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Multiple SclerosisNCT05321927

TENS in Persons With MS

A study testing Trancutaneous Electrical Nerve Stimulation and Strength training in people with Multiple Sclerosis, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Trancutaneous Electrical Nerve Stimulation and Strength training
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteNetherlands
Study dates
5 Jan 2023to 15 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • EDSS score < 7
  • MSWS score > 30
  • FSS score > 4 or MFIS score > 38.
  • no known cardiovascular disorder or having a positive advice on a sport medical examination

Who cannot join

  • being a participant in an exercise study
  • having a psychiatric disorder
  • having cognitive or communication problems which reduces the capacity to understand instructions
  • planned a change in medication during the training period
  • having a neurological disorder other than MS
  • having cardiovascular disorders and no positive advice from a sport medical examination
  • having a pacemaker or another implantable electronic apparatus.
  • being pregnant

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Centre Groningen

    Groningen, Provincie Groningen, 9713 AW

Other trials in Netherlands

About this study

Official title: Transcutaneous Electrical Nerve Stimulation in Persons With MS

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.

Being tested
Trancutaneous Electrical Nerve Stimulation, Strength training, Sham stimulation
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trancutaneous Electrical Nerve StimulationDevice

    Also called TENS

    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.

  • Strength trainingOther

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

  • Sham stimulationDevice

    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.

Study groups in NCT05321927
Study groupRoleWhat they receive
Control groupSham comparatorSham stimulation will be applied over quadriceps femoris and biceps brachii on both sides for 10 min to each muscle group, one at a time. Stimulation is delivered for 10 min to each muscle group, in three 10 minute sessions per week, for 4 weeks.
Receives: Device: Sham stimulation
Strength-training groupActive comparatorThree training sessions for 10 minutes per muscle group per week, for 4 weeks during which sham stimulation will be applied.
Receives: Other: Strength training; Device: Sham stimulation
Trancutaneous Electrical Nerve Stimulation (TENS)Active comparatorTrancutaneous Electrical Nerve Stimulation (TENS) stimulation applied quadriceps femoris and biceps brachii on both sides for 10 min to each muscle group, one at a time. Stimulation is delivered for 10 min to each muscle group, in three 10 minute sessions per week, for 4 weeks.
Receives: Device: Trancutaneous Electrical Nerve Stimulation
TENS with strength trainingExperimentalThree training sessions for 10 minutes per target muscle group per week, for 4 weeks during which Trancutaneous Electrical Nerve Stimulation (TENS) stimulation is applied quadriceps femoris and biceps brachii on both sides.
Receives: Device: Trancutaneous Electrical Nerve Stimulation; Other: Strength training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-minute walk test

    This test assesses submaximal aerobic capactity. Subjects walk for 6 minutes starting at mark on the floor at the beginning of a 30-m long hallway and walk to the next mark at the end of the hallway as quickly as possible, but safely. The distance which is walked by the subject is measured. Subjects may use assistive devices when performing the task.

    Measured: 6 weeks

  2. chair-stand test

    This test assesses functional lower extremity strength. Subjects sit on a chair and stand up repeatedly for 30 s. Arms of the subject are crossed and held against the chest. The number of cycles of standing up from sitting are counted.

    Measured: 6 weeks

  3. Fatigue Severity Scale (FSS)

    This is a questionnaire related to the impact of fatigue on daily life. The questionnaire consists of 9 questions with a 7-point scale ranging from 'completely agree' to 'completely disagree'. The total score ranges from 9 to 63; higher scores reflect a higher impact.

    Measured: 6 weeks

  4. Modified Fatigue Impact Scale (MFIS)

    This is a questionnaire related to sense of fatigue. The questionnaire consist of 21 questions providing assessment of the effect of fatigue in terms of physical, cognitive and psychosocial function. The total score ranges from 0 to 84; higher scores reflect a higher impact of fatigue.

    Measured: 6 weeks

  5. 12-item MS walking scale (MSWS-12)

    This is a patient-base measure of walking ability. The questionnaire consists of 12 items with a 5-point scale ranging from 'not at all' to 'extremely'. The total score ranges from 5 to 60, with higher scores reflecting more walking difficulties.

    Measured: 6 weeks

Secondary outcomes (5)

  1. Elbow flexor muscle force (maximal and submaximal levels)

    Maximal voluntary force (MVC) of the elbow flexors is measured with a custom-built dynamometer. Subjects are seated in a chair with their arm abducted and in 90° of flexion with their non-dominant arm strapped to the force transducer. Subjects are instructed to contract their elbow flexors as rapidly and forcefully as possible and to maintain force generation for 5 s. MVC is determined as the peak force.

    Measured: 6 weeks

  2. Knee extensor muscle force (maximal and submaximal levels)

    Maximal voluntary force (MVC) of the knee extensors is measured with a custom-built dynamometer. Subjects are seated in a chair with the knee and hip in 90° of flexion with their non-dominant lower leg strapped to the chair's lever arm (~ 10 cm up to lateral malleolus). Subjects are instructed to contract their knee extensors as rapidly and forcefully as possible and to maintain force generation for 5 s. MVC is determined as the peak force.

    Measured: 6 weeks

  3. Handgrip force

    Maximal voluntary force (MVC) of the handgrip is measured with a hydraulic hand dynamometer (JAMAR Hand Dynamometer). The measurement is repeated 3 times and averaged.

    Measured: 6 weeks

  4. Effort during submaximal contractions with elbow flexors

    Subjects are asked to produce different submaximal force levels of the elbow flexors (20, 30, 50 and 70%) and rate their perceived effort (scale 1-10) that was needed to generate this force level.

    Measured: 6 weeks

  5. Effort during submaximal contractions with knee extensors

    Subjects are asked to produce different submaximal force levels of the knee extensors (20, 30, 50 and 70%) and rate their perceived effort (scale 1-10) that was needed to generate this force level.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start5 Jan 2023
  3. Primary completion15 Mar 2024
  4. Study completion15 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05321927
Sponsor's protocol ID
MS-STIM
Status last verified
Feb 2025
First submitted
1 Apr 2022
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dreijer N, Maffei LB, Veldman MP, Simmelink EK, Heersema DJ, Meilof JF, Zijdewind I. Transcutaneous electrical nerve stimulation improves walking in fatigued persons with multiple sclerosis: a randomized controlled trial. Ann Phys Rehabil Med. 2026 Apr;69(3):102081. doi: 10.1016/j.rehab.2025.102081. Epub 2026 Feb 11.

    PubMed 41679238

Questions about this trial

What is this clinical trial studying?

A study testing Trancutaneous Electrical Nerve Stimulation and Strength training in people with Multiple Sclerosis, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute walk test (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05321927, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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