Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

NCT ID: NCT04239274

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-01-01

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.

Conditions

Traumatic Brain Injury

Study Design

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

Study Groups

Transcranial Direct Current Stimulation (tDCS)

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

Subjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps.

Transcranial Pulsed Stimulation tPCS

Group Type: EXPERIMENTAL

transcranial pulsed current stimulation

Intervention Type: DEVICE

Subjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps.

No Stimulation

Group Type: SHAM_COMPARATOR

Sham-no stimulation

Intervention Type: DEVICE

Subjects in this arm will receive one session of sham for 20 minutes.

Interventions

transcranial direct current stimulation

Subjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps.

Intervention Type: DEVICE

transcranial pulsed current stimulation

Subjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps.

Intervention Type: DEVICE

Sham-no stimulation

Subjects in this arm will receive one session of sham for 20 minutes.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Nathan Rowland

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathan Rowland, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Other Identifiers

00093356

Identifier Type: -

Identifier Source: org_study_id