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

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ClinicalTrials.gov Identifier: NCT03684369
Recruitment Status : Withdrawn (The project was not funded.)
First Posted : September 25, 2018
Last Update Posted : November 6, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
Colorado State University
Information provided by (Responsible Party):
Roger Enoka, University of Colorado, Boulder

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Transcutaneous electrical nerve stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Augmented TENS
Transcutaneous electrical nerve stimulation applied to each leg separately while participants perform steady submaximal contractions.
Device: 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.
Other Name: Sham transcutaneous electrical nerve stimulation

Sham Comparator: Sham
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
Commercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions.
Other Name: Sham transcutaneous electrical nerve stimulation




Primary Outcome Measures :
  1. Change in Gait Speed [ Time Frame: Change from baseline at weeks 4, 8, and 12. ]
    Time to walk 25 ft as quickly as possible

  2. Change in Walking Endurance [ Time Frame: Change from baseline at weeks 4, 8, and 12 ]
    Distance walked in 6 min when walking at a brisk pace

  3. Change in Dynamic Balance [ Time Frame: Change from baseline at weeks 4, 8, and 12 ]
    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.

  4. Change in Patient Determined Disease Steps [ Time Frame: Change from baseline at weeks 4, 8, and 12 ]
    A questionnaire with a self-assessment scale of disease status. The scores range from 0 = normal to 8 = bedridden.

  5. Change in Modified Fatigue Impact Scale [ Time Frame: Change from baseline at weeks 4, 8, and 12. ]
    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

  6. Change in MS Walking Scale-12 [ Time Frame: Change from baseline at weeks 4, 8, and 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.


Secondary Outcome Measures :
  1. Change in Romberg Quotient [ Time Frame: Change from baseline at weeks 4, 8, and 12. ]
    Ratio of the total sway area when standing with the eyes closed relative to that when the eyes are open. The test will be performed while standing on a firm surface and a foam surface.

  2. Change Conditioned H-reflex Amplitude [ Time Frame: Change from baseline at weeks 4, 8, and 12. ]
    Comparison of the percent reduction in the amplitude of the conditioned H-reflex amplitude in soleus while seated, standing with eyes open, and standing with eyes closed.

  3. Change in Proprioception Tract [ Time Frame: Change from baseline at weeks 4, 8, and 12. ]
    Change in MRI signal intensity in corticospinal tract

  4. Change in Muscle Synergy Number [ Time Frame: Change from baseline at weeks 4, 8, and 12 ]
    Non-negative matrix factorization will be used to identify the number of muscle synergies when subjects walk on a treadmill.

  5. Change in Force Steadiness [ Time Frame: Change from baseline at weeks 4, 8, and 12. ]
    The coefficient of variation for force when subjects perform steady, submaximal contractions.

  6. Change in Muscle Synergy TIming [ Time Frame: Change from baseline at weeks 4, 8, and 12. ]
    The timing of the muscle synergies when subjects walk on a treadmill.

  7. Change in Discharge characteristics [ Time Frame: Change from baseline at weeks 4, 8, and 12. ]
    The mean and coefficient of variation for the times between action potentials during steady isometric contractions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684369


Sponsors and Collaborators
University of Colorado, Boulder
University of Colorado, Denver
Colorado State University
Investigators
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Principal Investigator: Roger Enoka, PhD University of Colorado, Denver
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Responsible Party: Roger Enoka, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03684369    
Other Study ID Numbers: UColoradoBoulder2
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share the data obtained by individual participants.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roger Enoka, University of Colorado, Boulder:
walking
balance
fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases