Trial Outcomes & Findings for Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI) (NCT NCT01681589)
NCT ID: NCT01681589
Last Updated: 2020-08-21
Results Overview
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.
COMPLETED
NA
40 participants
Week 1
2020-08-21
Participant Flow
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.
Participant milestones
| Measure |
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
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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
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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.
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Week 1Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Control Group
Transcranial Direct Current Stimulator (TDCS)
Healthy Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place