To assess to what extent a 12 weeks intervention consisting of Neuromuscular electrical stimulation (NMES) to the quadriceps muscles may change cognitive function and blood levels of the biomarker Brain-derived neurotrophic factor (BDNF) in persons…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Response time and %accuracy on an executive function task
Secondary outcome
A cognitive test battery and blood collection for the assessment of
Brain-derived neurotrophic factor (BDNF) levels. Other measured variables are
important for taking into account potential moderating effects.
Background summary
Individuals with spinal cord injury (SCI) suffer from accelerated cognitive
aging. Brain-derived neurotrophic factor (BDNF) is a facilitator of
neuroplastic processes, which is released from contracting muscles. In healthy
older adults it is the suggested mechanism of exercise-induced cognitive
improvements. Neuromuscular electrical stimulation (NMES) has the potential to
induce BDNF and induce cognitive improvements in people with SCI.
Study objective
To assess to what extent a 12 weeks intervention consisting of Neuromuscular
electrical stimulation (NMES) to the quadriceps muscles may change cognitive
function and blood levels of the biomarker Brain-derived neurotrophic factor
(BDNF) in persons with spinal cord injury.
Study design
Single center, single case experimental design with a single-armed prospective
study design
Intervention
Neuromuscular electrical stimulation
Study burden and risks
Every participant will be asked to visit the research center 5 times. The
intervention consists of 12 weeks of 3x30min per week of neuromuscular
electrical stimulation and cognitive tests 3x30sec per week for 18-21 weeks.
The electrical stimulation is being used as intended, and has therefore a low
risk of injury.
P. Debyelaan 25
Maastricht 6229 hx
NL
P. Debyelaan 25
Maastricht 6229 hx
NL
Listed location countries
Age
Inclusion criteria
-Persons with spinal cord injury
-Completeness of injury: 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
-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
-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
-Current pressure ulcer
-History of severe autonomic dysreflexia
-Metal implants in the electrical stimulation area
-Intrathecal baclofen (ITB) device
-Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05822297 |
| CCMO | NL84287.015.23 |