Ignite Creation Date:
2024-05-06 @ 1:41 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04099524
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2019-09-19
Brief Title:
CogT BEEM Study a tDCS Study
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Effectiveness of a Non-Invasive Low-Intensity Brain Stimulation Approach in Addressing Emotional Regulation
Status:
COMPLETED
Status Verified Date:
2023-11
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:
Co-existing neuropsychiatric symptoms NPS in patients with mild cognitive impairment MCI especially those worsening over time are associated with more rapid cognitive and functional decline and a greater risk of Alzheimers disease AD Optimal NPS management meaning effectively managing multiple NPS simultaneously requires a solid understanding of the shared neural mechanism across NPS The goal of this proof-of-concept mechanistic intervention study is to validate the causal relationship between a NPS-shared neural circuit the investigators previously discovered and various NPS The investigators will modify a key region within the NPS-shared neural circuit ie left precentral gyrus LPG critical for regulating visual attention with anodal transcranial direct current stimulation tDCS Our central hypothesis is that an activation of LPG and a reorganization of NPS-shared neural circuit will link to improvement in multiple NPS Using a Stage 0 pilot randomized control trial design the investigators will recruit n 40 older adults with informant-rated NPS that has worsened in the past 2 years which is considered the most detrimental type of NPS in MCI The investigators will assign participants to 4-week active anodal vs sham LPG online tDCS group The investigators will assess resting-state and visual attention task-related functional MRI and informant-rated NPS at baseline and the end of week 4 and week 8 and diffusion MRI at baseline The two primary aims are to determine the effect of tDCS on NPS-shared neural circuit Aim 1 as well as the relationship between NPS-shared neural circuit and informant-report NPS Aim 2 The exploratory aim will be to examine the relationship between NPS and the coherence between structural and functional aspects of the NPS-shared neural circuit Probing the LPG via anodal tDCS provides a way to experimentally test the causal relationship between our previously discovered NPS-shared neural circuit and informant-rated NPS The proposed research is highly innovative while scientifically grounded for targeting one brain region that may affect multiple NPS Validating the hypotheses has the potential for future R01 study that directly conducts a Stage 2 trial addressing NPS in MCI and thus ultimately improves patients quality of life and reducing caregiving burden
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21MH120734 | NIH | None | httpsreporternihgovquickSearchR21MH120734 |