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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01681589
First received: August 16, 2012
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Traumatic Brain Injury
Device: Transcranial Direct Current Stimulator (TDCS)
Device: Control Group
Other: Healthy Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Relationship Between Attention and Emotional Regulation Post-TBI: Probing Neural Circuitry With Transcranial Direct Current Stimulation

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Baseline Measures before Treatment [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Post Treatment Measures to check improvements [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681589

Contacts
Contact: Preeti Raghavan, MD 212-263-0344 preeti.raghavan@nyumc.org
Contact: Zena Moore, MS 212-263-0344 zena.moore@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Preeti Raghavan, MD    212-263-0344    preeti.raghavan@nyumc.org   
Contact: Zena Moore, MS    212-263-0344    zena.moore@nyumc.org   
Principal Investigator: Preeti Raghavan, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Preeti Raghavan, MD New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01681589     History of Changes
Other Study ID Numbers: 11-00685 
Study First Received: August 16, 2012
Last Updated: March 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
TBI
Traumatic Brain Injury
Rehabilitation
Therapy

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 25, 2016