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Spinal Cord InjuriesNCT05822297

SCED Myokines and Cognition in SCI

A study testing Neuromuscular electrical stimulation in people with Spinal Cord Injuries and Cognitive Decline, run by Adelante, Centre of Expertise in Rehabilitation and Audiology at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rationale: Individuals with spinal cord injury (SCI) suffer from accelerated cognitive aging. In able-bodied individuals, a vast amount of studies have shown that exercise interventions can improve cognitive function. Myokines (i.e. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries, Cognitive Decline
What is being tested?
Neuromuscular electrical stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteNetherlands
Study dates
24 Jan 2024to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Persons with spinal cord injury
  • Completeness of injury: American Spinal Injury Association (ASIA) Impairment Scale (AIS) A, B or C
  • Level of injury: L2 or higher
  • At least 18 years old
  • Chronic stage (> 1 year) since injury
  • No previous surgery to the quadriceps muscles
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  • Intact hand function
  • Able to use apps on smartphone (i.e. participants should have their own smartphone and should not have disabilities that impair them to operate it independently)
  • Able to follow the instructions of placing the surface electrodes of the NMES device correctly or to have someone else put the electrodes for them
  • Dutch as a native language

Who cannot join

  • Malignant processes, or history of undergoing chemotherapy, or history of radiotherapy to the head
  • No visible or palpable contraction of the quadriceps muscle upon electrical stimulation
  • Intolerance to electrical stimulation of the quadriceps muscle
  • Recent or current participation in an electrical stimulation-induced exercise or therapy program in which regular electrical stimulation was given (up to 6 months prior to study inclusion)
  • Known neurodegenerative disorder, such as Alzheimer's disease or Parkinson's disease
  • Known psychiatric disorder, such as major depressive disorder or bipolar disorder
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  • Current pressure ulcer
  • History of severe autonomic dysreflexia
  • Metal implants in the electrical stimulation area
  • Intrathecal baclofen (ITB) device
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Adelante Zorggroep

    Maastricht, Limburg, 6430 AB

Other trials in Netherlands

About this study

Official title: Myokines and Cognitive Aging in People With Spinal Cord Injury: a Single Case Experimental Design Study

Rationale: Individuals with spinal cord injury (SCI) suffer from accelerated cognitive aging. In able-bodied individuals, a vast amount of studies have shown that exercise interventions can improve cognitive function. Myokines (i.e. factors released into the blood stream from muscle cells) are considered one of the mediators of this beneficial effect. Neuromuscular electrical stimulation (NMES), used to replace or support muscle training in disabled individuals with poor exercise possibilities, was shown to elicit a large release of myokines (in some studies larger than following voluntary exercise). However, so far, the effects of NMES on cognitive function have never been studied before. In fact, only one study has previously investigated the effect of exercise on cognitive function in persons with SCI.

Objective: The primary aim is to assess to what extent a 12 week intervention with NMES to the quadriceps muscles of people with SCI can change their performance on a set of cognitive tests. Secondarily, the investigators will measure to what extent NMES to the quadriceps muscles of people with SCI induces changes in blood levels of the myokine brain-derived neurotrophic factor (BDNF), which is considered a potential mediator of the exercise-cognition effect, facilitating neuroplastic processes.

Read more

Study design: A single case experimental design (SCED) with sequential multiple baseline time series and a single-armed prospective study design, with a random duration of the baseline phase ranging from 3 to 6 weeks, an intervention phase of 12 weeks, and a 12 week period without measurements, followed by a follow-up phase of 3 weeks; in addition to a single-armed prospective study design.

Study population: Individuals (n = 15) aged 18 years and older with a chronic SCI (>1y post-injury) and with visible or palpable contraction of the quadriceps muscles upon NMES will be recruited at the rehabilitation centre of Adelante in Hoensbroek, the Netherlands.

Intervention: The study participants will receive 30min of NMES using surface electrodes on the quadriceps muscles three times per week for a total duration of 12 weeks.

Main study parameters/endpoints: The primary outcome is cognitive function changes which will be measured using a secured smartphone application (e.g. m-Path). Secondary outcome measures are changes in the blood myokine levels of BDNF and changes in cognitive outcome scores on an verbal cognitive test battery.

Being tested
Neuromuscular electrical stimulation
Keywords
Aging, Myokine, Cognition, Spinal cord injury, Neuromuscular electrical stimulation
Medical subject headings
Spinal Cord Injuries, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular electrical stimulationDevice

    NMES will consist of a 12 week electrical stimulation program, three times a week. Electrical stimulation will be done on the quadriceps muscles of both legs simultaneously. For each leg, one electrode is placed on the proximal side and one on the distal side of the quadriceps muscle. Electrical stimulation sessions will take 30min, at a stimulation frequency of 50Hz, an intensity where we can at least see a visible or palpable contraction with a maximum intensity of 100mA (we will choose the highest intensity that is easily supported by the participant without inducing discomfort) and a pulse width of 400μs. The activation within the activation-rest cycle consists of a 1s ramp-up, 7s full activation and 1s ramp-down, followed by 18s rest. Every 4 weeks the rest period will be diminished with 3s until a total of 9s.

Study groups in NCT05822297
Study groupRoleWhat they receive
All participantsExperimentalEach participant will undergo the same procedures and intervention, consisting of a baseline phase, intervention phase and follow-up phase. The length of the baseline phase will be randomized 3, 4, 5 or 6 weeks.
Receives: Device: Neuromuscular electrical stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in executive function

    response time (in ms) on the momentary digital symbol substitution task

    Measured: measured a total of 54-63 times in 30-33 weeks time

Secondary outcomes (8)

  1. Neurocognitive test battery, change in cognitive scores

    A neurocognitive test battery will be used to assess cognitive changes on various cognitive domains over time

    Measured: before and after the 12 week intervention and after a 12 week follow-up

  2. Concentration of brain-derived neurotrophic factor (BDNF)

    Brain-derived neurotrophic factor will be measured in blood of the participants

    Measured: before and after the 12 week intervention and after a 12 week follow-up

  3. Self-perceived cognitive function

    measured using the cognitive failures index (CFI), ranging from 0-100, with a higher score indicating more subjective cognitive problems

    Measured: before and after the 12 week intervention and after a 12 week follow-up

  4. Pain score

    measured using the McGill Pain Questionnaire (MPQ), ranging from 0-78, with a higher score indicating higher subjective pain level

    Measured: before and after the 12 week intervention and after a 12 week follow-up

  5. Fatigue

    measured using the Fatigue Severity Scale (FSS), ranging from 1-7, with a higher score indicating more fatigue/higher impact of fatigue on daily activities

    Measured: before and after the 12 week intervention and after a 12 week follow-up

  6. Participation in daily life activities

    measured using the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P), ranging from 0-100, with a higher score indicating larger participation in daily life activities

    Measured: before and after the 12 week intervention and after a 12 week follow-up

  7. Spasticity

    measured using the Perceived Resistance to Passive Movement (PRPM) test at all four limbs.

    Measured: before and after the 12 week intervention

  8. Electrically-evoked quadriceps strength

    measured using the MicroFET2 dynamometer

    Measured: before and after the 12 week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start24 Jan 2024
  3. Primary completion22 Jul 2025
  4. Study completion1 Oct 2025

Resources

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
Not applicable
Intervention model
Single group
Model description
A single case experimental design (SCED) with sequential multiple baseline time series and a single-armed prospective study design, with a random duration of the baseline phase ranging from 3 to 6 weeks, an intervention phase of 12 weeks, and a 12 week period without measurements, followed by a follow-up phase of 3 weeks; in addition to a single-armed prospective study design.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822297
Sponsor's protocol ID
CoBes22.055
Status last verified
Jul 2026
First submitted
7 Apr 2023
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All information will be coded and kept behind locked doors.

Publications

  • Vints WAJ, Levin O, van Griensven M, Vlaeyen JWS, Masiulis N, Verbunt J, van Laake-Geelen CCM. Neuromuscular electrical stimulation to combat cognitive aging in people with spinal cord injury: protocol for a single case experimental design study. BMC Neurol. 2024 Jun 11;24(1):197. doi: 10.1186/s12883-024-03699-9.

    PubMed 38862912

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular electrical stimulation in people with Spinal Cord Injuries and Cognitive Decline, run by Adelante, Centre of Expertise in Rehabilitation and Audiology at 1 site in Netherlands.

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 10 inclusion and 11 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: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in executive function (time frame: measured a total of 54-63 times in 30-33 weeks time). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822297, which also lists 1 linked publication.

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 16 Jul 2026.

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SCED Myokines and Cognition in SCI (NCT05822297) | AzTrials