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Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial direct current stimulation
transcranial pulsed current stimulation
Sham-no stimulation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Transcranial Direct Current Stimulation (tDCS)

    Transcranial Pulsed Stimulation tPCS

    No Stimulation

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2020
    Last Updated
    December 13, 2021
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04239274
    Brief Title
    Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no participants enrolled due to COVID
    Study Start Date
    January 1, 2020 (Actual)
    Primary Completion Date
    January 1, 2021 (Actual)
    Study Completion Date
    January 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Transcranial Direct Current Stimulation (tDCS)
    Arm Type
    Experimental
    Arm Title
    Transcranial Pulsed Stimulation tPCS
    Arm Type
    Experimental
    Arm Title
    No Stimulation
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    transcranial direct current stimulation
    Intervention Description
    Subjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps.
    Intervention Type
    Device
    Intervention Name(s)
    transcranial pulsed current stimulation
    Intervention Description
    Subjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps.
    Intervention Type
    Device
    Intervention Name(s)
    Sham-no stimulation
    Intervention Description
    Subjects in this arm will receive one session of sham for 20 minutes.
    Primary Outcome Measure Information:
    Title
    Average Reaction Time During Stop Signal Task
    Description
    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.
    Time Frame
    Throughout study (1 hour)
    Title
    EEG power in all frequency bands
    Description
    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.
    Time Frame
    Baseline and immediately post Stimulation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nathan Rowland, MD,PhD
    Organizational Affiliation
    Medical University of South Carolina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.

    Learn more about this trial

    Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

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