Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS

Sponsor
University Medical Center Groningen
Study ID
NCT06432686
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
May 29, 2024
Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Sham Comparator: sham stimulation of the tibialis anterior
  • Experimental: active stimulation of the tibialis anterior
  • Experimental: active stimulation of the quadriceps
  • Active Comparator: continuous movement of the foot (plantar & dorsiflexion)
  • Sham Comparator: a combination of sham stimulation of the tibialis anterior and movement of the foot
  • Experimental: a combination of active stimulation of the tibialis anterior and movement of the foot

Primary Outcome Measure

BOLD activation due to TENS [ Time Frame: 1 hour fMRI scan ]

Central Contacts

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