Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517706
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Brain Research and Integrative Neuroscience Network for COVID-19
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Brain Research and Integrative Neuroscience Network for COVID-19 BRAINN
Status:
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:
BRAINN
Brief Summary:
The aim of the experimental study is to investigate two interventions for the management of cognitive symptoms resulting from long COVID Participants will be randomly assigned into two interventions 1 Categorization Program CP training with active tDCS or 2 Categorization Program training with sham tDCS
Detailed Description:
The two intervention protocols digitalized CP and NIBS required for this study have been developed and the required equipment one existing and three new tDCS devices has been acquired Recruitment for the feasibility study is planned to begin in month 18 ie June 2024
Changes in the design of the feasibility study have been made by the SC and in coordination with the Advisory Board The changes were deemed necessary to improve the original study design to capture changes in cognition due to treatment Specifically the feasibility study will retain the two-group design experimental and control Forty participants with PCS will be recruited instead of seventy as originally planned All participants will undergo the diagnostic protocols the neuroimaging and neuropsychological assessments Then participants will be randomly assigned into two groups the experimental who will receive the active tDCS and CP intervention and the control group who will receive the sham tDCS and CP intervention Following the intervention all participants experimental and control will complete a series of dependent measures including neuropsychological performance and quality of life measures For neurophysiological measures electroencephalography EEG has been replaced with functional near-infrared spectroscopy fNIRS which will be conducted both pre- and post-intervention The current design will require a longer intervention period as compared to the original design and the complete delivery of the digitalized CP to maximize treatment effectiveness
Changes in the design of the feasibility study have been made by the SC and in coordination with the Advisory Board The changes were deemed necessary to improve the original study design to capture changes in cognition due to treatment Specifically the feasibility study will retain the two-group design experimental and control Forty participants with PCS will be recruited instead of seventy as originally planned All participants will undergo the diagnostic protocols the neuroimaging and neuropsychological assessments Then participants will be randomly assigned into two groups the experimental who will receive the active tDCS and CP intervention and the control group who will receive the sham tDCS and CP intervention Following the intervention all participants experimental and control will complete a series of dependent measures including neuropsychological performance and quality of life measures For neurophysiological measures electroencephalography EEG has been replaced with functional near-infrared spectroscopy fNIRS which will be conducted both pre- and post-intervention The current design will require a longer intervention period as compared to the original design and the complete delivery of the digitalized CP to maximize treatment effectiveness
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