TENS in Persons With MS

NCT05321927 | Completed

• 1 other identifier: MS-STIM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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.

  6 weeks

• 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.

  6 weeks

• 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.

  6 weeks

• 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.

  6 weeks

• 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.

  6 weeks

Secondary Outcomes (5)

• Elbow flexor muscle force (maximal and submaximal levels)

  6 weeks

• Knee extensor muscle force (maximal and submaximal levels)

  6 weeks

• Handgrip force

  6 weeks

• Effort during submaximal contractions with elbow flexors

  6 weeks

• Effort during submaximal contractions with knee extensors

  6 weeks

Other Outcomes (1)

• Multiple Sclerosis Quality of Life-54 (MSQOL-54)

  6 weeks

Study Arms (4)

Control group

SHAM COMPARATOR

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.

Device: Sham stimulation

Strength-training group

ACTIVE COMPARATOR

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

Other: Strength training; Device: Sham stimulation

Trancutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR

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.

Device: Trancutaneous Electrical Nerve Stimulation

TENS with strength training

EXPERIMENTAL

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.

Device: Trancutaneous Electrical Nerve Stimulation; Other: Strength training

Interventions

Trancutaneous Electrical Nerve Stimulation 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.

Also known as: TENS

TENS with strength training; Trancutaneous Electrical Nerve Stimulation (TENS)

Strength training OTHER

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

Strength-training group; TENS with strength training

Sham stimulation 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.

Control group; Strength-training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713 AW, Netherlands

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcutaneous Electric Nerve Stimulation; Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Inge CAT Zijdewind, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 11, 2022
• Study Start: January 5, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)