Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04239274
• Other study ID #: 00093356
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: December 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Impulsive Behavior
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• transcranial direct current stimulation
Subjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps.
• transcranial pulsed current stimulation
Subjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps.
• Sham-no stimulation
Subjects in this arm will receive one session of sham for 20 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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