Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752800
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2021-02-10
Brief Title:
Brain Connectivity as a Biomarker of Response to Transcranial Stimulation by Continuous Current in Patients With Stroke
Sponsor:
Federal University of Paraíba
Organization:
Federal University of Paraíba
Study Overview
Official Title:
Brain Connectivity as a Biomarker of Response to Transcranial Stimulation by Continuous Current in Patients With Stroke Sham Controlled Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
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:
A randomized double-blind sham-controlled clinical trial will be conducted with 30 people with stroke recruited at a referral hospital in João Pessoa After recruitment they will be randomized into two groups Group 1 - active stimulation and group - 2 sham stimulation Participants will receive 10 sessions of ETCC for 20 minutes on alternate days 3 times a week where the electrodes will be positioned over the primary motor cortex 3 minutes of EEG at rest will be taken from each participant and they will be instructed not to be actively involved in any cognitive or mental activity In the first and last meetings evaluations will be carried out the outcomes evaluated will be motor function quality of life and functional connectivity
Detailed Description:
Previous studies analyzed by systematic reviews suggest that the effects of ETCC may vary between subjects where some stroke patients may not receive any additional benefits from therapy Thus it is necessary to use a biomarker that manages to elect those who will possibly benefit from the electric current Therefore the objective of this study is to investigate whether the EEG measures of functional connectivity of the target network of the stimulation are associated with the response to ipsilesional anodic ETCC in patients with stroke in the late subacute phase as well as to observe if these findings can be associated with a clinical improvement of the patient For that a randomized double-blind sham-controlled clinical trial will be carried out with 30 people with stroke recruited at a referral hospital in joão Pessoa
After recruitment they will be randomized into two groups Group 1 - active stimulation and group - 2 sham stimulation Participants will receive 10 sessions of ETCC for 20 minutes on alternate days 3 times a week where the electrodes will be positioned over the primary motor cortex 3 minutes of EEG at rest will be taken from each participant Eyes open and eyes closed and they will be instructed not to be actively involved in any cognitive or mental activity In the first and last meetings evaluations will be carried out the outcomes assessed will be motor function quality of life and functional connectivity
After recruitment they will be randomized into two groups Group 1 - active stimulation and group - 2 sham stimulation Participants will receive 10 sessions of ETCC for 20 minutes on alternate days 3 times a week where the electrodes will be positioned over the primary motor cortex 3 minutes of EEG at rest will be taken from each participant Eyes open and eyes closed and they will be instructed not to be actively involved in any cognitive or mental activity In the first and last meetings evaluations will be carried out the outcomes assessed will be motor function quality of life and functional connectivity
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