Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Sham Comparator | The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions). |
|
| Transcranial Direct Current Stimulator (TDCS) | Experimental | The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks. |
|
| Healthy Control Group | Other | Fifteen (15) healthy control subjects will participate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulator (TDCS) | Device | Group will receive active TDCS |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prin Amorapanth, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Transcranial Direct Current Stimulator (TDCS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Week 1 |
|
7 years
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prin Amorapanth, MD, PhD | NYU Langone Health | 212-263-6037 | Prin.Amoropanth@nyulangone.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2019 | Aug 5, 2020 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Week 8 |
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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
| OG001 | 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 |
| OG002 | 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. |
|
| 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. | 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. | Posted | Week 8 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D008722 | Methods |