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Completed

NCT Number: NCT01681589

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulator (TDCS)

Device

Group will receive active TDCS

Other names: Fisher Wallace Cranial Stimulator, The Fisher Wallace Stimulator, Model FW-100, FDA 510 (K)Cleared number K903654

Control group

Device

This group will receive Sham TDCS

Healthy Control Group

Other

Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.

Primary outcomes

  1. Baseline Measures Before Treatment

    Time frame: Week 1

    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 outcomes

  1. Post Treatment Measures to Check Improvements

    Time frame: Week 8

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2012
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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