Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy

University of Colorado Boulder (CU)

Status: Withdrawn

Conditions: Multiple Sclerosis

Treatments: Device: Transcutaneous electrical nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03684369

UColoradoBoulder2

Details and patient eligibility

About

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.

Full description

The study will involve a randomized, double-blind, controlled trial. Randomization will be accomplished by recruiting two individuals with a similar level of disability at a time and flipping a coin (two persons present) to determine the group assignment (A or B) of the person who contacted the investigators first. The participants and outcome assessors will be blinded to group assignment. Both groups will receive the treatment (real or sham) during the first 4 weeks (3 sessions/week)and then there will be an 8-week follow-up period. Participants will be evaluated at weeks 0, 4, 8, and 12.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Augmented TENS

Experimental group

Description:

Transcutaneous electrical nerve stimulation applied to each leg separately while participants perform steady submaximal contractions.

Treatment:

Device: Transcutaneous electrical nerve stimulation

Sham

Sham Comparator group

Description:

Transient (10 s) application of transcutaneous electrical nerve stimulation applied to each leg separately while participants perform steady submaximal contractions .

Treatment:

Device: Transcutaneous electrical nerve stimulation