal) * Able to arrange own transportation to Boulder campus
Exclusion criteria
* Documented MS-related relapse within the last 30 days * Medical diagnosis or condition that is considered to be a contraindication to participating in the intervention, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than basal cell cancer), other neurological disorders, or pregnancy. * Vestibular disorder * Musculoskeletal disorder * History of seizure disorders * >2 alcoholic drinks/day,or present history (last 6 months) of drug abuse * Spasticity that requires the individual to change an activity more than once a week * Skin disease or sensation problems in the legs or hands that influence some activities more than once a week * Claustrophobia * Metallic implants * Inability to attend treatment sessions 3 days per week for 6 weeks
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. The hypothesis is that activation of sensory nerve fibers with augmented TENS promotes recovery of sensorimotor function and improves the disability status of individuals with MS. The rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with MS to manage walking limitations and fatigue.
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History
Started
Jul 2020
Main results due
Dec 2024
Finished
Jun 2025