tDCS and Inhibitory Control in PTSD

NCT ID: NCT06100731

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-27
• Study Completion Date: 2024-12-04

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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Active tDCS

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

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: 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.

Shame tDCS

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.

Group Type: SHAM_COMPARATOR

tDCS

Intervention Type: 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.

Interventions

tDCS

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.

Intervention Type: DEVICE

Other Intervention Names

Starstim®; transcranial direct current stimulation; transcranial electrical stimulation

Eligibility Criteria

Inclusion Criteria

1. Ability to provide informed consent

2. Ability and willingness to perform procedures

3. Age 18-55

4. Female sex

5. Meet diagnostic criteria for past-month probable IPV-related PTSD.

6. Medication free or stable (≥4 weeks) medication(s)

Exclusion Criteria

1. Unstable medical, psychiatric, or neurological condition that may necessitate urgent treatment

2. Contraindications for tDCS

3. History of psychosis, mania, major neurological disorder, significant head trauma, or epilepsy.

4. Daily use of psychostimulant medication

5. Daily use of medications that significantly lower seizure threshold

6. Current suicidal intent

7. History of seizures

8. Current pregnancy

9. Moderate severity substance-use disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gopalkumar Rakesh

OTHER

Sponsor Role: lead

Responsible Party

Gopalkumar Rakesh

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gopalkumar Rakesh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

88372

Identifier Type: -

Identifier Source: org_study_id