NCT05321927

TENS in Persons With MS

Transcutaneous Electrical Nerve Stimulation in Persons With MS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
OTHER	Strength training	Three training sessions for 10 minutes per muscle, per week, for four weeks in total.
DEVICE	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.

Timeline

• Start date: 2023-01-05
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2022-04-11
• Last updated: 2025-04-10

Locations

1 site across 1 country: Netherlands