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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulator (TDCS)
* Device: Control Group
* Other: Healthy Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Group<br>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<br>* This group will receive Sham TDCS<br>|
| Experimental: Transcranial Direct Current Stimulator (TDCS)<br>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)<br>* Group will receive active TDCS<br>* Other names: FDA 510 (K)Cleared number K903654;|
| Other: Healthy Control Group<br>Fifteen (15) healthy control subjects will participate. | Other: Healthy Control Group<br>* Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Traumatic Brain Injury, Rehabilitation, Therapy