TENS in Persons With MS

NCT ID: NCT05321927

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2024-03-15

Brief 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

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Sham 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.

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

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.

Strength-training group

Three training sessions for 10 minutes per muscle group per week, for 4 weeks during which sham stimulation will be applied.

Group Type: ACTIVE_COMPARATOR

Strength training

Intervention Type: OTHER

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

Sham stimulation

Intervention Type: DEVICE

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.

Trancutaneous Electrical Nerve Stimulation (TENS)

Trancutaneous 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.

Group Type: ACTIVE_COMPARATOR

Trancutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

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.

TENS with strength training

Three 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.

Group Type: EXPERIMENTAL

Trancutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

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 training

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Strength training

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

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

TENS

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inge CAT Zijdewind, PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

Other Identifiers

MS-STIM

Identifier Type: -

Identifier Source: org_study_id