tDCS and Inhibitory Control in PTSD

NCT06100731 | Completed

• 1 other identifier: 88372
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

noninvasive brain stimulation; inhibitory control; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (3)

• 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

  Day 1

• 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.

  Day 1

• 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.

  Day 1

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

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

Device: tDCS

Shame tDCS

SHAM COMPARATOR

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.

Device: tDCS

Interventions

tDCS DEVICE

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.

Also known as: Starstim®, transcranial direct current stimulation, transcranial electrical stimulation

Active tDCS; Shame tDCS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gopalkumar Rakesh: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gopalkumar Rakesh, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects will be randomly assigned to receive Active (real) or Sham (placebo) transcranial direct current stimulation.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 25, 2023
• Study Start: October 27, 2023
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: May 2025 for 9 years.
• Access Criteria: * Must be a doctoral-level researcher. * Must request documents from the PI or Co-I of the study.

Locations

US (1)