NCT06432686

Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS

Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS - a Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Transcutaneous Electrical Nerve Stimulation (TENS) is a treatment that could potentially reduce walking problems and fatigue in persons with Multiple Sclerosis. However, extensive use of TENS in a clinical setting is hindered by a lack of neurophysiological understanding of the effects of TENS. The primary objective of this pilot study is therefore to investigate the effects of TENS on brain activity in pwMS measured with fMRI.

Detailed description

This study is an exploratory study to see if we can detect changes in fMRI activity during TENS in persons with MS. This is a randomized, single-blind crossover design. Subjects will undergo an MRI scan while they receive sham stimulation of the tibialis anterior, active stimulation of the tibialis anterior, stimulation of the quadriceps, perform continuous movements of the foot (plantar \& dorsiflexion) and a combination of stimulation of the tibialis anterior and movement of the foot. This study will include 15 subjects with relapsing remitting or progressive MS and 15 healthy controls. Blood-oxygen-level-dependent (BOLD) activation changes and the interaction networks before, during and after active TENS and differences in activation due to stimulation on quadriceps vs. tibialis anterior, stimulation on tibialis anterior vs plantar/dorsiflexion and stimulation on tibialis anterior vs stimulation combined with plantar/dorsiflexion. This will be compared between pwMS and healthy controls. This study can add to the limited knowledge and possibly help to personalize and implement TENS in the clinic.

Conditions

• Fatigue
• Walking, Difficulty
• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Transcutaneous Electrical Nerve Stimulation	Transcutaneous electrical nerve stimulation (TENS) is a safe, relatively cheap, and non-painful stimulation of the peripheral sensory and motor nerves. The stimulator is easy to operate and pwMS can apply the stimulation themselves at home. This makes TENS an interesting tool to augment sensory input. A high frequency and long pulse duration is used.
BEHAVIORAL	Movement	Participants are instructed to perform plantar- and dorsi-flexion contraction in a relatively slow tempo. The movement of the ankle is measured by an MRI-compatible potentiometer and participants receive feedback of this movement on the screen inside the scanner.

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-05-29
• Last updated: 2025-09-10