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

NCT ID: NCT03684369

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed 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.

Conditions

Multiple Sclerosis

Keywords

walking; balance; fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Augmented TENS

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

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

Commercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions.

Sham

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

Group Type: SHAM_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

Commercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions.

Interventions

Transcutaneous electrical nerve stimulation

Commercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions.

Intervention Type: DEVICE

Other Intervention Names

Sham transcutaneous electrical nerve stimulation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: collaborator

University of Colorado, Boulder

OTHER

Sponsor Role: lead

Responsible Party

Roger Enoka

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roger Enoka, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Other Identifiers

UColoradoBoulder2

Identifier Type: -

Identifier Source: org_study_id