Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599931
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Cerebello-motor Neuromodulation After Stroke CERSTIM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CEREBELLO-MOTOR NEUROMODULATION AFTER STROKE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
CERSTIM
Brief Summary:
The CERSTIM study is a physiopatholgical study investigating transcranial alternating current stimulation in stroke patients in the cerebello-motor loop
The design is a cross over design testing two frequencies in the gamma band and one placebo
We will use behavioural data functional MRI and Electroencephalography to disentangle the effect of tACS and its frequency
Healthy participants will be also recruited
The design is a cross over design testing two frequencies in the gamma band and one placebo
We will use behavioural data functional MRI and Electroencephalography to disentangle the effect of tACS and its frequency
Healthy participants will be also recruited
Detailed Description:
Neuromodulation by the means of Non-Invasive Brain Stimulation techniques is a promising method to enhance motor recovery of the upper limb following a stroke However none of these techniques have yet been effectively transferred to the patients bedside An international group of experts has examined this issue identifying barriers that need to be overcome for successful transferability Among their findings two were particularly emphasized i the insufficient characterization of the mechanisms through which these stimulations are effective and ii the comparison of stimulation parameters before moving on to larger samples We have decided to use this model to study tACS transcranial Alternating Current Stimulation on the cerebellomotor network
The choice of tACS is justified by i its ability to entrain a neural network through its oscillations ii its innovative nature and iii its wearable characteristic making it quickly transferable The choice of the cerebellomotor network is based on literature data showing that i the cerebellum plays a crucial role in motor learning in healthy individuals which is one of the substrates of post-stroke recovery and ii cerebellomotor synchronization is a good prognostic indicator for the recovery of hand motor function
In light of these findings we have decided to conduct a pathophysiological bi-centric study to determine the cerebral mechanisms by which tACS acts on the cerebellomotor network Three single sessions of tACS each lasting 20 minutes will be conducted 7-15 days apart with a different frequency 50 or 70 Hz corresponding to gamma oscillations or a placebo frequency known as sham To understand the cerebral mechanisms we will use Magnetic Resonance Imaging MRI and Electroencephalography EEG We will also examine a behavioral motor adaptation task on a tablet The order in which the three frequencies are applied will be randomized This study will include 30 patients and 15 healthy subjects The patients will be individuals who have suffered a stroke more than 6 months ago resulting in a hand deficit without complete paralysis The healthy controls will serve as a reference for mechanisms and imagingelectrophysiology data
We hypothesize the following The mechanisms involved following cerebellomotor stimulation could include a modification of brain rhythms in the beta or gamma band during movement an increase in activity in the primary motor cortex or a change in the excitation-inhibition balance between the cerebellum and the primary motor cortex or directly at the level of the primary motor cortex These different mechanisms may vary depending on the frequency used
This research is part of the NEUROTECH Impulse Program managed by INSERM
The choice of tACS is justified by i its ability to entrain a neural network through its oscillations ii its innovative nature and iii its wearable characteristic making it quickly transferable The choice of the cerebellomotor network is based on literature data showing that i the cerebellum plays a crucial role in motor learning in healthy individuals which is one of the substrates of post-stroke recovery and ii cerebellomotor synchronization is a good prognostic indicator for the recovery of hand motor function
In light of these findings we have decided to conduct a pathophysiological bi-centric study to determine the cerebral mechanisms by which tACS acts on the cerebellomotor network Three single sessions of tACS each lasting 20 minutes will be conducted 7-15 days apart with a different frequency 50 or 70 Hz corresponding to gamma oscillations or a placebo frequency known as sham To understand the cerebral mechanisms we will use Magnetic Resonance Imaging MRI and Electroencephalography EEG We will also examine a behavioral motor adaptation task on a tablet The order in which the three frequencies are applied will be randomized This study will include 30 patients and 15 healthy subjects The patients will be individuals who have suffered a stroke more than 6 months ago resulting in a hand deficit without complete paralysis The healthy controls will serve as a reference for mechanisms and imagingelectrophysiology data
We hypothesize the following The mechanisms involved following cerebellomotor stimulation could include a modification of brain rhythms in the beta or gamma band during movement an increase in activity in the primary motor cortex or a change in the excitation-inhibition balance between the cerebellum and the primary motor cortex or directly at the level of the primary motor cortex These different mechanisms may vary depending on the frequency used
This research is part of the NEUROTECH Impulse Program managed by INSERM
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