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NCT04099524 · ClinicalTrials.gov registry record · NA

CogT BEEM Study (a tDCS Study)

A NA study, sponsored by University of Rochester.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT04099524 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 40 participants.

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The verdict

NCT04099524, a NA study, has completed, sponsored by University of Rochester.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study 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 Alzheimer's 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 \[i.e. left precentral gyrus (LPG), critical for regulating visual attention\] 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 infor

Interventions

  • DEVICE tDCS

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-12-06
Est. Completion 2022-01-19
Phase NA

Sponsor

University of Rochester

636 total trials

What the Registry Record Tells You About NCT04099524

The ClinicalTrials.gov registry entry for NCT04099524 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which tDCS is the first listed.

NCT04099524 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04099524 about?

NCT04099524 is a clinical study titled "CogT BEEM Study (a tDCS Study)". 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 Alzheimer's disease (AD). Optimal NPS management, meaning effectively managing mul...

What is the current status of trial NCT04099524?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-12-06. Estimated completion is 2022-01-19.

What interventions are being tested in trial NCT04099524?

The interventions under investigation include: tDCS (DEVICE).

Who is sponsoring clinical trial NCT04099524?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.