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

This study is currently recruiting participants.
Verified October 2013 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: October 30, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to understand the relationship between attention and emotional function after brain injury in an effort to develop better treatments for emotional problems as a result of brain injury.


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 2015
Estimated Primary Completion Date: December 2014 (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:

Previous studies have shown that emotional problems such as difficulty with emotional adjustment and relationships, lack of attention to people, unawareness of one's own or other peoples' feelings, lead to depression and anxiety and have a large impact on quality of life after brain injury. This study is to better understand how the brain works to control ones emotions after a brain injury. The investigators will also study a treatment method to improve control of ones emotions called Transcranial Direct Current Stimulation (tDCS). This method involves electrical stimulation of the scalp with sponge-soaked metal plates and a battery. This non-invasive treatment has already been cleared by the FDA for the treatment of anxiety, depression and insomnia which are problems patients are experiencing since their brain injury. Several studies have found this treatment useful for improving mental and physical functions after brain injury. The purpose of using this treatment is to understand how it affects changes in emotional functions.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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
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, BA 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, BA    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

No publications provided

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: October 30, 2013
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:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014