Traumatic Brain Injury
Conditions
Keywords
TBI, Traumatic Brain Injury, Rehabilitation, Therapy
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.
Interventions
Group will receive active TDCS
DEVICEControl Group
This group will receive Sham TDCS
Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Measures Before Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Post Treatment Measures to Check Improvements | 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. |
Countries
United States
Participant flow
Recruitment details
The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.
Participants by arm
| Arm | Count |
|---|---|
| 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).
Control Group: This group will receive Sham TDCS | 0 |
| 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.
Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS | 0 |
| Healthy Control Group Fifteen (15) healthy control subjects will participate.
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. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Week 1
Population: The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.
Secondary
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.
Time frame: Week 8
Population: The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.