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Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

Primary Purpose

Multiple Sclerosis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcutaneous electrical nerve stimulation

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

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

Inclusion Criteria:

Men and women18-65 yrs
Able to read, understand, and speak English to ensure safe participation in the project
Clinical diagnosis of relapsing-remitting MS
Self-reported difficulty with walking
On stable doses of Ampyra, provigil, or other symptomatic-treating medications
No relapse or systemic steroids within the last 30 days
Able to arrange transportation to the Boulder campus

Exclusion Criteria:

Vision or hearing problems that have not been corrected
Problems with sensations to temperature, pressure, or pain
Any arm or leg problems that would influence the ability to hold a weight
Surgery to the arms or legs that continues to bother the participant
Metal implants
Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
History of head injury or stroke
Taking antidepressants, anticholinergics, stimulants, sedatives, cannabis, illicit drugs or medications to treat herpes or neurologic pain.
Diagnosis of diabetes mellitus
Poorly controlled hypertension
History of seizure disorders
≥2 alcoholic drinks/day, or present history (last 6 months) of drug abuse
Spasticity that requires the individual to change intended activities more often than once a week
Skin diseases or sensation problems in the legs or hands that influences some activities more often than once a week
Inability to attend exercise sessions 3 days per week for 6 weeks

Sites / Locations

University of ColoradoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Effective dose

Sham dose

Arm Description

• The effective dose of TENS will be set at an intensity to elicit slight contractions in each target muscle, as we have done previously. It will be delivered as 5-Hz bursts (7 pulses at 100 Hz/burst) and applied during the light exercises. The applied current (<20 mA) will differ slightly for each of the four muscle groups and will be determined while the person is standing. The current will be set at the beginning of every treatment session for both groups of participants.

• The current intensity for the sham dose will be set at sensory threshold, which will be less than that used for the effective dose. After beginning each exercise set, the current for the sham dose will decay to 0 mA within 30 s. In a preliminary study that included a sham dose of TENS, we found that only two of the experienced dancers in the sham group detected the gradual decline in TENS current from its initial value slightly above motor threshold when performing prescribed exercises.

Outcomes

Primary Outcome Measures

Fatigue

Questionnaire scores - PROMIS Fatigue (MS) 8a

Walking limitations

Questionnaire scores - MS Walking Scale-12

Walking endurance

6-min walk test in meters

Mobility

Assessment of static and dynamic balance with Mobility Lab, APDM Inc

Secondary Outcome Measures

Quality of life questionnaire

Questionnaire scores

Muscle strength

Maximal force in newtons applied by the dorsiflexors and hip flexors of each leg

Full Information

NCT ID

NCT05500963

First Posted

August 8, 2022

Last Updated

May 25, 2023

Sponsor

University of Colorado, Boulder

1. Study Identification

Unique Protocol Identification Number

NCT05500963

Brief Title

Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

Official Title

Reducing Fatigue in People With Multiple Sclerosis by Treatment With Transcutaneous Electrical Nerve Stimulation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 25, 2023 (Actual)

Primary Completion Date

March 2027 (Anticipated)

Study Completion Date

March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Colorado, Boulder

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with transcutaneous electrical nerve stimulation (TENS) at reducing the level of fatigue experienced by people with MS.

Detailed Description

We will compare the changes in self-reported levels of fatigue (symptom intensity) and measures of fatigability (work capacity) from before to after a 6-week intervention. Participants (18-65 yrs) will be randomly assigned to one of two groups: one group will receive an effective dose of TENS and the other group (control) will be given a sham dose of TENS. The treatment will be applied during 18 sessions (3x/week for 6 weeks) and delivered through electrodes placed on the skin overlying the dorsiflexor (tibialis anterior) and hip flexor (rectus femoris) muscles of both legs. Participants will be evaluated before (Week 0), during (Week 4), and after (Weeks 7 and 11) the 6-week intervention. Our long-term goal is to develop strategies that can reduce the impact of fatigue on the daily activities of persons with MS. The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with TENS at reducing the level of fatigue experienced by people with MS. Our central hypothesis is that treatment with TENS applied to selected leg muscles in people with MS will produce superior improvements in self-reported and measured levels of fatigue and fatigability compared with a sham dose of TENS.

6. Conditions and Keywords

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

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Effective dose

Arm Type

Experimental

Arm Description

Arm Title

Sham dose

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcutaneous electrical nerve stimulation

Intervention Description

Electrical stimulation applied over selected leg muscle will activate sensory receptors that will transmit signals back into the central nervous system.

Primary Outcome Measure Information:

Title

Fatigue

Description

Questionnaire scores - PROMIS Fatigue (MS) 8a

Time Frame

Changes at Weeks 4, 7, and 11

Title

Walking limitations

Description

Questionnaire scores - MS Walking Scale-12

Time Frame

Changes at Weeks 4, 7, and 11

Title

Walking endurance

Description

6-min walk test in meters

Time Frame

Changes at Weeks 4, 7, and 11

Title

Mobility

Description

Assessment of static and dynamic balance with Mobility Lab, APDM Inc

Time Frame

Changes at Weeks 4, 7, and 11

Secondary Outcome Measure Information:

Title

Quality of life questionnaire

Description

Questionnaire scores

Time Frame

Changes at Weeks 4, 7, and 11

Title

Muscle strength

Description

Maximal force in newtons applied by the dorsiflexors and hip flexors of each leg

Time Frame

Changes at Weeks 4, 7, and 11

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: Men and women18-65 yrs Able to read, understand, and speak English to ensure safe participation in the project Clinical diagnosis of relapsing-remitting MS Self-reported difficulty with walking On stable doses of Ampyra, provigil, or other symptomatic-treating medications No relapse or systemic steroids within the last 30 days Able to arrange transportation to the Boulder campus Exclusion Criteria: Vision or hearing problems that have not been corrected Problems with sensations to temperature, pressure, or pain Any arm or leg problems that would influence the ability to hold a weight Surgery to the arms or legs that continues to bother the participant Metal implants Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy History of head injury or stroke Taking antidepressants, anticholinergics, stimulants, sedatives, cannabis, illicit drugs or medications to treat herpes or neurologic pain. Diagnosis of diabetes mellitus Poorly controlled hypertension History of seizure disorders ≥2 alcoholic drinks/day, or present history (last 6 months) of drug abuse Spasticity that requires the individual to change intended activities more often than once a week Skin diseases or sensation problems in the legs or hands that influences some activities more often than once a week Inability to attend exercise sessions 3 days per week for 6 weeks

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Roger Enoka, PhD

Phone

3034927232

enoka@colorado.edu

Facility Information:

Facility Name

University of Colorado

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80309

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roger Enoka

Phone

303-492-7232

enoka@colorado.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34583577

Citation

Enoka RM, Almuklass AM, Alenazy M, Alvarez E, Duchateau J. Distinguishing between Fatigue and Fatigability in Multiple Sclerosis. Neurorehabil Neural Repair. 2021 Nov;35(11):960-973. doi: 10.1177/15459683211046257. Epub 2021 Sep 28.

Results Reference

background

PubMed Identifier

29366377

Citation

Almuklass AM, Davis L, Hamilton LD, Hebert JR, Alvarez E, Enoka RM. Pulse Width Does Not Influence the Gains Achieved With Neuromuscular Electrical Stimulation in People With Multiple Sclerosis: Double-Blind, Randomized Trial. Neurorehabil Neural Repair. 2018 Jan;32(1):84-93. doi: 10.1177/1545968317753681. Epub 2018 Jan 24.

Results Reference

result

PubMed Identifier

31715503

Citation

Almuklass AM, Capobianco RA, Feeney DF, Alvarez E, Enoka RM. Sensory nerve stimulation causes an immediate improvement in motor function of persons with multiple sclerosis: A pilot study. Mult Scler Relat Disord. 2020 Feb;38:101508. doi: 10.1016/j.msard.2019.101508. Epub 2019 Nov 6.

Results Reference

result

PubMed Identifier

34710779

Citation

Alenazy M, Daneshgar Asl S, Petrigna L, Feka K, Alvarez E, Almuklass AM, Enoka RM. Treatment with electrical stimulation of sensory nerves improves motor function and disability status in persons with multiple sclerosis: A pilot study. J Electromyogr Kinesiol. 2021 Dec;61:102607. doi: 10.1016/j.jelekin.2021.102607. Epub 2021 Oct 13.

Results Reference

result

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Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

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