Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS

University Medical Center Groningen (UMCG)

Status: Not yet enrolling

Conditions: Multiple Sclerosis; Walking, Difficulty; Fatigue

Treatments: Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Movement

Study type: Interventional

Funder types: Other

Identifiers

NCT06432686

MS-fMRI-TENS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 6 patient groups

sham stimulation of the tibialis anterior

Sham Comparator group

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

active stimulation of the tibialis anterior

Experimental group

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

active stimulation of the quadriceps

Experimental group

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

continuous movement of the foot (plantar & dorsiflexion)

Active Comparator group

Treatment:

Behavioral: Movement

a combination of sham stimulation of the tibialis anterior and movement of the foot

Sham Comparator group

Treatment:

Behavioral: Movement

Device: Transcutaneous Electrical Nerve Stimulation

a combination of active stimulation of the tibialis anterior and movement of the foot

Experimental group

Treatment:

Behavioral: Movement

Device: Transcutaneous Electrical Nerve Stimulation