Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS

NCT06432686 | Not Yet Recruiting DMC

• 1 other identifier: MS-fMRI-TENS
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fatigue; Walking, Difficulty; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• BOLD activation due to TENS

  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).

  1 hour fMRI scan

Study Arms (6)

sham stimulation of the tibialis anterior

SHAM COMPARATOR

Device: Transcutaneous Electrical Nerve Stimulation

active stimulation of the tibialis anterior

EXPERIMENTAL

Device: Transcutaneous Electrical Nerve Stimulation

active stimulation of the quadriceps

EXPERIMENTAL

Device: Transcutaneous Electrical Nerve Stimulation

continuous movement of the foot (plantar & dorsiflexion)

ACTIVE COMPARATOR

Behavioral: Movement

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

SHAM COMPARATOR

Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Movement

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

EXPERIMENTAL

Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Movement

Interventions

Transcutaneous Electrical Nerve Stimulation 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.

a combination of active stimulation of the tibialis anterior and movement of the foot; a combination of sham stimulation of the tibialis anterior and movement of the foot; active stimulation of the quadriceps; active stimulation of the tibialis anterior; sham stimulation of the tibialis anterior

Movement 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; a combination of sham stimulation of the tibialis anterior and movement of the foot; continuous movement of the foot (plantar & dorsiflexion)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age: 18-65 years
• EDSS score \< 7

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Fatigue; Mobility Limitation; Multiple Sclerosis

Interventions

Transcutaneous Electric Nerve Stimulation; Movement

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Nikki Dreijer

CONTACT

0625647172; n.dreijer@umcg.nl

Inge Zijdewind

CONTACT

c.a.t.zijdewind@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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.

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09