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Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS

ConditionsFatigueWalking, DifficultyMultiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age: 18-65 years

EDSS score < 7

Disqualifiers

metal or electrical implants

BMI > 40

claustrophobia

being pregnant

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

30 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: sham stimulation of the tibialis anteriorSham comparator 1 intervention
Group B: active stimulation of the tibialis anteriorExperimental treatment 1 intervention
Group C: active stimulation of the quadricepsExperimental treatment 1 intervention
Group D: continuous movement of the foot (plantar & dorsiflexion)Active comparator 1 intervention
Group E: a combination of sham stimulation of the tibialis anterior and movement of the footSham comparator 2 interventions
Group F: a combination of active stimulation of the tibialis anterior and movement of the footExperimental treatment 2 interventions

Trial outcomes

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).

Time frame
1 hour fMRI scan

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: