FatigueNCT06432686
Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS
A study testing Transcutaneous Electrical Nerve Stimulation and Movement in people with Fatigue and Walking, Difficulty, run by University Medical Center Groningen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Walking, Difficulty, Multiple Sclerosis
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation and Movement
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age: 18-65 years
- EDSS score < 7
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Inge Zijdewind contact
About this study
Official title: Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS - a Pilot Study
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.
Read the 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.
- Conditions
- Fatigue, Walking, Difficulty, Multiple Sclerosis
- Being tested
- Transcutaneous Electrical Nerve Stimulation, Movement
- Medical subject headings
- Fatigue, Mobility Limitation, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
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.
MovementBehavioural
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 group | Role | What they receive |
|---|---|---|
| sham stimulation of the tibialis anterior | Sham comparator | Not described Receives: Device: Transcutaneous Electrical Nerve Stimulation |
| active stimulation of the tibialis anterior | Experimental | Not described Receives: Device: Transcutaneous Electrical Nerve Stimulation |
| active stimulation of the quadriceps | Experimental | Not described Receives: Device: Transcutaneous Electrical Nerve Stimulation |
| continuous movement of the foot (plantar & dorsiflexion) | Active comparator | Not described Receives: Behavioral: Movement |
| a combination of sham stimulation of the tibialis anterior and movement of the foot | Sham comparator | Not described Receives: Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Movement |
| a combination of active stimulation of the tibialis anterior and movement of the foot | Experimental | Not described Receives: Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 hour fMRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432686
- Sponsor's protocol ID
- MS-fMRI-TENS
- Status last verified
- Sep 2025
- First submitted
- 22 May 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS - a Pilot Study
- ClinicalTrials.gov ID
- NCT06432686
- Acronym / sponsor ID
- MS-fMRI-TENS
- Conditions
- Fatigue, Walking, Difficulty, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age: 18-65 years
- EDSS score < 7
Key exclusion criteria (8 listed)
- metal or electrical implants
- BMI > 40
- claustrophobia
- being pregnant
- having a psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationTranscutaneous 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. | Device | 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 |
| MovementParticipants 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. | Behavioural | 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) |
Primary outcome
BOLD activation due to TENS
Time frame: 1 hour fMRI scan
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inge Zijdewind contact
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation and Movement in people with Fatigue and Walking, Difficulty, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikki Dreijer (0625647172, n.dreijer@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD activation due to TENS (time frame: 1 hour fMRI scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.