Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05822297
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-04-07
Brief Title:
SCED Myokines and Cognition in SCI
Sponsor:
Adelante Centre of Expertise in Rehabilitation and Audiology
Organization:
Adelante Centre of Expertise in Rehabilitation and Audiology
Study Overview
Official Title:
Myokines and Cognitive Aging in People With Spinal Cord Injury a Single Case Experimental Design Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 parametersendpoints The primary outcome is cognitive function changes which will be measured using a secured smartphone application eg 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
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 parametersendpoints The primary outcome is cognitive function changes which will be measured using a secured smartphone application eg 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None