Clinical trial NCT06432686: Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS
Official title: Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS - a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatigue
Walking, Difficulty
Multiple Sclerosis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: * 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: BOLD activation due to TENS
timeFrame: 1 hour fMRI scan
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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