Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536634
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAES
Brief Summary:
The goal for this project is to investigate the effects of a 5-week SAES therapy in addition to conventional therapy on both behavioural sensory and motor and neurological measures and the underlying mechanisms of treatment response
The goal of this project to investigate the effects of a 5-week SAES therapy in addition to conventional therapy
The aim is to investigate whether SAES is more effective than conventional therapy alone in children with hemiparesis The investigators will assess the efficacy of SAES using novel clinical assessment such as kinematic evaluations and modern neurophysiological measures namely transcranial magnetic stimulation TMS and resting-state functional MRI rs-fMRI
It will be expected a benefit for children with hemiparesis after SAES training which may lead to improved bimanual and unimanual functions Benefits have been reported in adults and in preliminary studies also in children
Type of study Randomised controlled clinical trial
Participants with hemiparesis will be included in the study The study group will receive the SAES training with a glove or adhesive electrodes as a home-based training during 30 minutes per day 5xweek for 5 weeks combined with conventional occupation therapy
Researchers will compare the SAES group with a group of patients with comparable conditions who receive the prescribed conventional occupational therapy andor physiotherapy treatment as usual TAU
The goal of this project to investigate the effects of a 5-week SAES therapy in addition to conventional therapy
The aim is to investigate whether SAES is more effective than conventional therapy alone in children with hemiparesis The investigators will assess the efficacy of SAES using novel clinical assessment such as kinematic evaluations and modern neurophysiological measures namely transcranial magnetic stimulation TMS and resting-state functional MRI rs-fMRI
It will be expected a benefit for children with hemiparesis after SAES training which may lead to improved bimanual and unimanual functions Benefits have been reported in adults and in preliminary studies also in children
Type of study Randomised controlled clinical trial
Participants with hemiparesis will be included in the study The study group will receive the SAES training with a glove or adhesive electrodes as a home-based training during 30 minutes per day 5xweek for 5 weeks combined with conventional occupation therapy
Researchers will compare the SAES group with a group of patients with comparable conditions who receive the prescribed conventional occupational therapy andor physiotherapy treatment as usual TAU
Detailed Description:
Children with hemiparesis present with sensory and motor deficits which negatively affect quality of life and decrease participation in everyday life To date no treatment is yet effective to decrease these impairments A recent systematic review confirms that unimanual and bimanual trainings effectively improve upper limb function in children with hemiparesis However it is still challenging to find the best individual training method for children with hemiparesis as there is much variability in treatment response
In the present study the effects and mechanisms of non-invasive electrostimulation of the hand called Sensory Afferent Electrostimulation SAES will be investigated SAES triggers action potentials in afferent nerve fibres leading to increased sensory afferent input in the sensorimotor regions of the brain Through this SAES can enhance excitability of the motor cortex and of upper limb performance While proven effective in adults after stroke SAES is safe with promising positive results in a very small study in children with hemiparesis However the investigation of efficacy of SAES on sensory and motor functions was so far neglected Modern stimulation and imaging methods revealed that whole-hand SAES induced increased strength of corticospinal projections and intracortical change measured with transcranial magnetic stimulation which may indicate long-term potentiation mechanisms Furthermore in a functional MRI study SAES induced increased motor cortex activity Hence resting state fMRI will allow to understand the efficacy of SAES on the topographically connectivity of the motor and sensorimotor network at rest
The experimental intervention consists of SAES with a glove or adhesive electrodes eg Cefar Reha X2 at 20Hz 300µs intensity between 2-10mA during 30 minutes per day 5xweek for 5 weeks combined with conventional occupation therapy The subsequent therapy sessions will take place at home with in-between telephone checks
The control intervention treatment as usual TAU consists of the prescribed conventional occupational therapy andor physiotherapy The evaluation of the UL sensory and motor function will be conducted at the University Childrens Hospital in Bern by blind assessors expert in the clinical measures and will take place before and after each intervention period and at 12-weeks follow-up
In the present study the effects and mechanisms of non-invasive electrostimulation of the hand called Sensory Afferent Electrostimulation SAES will be investigated SAES triggers action potentials in afferent nerve fibres leading to increased sensory afferent input in the sensorimotor regions of the brain Through this SAES can enhance excitability of the motor cortex and of upper limb performance While proven effective in adults after stroke SAES is safe with promising positive results in a very small study in children with hemiparesis However the investigation of efficacy of SAES on sensory and motor functions was so far neglected Modern stimulation and imaging methods revealed that whole-hand SAES induced increased strength of corticospinal projections and intracortical change measured with transcranial magnetic stimulation which may indicate long-term potentiation mechanisms Furthermore in a functional MRI study SAES induced increased motor cortex activity Hence resting state fMRI will allow to understand the efficacy of SAES on the topographically connectivity of the motor and sensorimotor network at rest
The experimental intervention consists of SAES with a glove or adhesive electrodes eg Cefar Reha X2 at 20Hz 300µs intensity between 2-10mA during 30 minutes per day 5xweek for 5 weeks combined with conventional occupation therapy The subsequent therapy sessions will take place at home with in-between telephone checks
The control intervention treatment as usual TAU consists of the prescribed conventional occupational therapy andor physiotherapy The evaluation of the UL sensory and motor function will be conducted at the University Childrens Hospital in Bern by blind assessors expert in the clinical measures and will take place before and after each intervention period and at 12-weeks follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None