Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Fatigue Walking, Difficulty Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

* sham stimulation of the tibialis anterior,
* active stimulation of the tibialis anterior,
* active stimulation of the quadriceps,
* continuous movement of the foot (plantar \& dorsiflexion),
* a combination of sham stimulation of the tibialis anterior and movement of the foot,
* a combination of stimulation of the tibialis anterior and movement of the foot.

The order of these conditions is randomized.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

All participants receive both active and sham TENS. Subjects will be told they will get two types of stimulation but they are not being told that one is 'sham' and the other 'active', to minimalize a placebo effect. Researchers are not blinded, but also interacting minimally with the participant while they are lying in the scanner.

Study Groups

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sham stimulation of the tibialis anterior

Group Type SHAM_COMPARATOR

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

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.

active stimulation of the tibialis anterior

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

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.

active stimulation of the quadriceps

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

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.

continuous movement of the foot (plantar & dorsiflexion)

Group Type ACTIVE_COMPARATOR

Movement

Intervention Type BEHAVIORAL

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.

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

Group Type SHAM_COMPARATOR

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

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.

Movement

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

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.

Movement

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes