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

NCT ID: NCT01681589

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2019-06-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: SHAM_COMPARATOR

Control Group

Intervention Type: DEVICE

This group will receive Sham TDCS

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.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulator (TDCS)

Intervention Type: DEVICE

Group will receive active TDCS

Healthy Control Group

Fifteen (15) healthy control subjects will participate.

Group Type: OTHER

Healthy Control Group

Intervention Type: 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.

Interventions

Transcranial Direct Current Stimulator (TDCS)

Group will receive active TDCS

Intervention Type: DEVICE

Control Group

This group will receive Sham TDCS

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Fisher Wallace Cranial Stimulator; The Fisher Wallace Stimulator, Model FW-100; FDA 510 (K)Cleared number K903654

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prin Amorapanth, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

11-00685

Identifier Type: -

Identifier Source: org_study_id