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

NCT03684369 | Withdrawn DMC

• 1 other identifier: UColoradoBoulder2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

walking; balance; fatigue

Outcome Measures

Primary Outcomes (6)

• Change in Gait Speed

  Time to walk 25 ft as quickly as possible

  Change from baseline at weeks 4, 8, and 12.

• Change in Walking Endurance

  Distance walked in 6 min when walking at a brisk pace

  Change from baseline at weeks 4, 8, and 12

• Change in Dynamic Balance

  Score achieved on the four components of the 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest). The maximum score for each subscale are: anticipatory = 6, reactive postural control = 6, sensory orientation = 6, dynamic gait = 10. The subscales are added to provide a total score with a maximum of 28.

  Change from baseline at weeks 4, 8, and 12

• Change in Patient Determined Disease Steps

  A questionnaire with a self-assessment scale of disease status. The scores range from 0 = normal to 8 = bedridden.

  Change from baseline at weeks 4, 8, and 12

• Change in Modified Fatigue Impact Scale

  A questionnaire that assesses the impact of fatigue experienced by persons with MS. Each of the 21 items is rated from 0 = Never to 5 = Almost always. The maximum total score = 105

  Change from baseline at weeks 4, 8, and 12.

• Change in MS Walking Scale-12

  A 12-item, patient-rated measure of how much MS compromises walking ability. Each item is rated from 1 = Not at all to 5 = extremely. The maximum total score = 60.

  Change from baseline at weeks 4, 8, and 12.

Secondary Outcomes (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.

• Change in Muscle Synergy Number

  Change from baseline at weeks 4, 8, and 12

• Change in Force Steadiness

  Change from baseline at weeks 4, 8, and 12.

Study Arms (2)

Augmented TENS

EXPERIMENTAL

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

Device: Transcutaneous electrical nerve stimulation

Sham

SHAM COMPARATOR

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

Device: Transcutaneous electrical nerve stimulation

Interventions

Transcutaneous electrical nerve stimulation DEVICE

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

Also known as: Sham transcutaneous electrical nerve stimulation

Augmented TENS; Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• University of Colorado, Denver: collaborator
• Colorado State University: collaborator

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Roger Enoka, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 25, 2018
• Study Start: July 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share