Clinical trial NCT03684369: Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy
Official title: Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: walking
balance
fatigue
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Colorado State University
First posted: 2018-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Gait Speed
timeFrame: Change from baseline at weeks 4, 8, and 12.
measure: Change in Walking Endurance
timeFrame: Change from baseline at weeks 4, 8, and 12
measure: Change in Dynamic Balance
timeFrame: Change from baseline at weeks 4, 8, and 12
measure: Change in Patient Determined Disease Steps
timeFrame: Change from baseline at weeks 4, 8, and 12
measure: Change in Modified Fatigue Impact Scale
timeFrame: Change from baseline at weeks 4, 8, and 12.
measure: Change in MS Walking Scale-12
timeFrame: Change from baseline at weeks 4, 8, and 12.
Secondary outcomes:
measure: Change in Romberg Quotient
timeFrame: Change from baseline at weeks 4, 8, and 12.
measure: Change Conditioned H-reflex Amplitude
timeFrame: Change from baseline at weeks 4, 8, and 12.
measure: Change in Proprioception Tract
timeFrame: Change from baseline at weeks 4, 8, and 12.
measure: Change in Muscle Synergy Number
timeFrame: Change from baseline at weeks 4, 8, and 12
measure: Change in Force Steadiness
timeFrame: Change from baseline at weeks 4, 8, and 12.
measure: Change in Muscle Synergy TIming
timeFrame: Change from baseline at weeks 4, 8, and 12.
measure: Change in Discharge characteristics
timeFrame: Change from baseline at weeks 4, 8, and 12.
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Roger Enoka, PhD
role: PRINCIPAL_INVESTIGATOR
References: