Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)

Relationship Between Attention and Emotional Regulation Post-TBI: Probing Neural Circuitry With Transcranial Direct Current Stimulation

The purpose of this pilot study is to investigate the relationship between attention and emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the cognitive mechanisms of emotional processing in patients with TBI, and explore novel treatment strategies to improve emotional regulation using with transcranial direct current stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: Control Group; Device: Transcranial Direct Current Stimulator (TDCS); Other: Healthy Control Group

Detailed Description

Thirty (30) individuals status post TBI with complaints of emotional dysfunction 6 months post-brain injury and Fifteen (15) healthy controls will participate in the study. The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30-45 minutes for 6 weeks as described below. The control group will receive sham-tDCS 20 minutes and computerized cognitive training for 30-45 minutes twice a week for 6 weeks (12 training sessions). The sham group will not receive real tDCS after completion of the study.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Brain Injury at least 6 months prior
• Family or self-identification of cognitive or emotional difficulties
• Unchanged and stabilized medical treatment in the three weeks prior to the screening

Exclusion Criteria:

• Any social or medical problem that precludes completion of the protocol.
• Presence of focal motor deficits in the upper extremities.
• Comorbid psychiatric disease such as schizophrenia, or active substance abusers (except nicotine).
• History of craniectomy, active infection, or seizure activity beyond 1 week post-TBI.
• Complicating medical problems such as uncontrolled hypertension, diabetes with signs of neuropathy, and previous neurological illness such as head trauma, prior stroke, epilepsy or demyelinating disease, implanted neuromodulatory or electronic device, metal in head
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Control Group; The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).	Device: Control Group; This group will receive Sham TDCS
EXPERIMENTAL: Transcranial Direct Current Stimulator (TDCS); The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.	Device: Transcranial Direct Current Stimulator (TDCS); Group will receive active TDCS; Other Names: Fisher Wallace Cranial Stimulator; The Fisher Wallace Stimulator, Model FW-100; FDA 510 (K)Cleared number K903654
OTHER: Healthy Control Group; Fifteen (15) healthy control subjects will participate.	Other: Healthy Control Group; Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Measures Before Treatment	Patients meeting criteria to particpate in the study will be tested at baseline. During Visit 1, patients will be tested to measure how alert they are, their ability to perform actions one after the other and other mental functions. On Visit 2, patients will be tested on your ability to control your emotions. On Visit 3, patients will have a brain scan (MRI) to help the investigators understand how various parts of your brain are connected.	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Treatment Measures to Check Improvements	Testing will be done again at the end of 6 weeks. This will allow the investigators to determine if there have been improvements in the patients attention and emotional function. The same assessments will be repeated again as with Visits 1-3. Investigators will ask questions regarding patients emotional well-being. An MRI will once again be performed.	Week 8

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Prin Amorapanth, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2012
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: September 5, 2012
• First Posted (ESTIMATE): September 10, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; TBI; Therapy; Traumatic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 11-00685

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No