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tDCS and Inhibitory Control in PTSD

Primary Purpose

Post Traumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tDCS
Sponsored by
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post Traumatic Stress Disorder focused on measuring noninvasive brain stimulation, inhibitory control, transcranial direct current stimulation

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Ability to provide informed consent Ability and willingness to perform procedures Age 18-55 Female sex Meet diagnostic criteria for past-month probable IPV-related PTSD. Medication free or stable (≥4 weeks) medication(s) Exclusion Criteria: Unstable medical, psychiatric, or neurological condition that may necessitate urgent treatment Contraindications for tDCS History of psychosis, mania, major neurological disorder, significant head trauma, or epilepsy. Daily use of psychostimulant medication Daily use of medications that significantly lower seizure threshold Current suicidal intent History of seizures Current pregnancy Moderate severity substance-use disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Active tDCS

    Shame tDCS

    Arm Description

    Current will be ramped in/out for 15 seconds at the beginning and end of a 15-minute period and a constant current will be delivered for the 15-minutes between ramping

    Current will be ramped in/out for 15 seconds at the beginning and end of a 15-minute period during which no stimulation will be delivered.

    Outcomes

    Primary Outcome Measures

    Stop Signal Reaction Time (SSRT)
    SSRT is a measure of inhibitory control that is calculated by subtracting the mean stop signal delay on "stop" trials from the mean response time on "go" trials
    Skin conductance level (SCL)
    SCL will be measured by collecting electrodermal activity (EDA) on the left hand. Mean SCL during trauma related images will be utilized as a measure of emotional reactivity to trauma-related images.
    Heart Rate (HR)
    HR will be measured using a photophylesmograph on the left hand. Mean HR during trauma related images will be utilized as a measure of emotional reactivity to trauma-related images.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2023
    Last Updated
    October 19, 2023
    Sponsor
    University of Kentucky
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06100731
    Brief Title
    tDCS and Inhibitory Control in PTSD
    Official Title
    Evaluating the Impact of Transcranial Direct Current Stimulation on Inhibitory Control in PTSD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 18, 2024 (Anticipated)
    Study Completion Date
    December 18, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Kentucky

    4. Oversight

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

    5. Study Description

    Brief Summary
    Large samples (~2,000/yr) of adult undergraduate students at a large southern university will be pre-screened via the University of Kentucky SONA System (IRB#43626) to identify and recruit adult female participants who report a history of IPV and probable PTSD to participate in a one-day lab study. After completing an IRB-approved informed consent, participants will complete a brief psychiatric diagnostic interview and a battery of questionnaires. They will then complete three blocks of the Stop Signal Task (SST). Participants will be randomized (double-blind, stratified by PTSD diagnosis and psychotropic medication use) to receive 15-min of active or sham multifocal tDCS targeting the rIFG. tDCS will be delivered offline for 11.5-mins after block 1 of the SST and online for 3.5-mins during block 2 of the SST. Sham stimulation will be identical to active tDCS, but electrical current will only be ramped in/out at the beginning and end of the 15-mins. The third block of the SST will be completed after tDCS. Lastly, participants will complete a pictorial trauma-related symptom provocation task. Participants will be compensated with course credit.
    Detailed Description
    Inhibitory control deficits may be a hallmark neuropsychological feature of posttraumatic stress disorder (PTSD). Right inferior frontal gyrus (rIFG) activation is associated with stop signal reaction time (SSRT) - a common measure of inhibitory control - in healthy controls and PTSD patients. PTSD patients exhibit hypoactivation of the rIFG during inhibitory control tasks compared to healthy controls. Moreover, individuals with PTSD may exhibit difficulty modulating rIFG activity in response to increased inhibitory control demands. The rIFG is also implicated in emotional expression and inhibition. For example, rIFG lesions are associated with difficulty modulating emotional responses and several imaging studies have found that rIFG activity is positively associated with conscious inhibition of negative affect. Among individuals with PTSD, rIFG activity is negatively associated with the severity of PTSD symptoms and the severity of re-experiencing and dissociative symptoms during symptom provocation tasks. A recent meta-analysis indicates that a single-session of bipolar, anodal (excitatory) neuromodulation of the rIFG with transcranial direct current stimulation (tDCS) can significantly improve SSRT performance (g=0.32). Additionally, multiple studies suggest that anodal tDCS of the rIFG reduce fearful responding to threatening stimuli among psychiatrically healthy participants. One study has examined the effects of tDCS targeting the rIFG on inhibitory control and psychiatric symptoms among a clinical sample that included PTSD patients. Although tDCS did not significantly impact inhibitory control in this study, the use of a mixed psychiatric sample and imprecise tDCS procedures make interpretations difficult. Research has yet to test the effects of tDCS targeting the rIFG on inhibitory control or emotional reactivity in individuals with PTSD. The proposed study would be the first to explore the effects of multifocal tDCS on inhibitory control and emotional reactivity to trauma cues in a sample of individuals with probable PTSD. This study would contribute to a growing body of evidence showing that tDCS can improve cognitive functioning and influence the expression and inhibition of emotions. Findings may support future research exploring rIFG neuromodulation as an adjunctive treatment for PTSD or a preventative intervention following trauma exposure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Traumatic Stress Disorder
    Keywords
    noninvasive brain stimulation, inhibitory control, transcranial direct current stimulation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects will be randomly assigned to receive Active (real) or Sham (placebo) transcranial direct current stimulation.
    Masking
    ParticipantInvestigator
    Masking Description
    Randomization (stratified by PTSD status and medication use) into active or shame tDCS. Double blind software will be used to ensure that the experimenter and the subject remain blind during task administration.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active tDCS
    Arm Type
    Active Comparator
    Arm Description
    Current will be ramped in/out for 15 seconds at the beginning and end of a 15-minute period and a constant current will be delivered for the 15-minutes between ramping
    Arm Title
    Shame tDCS
    Arm Type
    Sham Comparator
    Arm Description
    Current will be ramped in/out for 15 seconds at the beginning and end of a 15-minute period during which no stimulation will be delivered.
    Intervention Type
    Device
    Intervention Name(s)
    tDCS
    Other Intervention Name(s)
    Starstim®, transcranial direct current stimulation, transcranial electrical stimulation
    Intervention Description
    Subjects will receive 20 minutes of multifocal transcranial direct current stimulation. The anode will be placed over the frontal pole (FC6, 10-10 EEG) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in/ out at the beginning and end of the 15-minutes of stimulation over the course of 15 seconds.
    Primary Outcome Measure Information:
    Title
    Stop Signal Reaction Time (SSRT)
    Description
    SSRT is a measure of inhibitory control that is calculated by subtracting the mean stop signal delay on "stop" trials from the mean response time on "go" trials
    Time Frame
    Day 1
    Title
    Skin conductance level (SCL)
    Description
    SCL will be measured by collecting electrodermal activity (EDA) on the left hand. Mean SCL during trauma related images will be utilized as a measure of emotional reactivity to trauma-related images.
    Time Frame
    Day 1
    Title
    Heart Rate (HR)
    Description
    HR will be measured using a photophylesmograph on the left hand. Mean HR during trauma related images will be utilized as a measure of emotional reactivity to trauma-related images.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to provide informed consent Ability and willingness to perform procedures Age 18-55 Female sex Meet diagnostic criteria for past-month probable IPV-related PTSD. Medication free or stable (≥4 weeks) medication(s) Exclusion Criteria: Unstable medical, psychiatric, or neurological condition that may necessitate urgent treatment Contraindications for tDCS History of psychosis, mania, major neurological disorder, significant head trauma, or epilepsy. Daily use of psychostimulant medication Daily use of medications that significantly lower seizure threshold Current suicidal intent History of seizures Current pregnancy Moderate severity substance-use disorder
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thomas Adams, PhD
    Phone
    859-257-6841
    Email
    tgad224@uky.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Colton S Rippey, MS
    Phone
    623-695-8327
    Email
    csri227@uky.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Upon data de-identification, data will be available upon request after study publication. Upon request, other supporting documents (e.g., study protocol and analytic code) will also be available
    IPD Sharing Time Frame
    May 2025 for 9 years.
    IPD Sharing Access Criteria
    Must be a doctoral-level researcher. Must request documents from the PI or Co-I of the study.

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