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

Primary Purpose

Multiple Sclerosis

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Transcutaneous electrical nerve stimulation

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring walking, balance, fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Augmented TENS

Sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Gait Speed

Time to walk 25 ft as quickly as possible

Change in Walking Endurance

Distance walked in 6 min when walking at a brisk pace

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 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 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 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.

Secondary Outcome Measures

Change in Romberg Quotient

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.

Change Conditioned H-reflex Amplitude

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.

Change in Proprioception Tract

Change in MRI signal intensity in corticospinal tract

Change in Muscle Synergy Number

Non-negative matrix factorization will be used to identify the number of muscle synergies when subjects walk on a treadmill.

Change in Force Steadiness

The coefficient of variation for force when subjects perform steady, submaximal contractions.

Change in Muscle Synergy TIming

The timing of the muscle synergies when subjects walk on a treadmill.

Change in Discharge characteristics

The mean and coefficient of variation for the times between action potentials during steady isometric contractions.

Full Information

NCT ID

NCT03684369

First Posted

August 24, 2018

Last Updated

November 4, 2020

Sponsor

University of Colorado, Boulder

Collaborators

University of Colorado, Denver, Colorado State University

1. Study Identification

Unique Protocol Identification Number

NCT03684369

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Withdrawn

Why Stopped

The project was not funded.

Study Start Date

July 2020 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Colorado, Boulder

Collaborators

University of Colorado, Denver, Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

walking, balance, fatigue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Augmented TENS

Arm Type

Experimental

Arm Description

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

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Transcutaneous electrical nerve stimulation

Other Intervention Name(s)

Sham transcutaneous electrical nerve stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Gait Speed

Description

Time to walk 25 ft as quickly as possible

Time Frame

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

Title

Change in Walking Endurance

Description

Distance walked in 6 min when walking at a brisk pace

Time Frame

Change from baseline at weeks 4, 8, and 12

Title

Change in Dynamic Balance

Description

Time Frame

Change from baseline at weeks 4, 8, and 12

Title

Change in Patient Determined Disease Steps

Description

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

Time Frame

Change from baseline at weeks 4, 8, and 12

Title

Change in Modified Fatigue Impact Scale

Description

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

Time Frame

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

Title

Change in MS Walking Scale-12

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Romberg Quotient

Description

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.

Time Frame

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

Title

Change Conditioned H-reflex Amplitude

Description

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.

Time Frame

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

Title

Change in Proprioception Tract

Description

Change in MRI signal intensity in corticospinal tract

Time Frame

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

Title

Change in Muscle Synergy Number

Description

Non-negative matrix factorization will be used to identify the number of muscle synergies when subjects walk on a treadmill.

Time Frame

Change from baseline at weeks 4, 8, and 12

Title

Change in Force Steadiness

Description

The coefficient of variation for force when subjects perform steady, submaximal contractions.

Time Frame

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

Title

Change in Muscle Synergy TIming

Description

The timing of the muscle synergies when subjects walk on a treadmill.

Time Frame

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

Title

Change in Discharge characteristics

Description

The mean and coefficient of variation for the times between action potentials during steady isometric contractions.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger Enoka, PhD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share the data obtained by individual participants.

Learn more about this trial

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

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