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TENS in Persons With MS

NCT05321927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-04-10

No results posted yet for this study

Summary

Persons with multiple sclerosis (pwMS) often have an increased sense of fatigue. Furthermore, they present walking difficulties which negatively affects their mobility and results in an additional increase of fatigue. Previous literature suggests that transcutaneous electrical nerve stimulation (TENS) of leg muscles might increase their walking capacity and decrease perception of fatigue. In the present study we aim to investigate whether TENS of leg muscles reduces walking difficulties and sense of fatigue in pwMS in comparison with a short strength training protocol or no training. A similar aim is addressed after TENS of elbow flexor muscles.

Subjects with relapsing remitting or progressive MS, will undergo transcutaneous electrical nerve stimulation (TENS), strength exercises (SExerc), both TENS and SExerc (COMB) simultaneously, or sham stimulation without training (CON) of both leg and arm muscles. Force and fatigue measurements are performed before, directly after and three weeks after the training sessions and contain walking, fatigue, and strength assessments.

Main study parameters are changes in the scores of i) the six-minute walking test (6-MWT), ii) the perceived walking disability (MSWS-12) and iii) fatigue questionnaires (FSS and MFIS). Additional study parameters are changes in muscle force and muscle fatigability.

Conditions

Interventions

DEVICE

Trancutaneous Electrical Nerve Stimulation

Transcutaneous Electrical Nerve Stimulation produces an electrical current to stimulate the nerves for therapeutic purposes. continuous high frequency (≥ 50 Hz) stimulation for 5 minutes followed by high frequency (≥ 50 Hz) bursts with 7 pulses per burst for the last 5 minutes.

OTHER

Strength training

Three training sessions for 10 minutes per muscle, per week, for four weeks in total.

DEVICE

Sham stimulation

Continuous stimulation at 1 Hz for 2 seconds, then no stimulation for 10 seconds. This will alternate for 10 minutes. The intensity equals the intensity that is just felt by the individual.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Inge CAT Zijdewind, PhD · UMCG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2024-03-15
Completion
2024-03-15

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321927 on ClinicalTrials.gov