TENS in Persons With MS

U

University Medical Center Groningen (UMCG)

Status

Enrolling

Conditions

Multiple Sclerosis

Treatments

Device: Sham stimulation
Other: Strength training
Device: Trancutaneous Electrical Nerve Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05321927
MS-STIM

Details and patient eligibility

About

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, age between 18 and 65 years, 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 4 patient groups

Control group
Sham Comparator group
Description:
Sham stimulation will be applied over rectus femoris, tibialis anterior, the median nerve and the thenar eminence on both sides for 10 min to each limb, one at a time. Stimulation is delivered for 10 min to each limb, one at a time in three 10 minute sessions per week, for 4 weeks.
Treatment:
Device: Sham stimulation
Strength-training group
Active Comparator group
Description:
Three training sessions for 10 minutes per muscle per week, for 4 weeks during which sham stimulation will be applied.
Treatment:
Other: Strength training
Device: Sham stimulation
Trancutaneous Electrical Nerve Stimulation (TENS)
Active Comparator group
Description:
Trancutaneous Electrical Nerve Stimulation (TENS) stimulation applied over rectus femoris, tibialis anterior, the median nerve and the thenar eminence on both sides for 10 min to each limb, one at a time. Stimulation is delivered for 10 min to each limb, one at a time in three 10 minute sessions per week, for 4 weeks.
Treatment:
Device: Trancutaneous Electrical Nerve Stimulation
TENS with strength training
Experimental group
Description:
Three training sessions for 10 minutes per muscle per week, for 4 weeks during which Trancutaneous Electrical Nerve Stimulation (TENS) stimulation is applied over rectus femoris, tibialis anterior, the median nerve and the thenar eminence on both sides for 10 min to each limb, one at a time.
Treatment:
Device: Trancutaneous Electrical Nerve Stimulation
Other: Strength training

Trial contacts and locations

1

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Central trial contact

Inge CAT Zijdewind, PhD; Nikki Dreijer, MSc

Data sourced from clinicaltrials.gov

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