Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
15 participants
INTERVENTIONAL
2024-01-31
2024-09-30
Brief Summary
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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.
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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All participants
Each 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.
Neuromuscular electrical stimulation
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.
Interventions
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Neuromuscular electrical stimulation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* Current pressure ulcer
* History of severe autonomic dysreflexia
* Metal implants in the electrical stimulation area
* Intrathecal baclofen (ITB) device
* Pregnancy
18 Years
ALL
No
Sponsors
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Adelante, Centre of Expertise in Rehabilitation and Audiology
OTHER
Responsible Party
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Wouter Vints
Principal Investigator
Principal Investigators
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Charlotte van Laake, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Center of Exertise in Rehabilitation and Audiology, Adelante Zorggroep
Locations
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Adelante Zorggroep
Maastricht, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Wouter Vints, MD
Role: primary
Charlotte van Laake, MD, PhD
Role: backup
References
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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.
Other Identifiers
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CoBes22.055
Identifier Type: -
Identifier Source: org_study_id