Back to resultsRelationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulator (TDCS)
Control Group
Healthy Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring TBI, Traumatic Brain Injury, Rehabilitation, Therapy
Eligibility 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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Other
Arm Label
Control Group
Transcranial Direct Current Stimulator (TDCS)
Healthy Control Group
Arm Description
The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).
The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.
Fifteen (15) healthy control subjects will participate.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01681589
Brief Title
Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)
Official Title
Relationship Between Attention and Emotional Regulation Post-TBI: Probing Neural Circuitry With Transcranial Direct Current Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
TBI, Traumatic Brain Injury, Rehabilitation, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).
Arm Title
Transcranial Direct Current Stimulator (TDCS)
Arm Type
Experimental
Arm Description
The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.
Arm Title
Healthy Control Group
Arm Type
Other
Arm Description
Fifteen (15) healthy control subjects will participate.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulator (TDCS)
Other Intervention Name(s)
Fisher Wallace Cranial Stimulator, The Fisher Wallace Stimulator, Model FW-100, FDA 510 (K)Cleared number K903654
Intervention Description
Group will receive active TDCS
Intervention Type
Device
Intervention Name(s)
Control Group
Intervention Description
This group will receive Sham TDCS
Intervention Type
Other
Intervention Name(s)
Healthy Control Group
Intervention Description
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 Outcome Measure Information:
Title
Baseline Measures Before Treatment
Description
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.
Time Frame
Week 1
Secondary Outcome Measure Information:
Title
Post Treatment Measures to Check Improvements
Description
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.
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prin Amorapanth, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)
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