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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01681589
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Actual Duration (Months): 82
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Device: Transcranial Direct Current Stimulator (TDCS); Device: Control Group; Other: Healthy Control Group	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Relationship Between Attention and Emotional Regulation Post-TBI: Probing Neural Circuitry With Transcranial Direct Current Stimulation
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: 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).	Device: Control Group; This group will receive Sham TDCS
Experimental: 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.	Device: Transcranial Direct Current Stimulator (TDCS); Group will receive active TDCS; Other Names: Fisher Wallace Cranial Stimulator The Fisher Wallace Stimulator, Model FW-100 FDA 510 (K)Cleared number K903654
Other: Healthy Control Group Fifteen (15) healthy control subjects will participate.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Prin Amorapanth, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol - May 6, 2019

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01681589
• Other Study ID Numbers: 11-00685
• First Posted: Sep 10, 2012
• Last Update Posted: Aug 21, 2020
• Last Verified: Aug 1, 2020

• 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
• Keywords provided by NYU Langone Health: TBI; Traumatic Brain Injury; Rehabilitation; Therapy
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic

Study Results

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.

Arm/Group Title	Control Group	Transcranial Direct Current Stimulator (TDCS)	Healthy Control Group
Arm/Group 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). Control Group: This group will receive Sham 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	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.
Period Title: Overall Study
STARTED	0	0	0
COMPLETED	0	0	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Transcranial Direct Current Stimulator (TDCS)	Healthy Control Group	Total
Arm/Group 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). Control Group: This group will receive Sham 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	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.	Total of all reporting groups
Overall Participants	0	0	0	0
Age () []
Sex: Female, Male () []
Female
Male
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control Group	Transcranial Direct Current Stimulator (TDCS)	Healthy Control Group
Arm/Group 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). Control Group: This group will receive Sham 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	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.
Measure Participants	0	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control Group	Transcranial Direct Current Stimulator (TDCS)	Healthy Control Group
Arm/Group 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). Control Group: This group will receive Sham 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	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.
Measure Participants	0	0	0

Adverse Events

Time Frame	7 years
Adverse Event Reporting Description	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.
Arm/Group Title	Control Group		Transcranial Direct Current Stimulator (TDCS)		Healthy Control Group
Arm/Group 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). Control Group: This group will receive Sham 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		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.
All Cause Mortality
	Control Group		Transcranial Direct Current Stimulator (TDCS)		Healthy Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Control Group		Transcranial Direct Current Stimulator (TDCS)		Healthy Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Control Group		Transcranial Direct Current Stimulator (TDCS)		Healthy Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.