Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

NCT04239274 | Withdrawn

• 1 other identifier: 00093356
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Transcranial Direct Current Stimulation (tDCS)

EXPERIMENTAL

Device: transcranial direct current stimulation

Transcranial Pulsed Stimulation tPCS

EXPERIMENTAL

Device: transcranial pulsed current stimulation

No Stimulation

SHAM COMPARATOR

Device: Sham-no stimulation

Interventions

transcranial direct current stimulation DEVICE

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

Transcranial Direct Current Stimulation (tDCS)

transcranial pulsed current stimulation DEVICE

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

Transcranial Pulsed Stimulation tPCS

Sham-no stimulation DEVICE

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

No Stimulation

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Transcranial Direct Current Stimulation

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)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Nathan Rowland, MD,PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: For analyses to achieve aims in the approved proposal accessible by contacting the study principal investigator.