Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury: A Study of the Effect of Transcranial Electrical Stimulation of the Ventrolateral Prefrontal Cortex on Response Inhibition

Transcranial electrical stimulation (tES) is a non-invasive form of brain stimulation that has previously been to shown to have therapeutic potential in traumatic brain injury (TBI) patients. In this study, the study team will use a brain activity monitor (electroencephalogram, EEG) and a computer-based task to observe the effects of different forms of tES, like transcranial direct current stimulation (tDCS) and transcranial pulsed current stimulation (tPCS), on impulse control and sustained attention in people with TBI. Additionally, the study team will measure how much tDCS and tPCS affect the brain activity of a specific area of the brain associated with impulse control and attention. Problems with response inhibition have been shown to make rehabilitation more difficult for people with TBI. It also reduces social functioning and can also negatively affect job performance, which ultimately lead to a decreased quality of life. A better understanding of the effects of tES in TBI patients could be informative in finding out what its therapeutic potential is for this population.

Study Overview

• Status: Withdrawn
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: transcranial direct current stimulation; Device: transcranial pulsed current stimulation; Device: Sham-no stimulation

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects referred to the PI for management of TBI
• Subject is at least 3 months post-injury at the time of consent
• Ages 25-70

Exclusion Criteria:

• Subjects with the inability to consent for themselves
• Subjects with body habitus that does not allow the EEG cap to be properly placed
• Presence of scalp injury or disease
• Allergic reaction to topical lidocaine jelly
• Prior intracranial surgery or skull-fracture over VLPFC
• Presence of hemorrhage on intracranial imaging
• Prior brain radiotherapy
• Prior history of intracranial tumor, intracranial infection, or cerebrovascular malformation
• Subjects with the inability to see and read from a computer screen
• History of any form of seizures prior to TBI or within 6 months of study participation
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial Direct Current Stimulation (tDCS)	Device: transcranial direct current stimulation; Subjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps.
Experimental: Transcranial Pulsed Stimulation tPCS	Device: transcranial pulsed current stimulation; Subjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps.
Sham Comparator: No Stimulation	Device: Sham-no stimulation; Subjects in this arm will receive one session of sham for 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Reaction Time During Stop Signal Task	The Stop Signal Task (SST) is an assessment which requires participants to respond to various stimuli with a specific action and to not respond when a "stop" stimulus is presented.	Throughout study (1 hour)
EEG power in all frequency bands	They will be fitted with a standard EEG cap consisting of 32 EEG electrodes placed in the 10/20 international system format, a standardized system for EEG electrode placement. Frequency bands will be measured.	Baseline and immediately post Stimulation

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Nathan Rowland, MD,PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Impulsive Behavior
• Other Study ID Numbers: 00093356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification may be shared as well as the study protocol, statistical analysis plan, and analytic code.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: For analyses to achieve aims in the approved proposal accessible by contacting the study principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No