Clinical Trials Logo

Clinical Trial Summary

The current project will examine the impact of an emotional processing intervention on emotional processing abilities in a sample of 50 persons with moderate to severe TBI. Outcome will be assessed across 3 domains. We will document changes resulting from treatment: (1) in emotional processing tasks (2) in other areas of function including QOL, social functioning, mood and cognition that are also likely to be impacted (3) in brain structure and function. The examination of efficacy in the above three areas will further our knowledge of emotional processing deficits in TBI and more importantly, identify an effective means of treating such deficits.


Clinical Trial Description

Emotional processing deficits have a significant negative impact on the lives of persons with TBI. There is emerging research indicating that, in addition to cognitive and behavioral impairments, social and emotional difficulties following TBI are common and are related to significant problems in social relationships, poor social participation, impaired empathy, and a high degree of caregiver stress. Emotional processing is a critical component of social cognition, including the abilities to both identify and discriminate basic universal emotions. The stability of emotional processing deficits following TBI indicates that these impairments likely impact individuals with TBI consistently across the lifespan, and do not appear to resolve with time.

The goals of the trial are to (a) Evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI, (b) Evaluate the improvement of secondary outcomes of psychological, cognitive, and functional abilities following the emotional processing intervention in individuals with TBI, (c) To examine differences in brain activation patterns during emotional processing following treatment in individuals with TBI, BOLD activation in the experimental group will be compared to BOLD patterns of the control group during performance of the QFDT, a facial affect recognition task. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03373331
Study type Interventional
Source Kessler Foundation
Contact Angela Smiith, MA
Phone 973-324-8448
Email asmith@kesslerfoundation.org
Status Recruiting
Phase N/A
Start date September 2015
Completion date May 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Recruiting NCT03698747 - Myelin Imaging in Concussed High School Football Players
Recruiting NCT02059941 - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines N/A
Recruiting NCT03307070 - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury N/A
Not yet recruiting NCT03559114 - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST) Phase 3
Not yet recruiting NCT03227354 - Validation of Non-invasive Absolute Intracranial Pressure Monitoring N/A
Recruiting NCT02962349 - TRansfusion Strategies in Acute Brain INjured Patients N/A
Active, not recruiting NCT02339220 - The Brave Initiative: Bringing Rehabilitation to American Veterans in an Enriched Environment N/A
Completed NCT02836951 - Rapid Diagnostics for Traumatic Brain Injury (TBI) N/A
Recruiting NCT02613936 - Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury N/A
Recruiting NCT02255799 - Multicenter Evaluation of Memory Remediation After TBI With Donepezil Phase 3
Recruiting NCT02465242 - Pupillometry for the Prediction of Neurologic Outcomes in Severe Traumatic Brain Injury N/A
Active, not recruiting NCT02424656 - Alterations in the Brain's Connectome After Severe Traumatic Brain Injury
Terminated NCT02148783 - Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI Phase 2
Terminated NCT02218216 - TBI MR Study 3 Houston Methodist N/A
Withdrawn NCT02148367 - Effect of Recombinant Erythropoietin on Numbers of Circulating Endothelial Progenitor Cells in Subacute TBI Phase 2
Active, not recruiting NCT01606111 - The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery Phase 4
Active, not recruiting NCT01874847 - PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin Phase 2/Phase 3
Active, not recruiting NCT01618786 - Flooring for Injury Prevention Trial N/A