Clinical trial NCT05321927: TENS in Persons With MS
Official title: Transcutaneous Electrical Nerve Stimulation in Persons With MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 6-minute walk test
timeFrame: 6 weeks
measure: chair-stand test
timeFrame: 6 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: 6 weeks
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 6 weeks
measure: 12-item MS walking scale (MSWS-12)
timeFrame: 6 weeks
Secondary outcomes:
measure: Elbow flexor muscle force (maximal and submaximal levels)
timeFrame: 6 weeks
measure: Knee extensor muscle force (maximal and submaximal levels)
timeFrame: 6 weeks
measure: Handgrip force
timeFrame: 6 weeks
measure: Effort during submaximal contractions with elbow flexors
timeFrame: 6 weeks
measure: Effort during submaximal contractions with knee extensors
timeFrame: 6 weeks
Other outcomes:
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)
timeFrame: 6 weeks
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: UMCG
name: Inge CAT Zijdewind, PhD
role: PRINCIPAL_INVESTIGATOR
References: