Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

Not Applicable

Withdrawn

• Conditions: Traumatic Brain Injury
• Interventions: Device: transcranial direct current stimulation; Device: transcranial pulsed current stimulation; Device: Sham-no stimulation

• Registration Number: NCT04239274
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-27
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial Direct Current Stimulation (tDCS)	transcranial direct current stimulation	-
Transcranial Pulsed Stimulation tPCS	transcranial pulsed current stimulation	-
No Stimulation	Sham-no stimulation	-

Primary Outcome Measures

Name	Time	Method
Average Reaction Time During Stop Signal Task	Throughout study (1 hour)	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.
EEG power in all frequency bands	Baseline and immediately post Stimulation	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.