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

NCT01681589 | Completed Results FDA Device

• 1 other identifier: 11-00685
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

TBI; Traumatic Brain Injury; Rehabilitation; Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Post Treatment Measures to Check Improvements

  Week 8

Study Arms (3)

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).

Device: Control Group

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.

Device: Transcranial Direct Current Stimulator (TDCS)

Healthy Control Group

OTHER

Fifteen (15) healthy control subjects will participate.

Other: Healthy Control Group

Interventions

Transcranial Direct Current Stimulator (TDCS) DEVICE

Group will receive active TDCS

Also known as: Fisher Wallace Cranial Stimulator, The Fisher Wallace Stimulator, Model FW-100, FDA 510 (K)Cleared number K903654

Transcranial Direct Current Stimulator (TDCS)

Control Group DEVICE

This group will receive Sham TDCS

Control Group

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.

Healthy Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Prin Amorapanth, MD, PhD
• Organization: NYU Langone Health

Prin.Amoropanth@nyulangone.org

212-263-6037

Study Officials

• Prin Amorapanth, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: September 10, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 21, 2020
• Results First Posted: August 21, 2020

Record last verified: 2020-08

Locations

US (1)