Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01681589|
Recruitment Status : Recruiting
First Posted : September 10, 2012
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Device: Transcranial Direct Current Stimulator (TDCS) Device: Control Group Other: Healthy Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Relationship Between Attention and Emotional Regulation Post-TBI: Probing Neural Circuitry With Transcranial Direct Current Stimulation|
|Actual Study Start Date :||August 2012|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681589
|Contact: Preeti Raghavan, MDfirstname.lastname@example.org|
|Contact: Olanta Chandler, MSemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Zena Moore, MS 212-263-0344 email@example.com|
|Principal Investigator: Preeti Raghavan, MD|
|Principal Investigator:||Preeti Raghavan, MD||New York University School of Medicine|