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Withdrawn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
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
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
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
NCT ID
NCT04239274
First Posted
January 14, 2020
Last Updated
December 13, 2021
Sponsor
Medical University of South Carolina
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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