Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS

Not Applicable

Not yet recruiting

• Conditions: Fatigue; Walking, Difficulty; Multiple Sclerosis
• Interventions: Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Movement

• Registration Number: NCT06432686
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-29
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Study Start: 2024-07-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age: 18-65 years
• EDSS score < 7

Exclusion Criteria

• metal or electrical implants
• BMI > 40
• claustrophobia
• being pregnant
• having a psychiatric disorder
• having cognitive or communication problems which reduces the capacity to understand instructions
• having a neurological disorder other than MS
• having cardiac arrhythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
a combination of sham stimulation of the tibialis anterior and movement of the foot	Movement	-
sham stimulation of the tibialis anterior	Transcutaneous Electrical Nerve Stimulation	-
active stimulation of the tibialis anterior	Transcutaneous Electrical Nerve Stimulation	-
active stimulation of the quadriceps	Transcutaneous Electrical Nerve Stimulation	-
a combination of active stimulation of the tibialis anterior and movement of the foot	Transcutaneous Electrical Nerve Stimulation	-
continuous movement of the foot (plantar & dorsiflexion)	Movement	-
a combination of sham stimulation of the tibialis anterior and movement of the foot	Transcutaneous Electrical Nerve Stimulation	-
a combination of active stimulation of the tibialis anterior and movement of the foot	Movement	-

Primary Outcome Measures

Name	Time	Method
BOLD activation due to TENS	1 hour fMRI scan	Blood level detection activation (BOLD) changes and 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. We focus on the thalamus (integration station of sensory input), sensory cortex (sensory awareness) and motor cortices (sensorimotor integration).