MRI Markers of Feedback Timing During Learning in Individuals with TBI with and Without Clinical Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this proposal is to examine the influence of feedback timing on learning and brain function in individuals with moderate-to-severe traumatic brain injury (TBI), with and without depression.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback

NCT06050070

Major Depressive Disorder

RECRUITING NA

Frontoparietal Priority Maps as Biomarkers for MTBI

NCT02251002

TBI (Traumatic Brain Injury) Ocular Motility Disorders

COMPLETED

Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients

NCT00580918

Mild Traumatic Brain Injury

WITHDRAWN

Change in Connectivity After mTBI Depending on Cognitive Reserve

NCT05593172

Mild Traumatic Brain Injury

COMPLETED

Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury

NCT01132937

Traumatic Brain Injury

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The overall objective of the proposed project is to investigate brain mechanisms during learning in individuals with traumatic brain injury (TBI) with and without clinical depression. Such knowledge can help guide rehabilitation strategies and reduce the burden of TBI. Feedback about the accuracy of one's actions can improve learning by informing an individual whether his/her action is correct or not. Individuals with depression have been shown to have learning deficits and altered brain activity during learning compared to healthy individuals when feedback is presented immediately. Impaired learning through immediate feedback has also been observed in Parkinson's disease (PD) patients. However, PD patients are able to learn from feedback when it is presented after a delay, engaging separate neural mechanisms. Individuals with TBI have also been shown to have learning deficits that are likely exacerbated by depressive symptoms. However, there is no evidence directly examining the neural mechanisms of learning in individuals with TBI with and without depression. The proposed research explores this distinction.

The elucidation of the neural mechanisms associated with learning in individuals with TBI with and without clinical depression will inform 1) scientific knowledge about the effect of depression on the injured brain, 2) TBI interventions about the effectiveness of feedback and its timing, and 3) interventions for other clinical populations that require rehabilitation and have high occurrence of depression. These objectives lie at the heart of the mission of the National Institute of Neurological Disorders and Stroke as they will broaden "fundamental knowledge about the brain and nervous system" associated with learning in TBI and the knowledge gained from fulfilling the above objectives will "reduce the burden" of learning deficits after TBI.

To test these hypotheses, participants will be recruited based on structured clinical interview performed by the team member trained in psychiatric interviewing. Qualified participants will perform an experiment during which they will first study word pairs outside of the functional magnetic resonance imaging scanner. Then, in the scanner, participants will see word pairs again in a multiple-choice format and will have to choose a match for each word. After participants make their choice, feedback will be presented either immediately or after a delay of 25 minutes. The experiment will end with the Test phase, which takes place outside of the scanner, where participants will be presented with the words in the multiple-choice format again so the influence of each feedback type on learning can be evaluated.

Investigators hypothesize that depressed individuals with and without TBI will learn better from delayed compared to immediate feedback, because learning through delayed feedback relies on a different neural mechanism, which is not affected by depression and TBI, compared to learning through immediate feedback. Non-depressed individuals without TBI and clinically depressed individuals without TBI will also be recruited to delineate the influences of depression from the impact of TBI on the brain.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Traumatic Brain Injury (TBI)

Individuals with moderate-to-severe injury severity, defined as post-traumatic amnesia lasting more than 24hrs, loss of consciousness lasting more than 30 min, Glasgow Coma Scale (GCS) score less than 13.

Group Type EXPERIMENTAL