NCT05500963

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
31mo left

Started Apr 2023

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Apr 2023Nov 2028

First Submitted

Initial submission to the registry

August 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

4.1 years

First QC Date

August 8, 2022

Last Update Submit

December 5, 2024

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

  • Fatigue

    Questionnaire scores - PROMIS Fatigue (MS) 8a

    Changes at Weeks 4, 7, and 11

  • Walking limitations

    Questionnaire scores - MS Walking Scale-12

    Changes at Weeks 4, 7, and 11

  • Walking endurance

    6-min walk test in meters

    Changes at Weeks 4, 7, and 11

  • Mobility

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

    Changes at Weeks 4, 7, and 11

Secondary Outcomes (2)

  • Quality of life questionnaire

    Changes at Weeks 4, 7, and 11

  • Muscle strength

    Changes at Weeks 4, 7, and 11

Study Arms (2)

Effective dose

EXPERIMENTAL

• 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.

Device: Transcutaneous electrical nerve stimulation

Sham dose

SHAM COMPARATOR

• 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.

Device: Transcutaneous electrical nerve stimulation

Interventions

Transcutaneous electrical nerve stimulationDEVICE

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

Effective doseSham dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Boulder, Colorado, 80309, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 34583577BACKGROUND

  • 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.

    PMID: 29366377RESULT

  • 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.

    PMID: 31715503RESULT

  • 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.

    PMID: 34710779RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Central Study Contacts

Roger Enoka, PhD

CONTACT

3034927232enoka@colorado.edu

Study Design

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

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 15, 2022

Study Start

April 25, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

November 30, 2028

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)