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. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Adelante Zorggroep
Maastricht, Limburg, Netherlands
Change in executive function
response time (in ms) on the momentary digital symbol substitution task
Time frame: measured a total of 54-63 times in 30-33 weeks time
Neurocognitive test battery, change in cognitive scores
A neurocognitive test battery will be used to assess cognitive changes on various cognitive domains over time
Time frame: before and after the 12 week intervention and after a 12 week follow-up
Concentration of brain-derived neurotrophic factor (BDNF)
Brain-derived neurotrophic factor will be measured in blood of the participants
Time frame: before and after the 12 week intervention and after a 12 week follow-up
Self-perceived cognitive function
measured using the cognitive failures index (CFI), ranging from 0-100, with a higher score indicating more subjective cognitive problems
Time frame: before and after the 12 week intervention and after a 12 week follow-up
Pain score
measured using the McGill Pain Questionnaire (MPQ), ranging from 0-78, with a higher score indicating higher subjective pain level
Time frame: before and after the 12 week intervention and after a 12 week follow-up
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
Time frame: before and after the 12 week intervention and after a 12 week follow-up
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
Time frame: before and after the 12 week intervention and after a 12 week follow-up
Spasticity
measured using the Perceived Resistance to Passive Movement (PRPM) test at all four limbs.
Time frame: before and after the 12 week intervention
Electrically-evoked quadriceps strength
measured using the MicroFET2 dynamometer
Time frame: before and after the 12 week intervention
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