Post Traumatic Stress DisorderNCT06100731
tDCS and Inhibitory Control in PTSD
A study testing tDCS in people with Post Traumatic Stress Disorder, run by Gopalkumar Rakesh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2023to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- History of seizures
- Current pregnancy
- Moderate severity substance-use disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of Transcranial Direct Current Stimulation on Inhibitory Control in PTSD
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.
Read the 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
- Being tested
- tDCS
- Keywords
- noninvasive brain stimulation, inhibitory control, transcranial direct current stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Starstim®, transcranial direct current stimulation, transcranial electrical stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start27 Oct 2023
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to receive Active (real) or Sham (placebo) transcranial direct current stimulation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gopalkumar Rakesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gopalkumar Rakesh, University of Kentucky
- Investigators
- Gopalkumar Rakesh, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100731
- Sponsor's protocol ID
- 88372
- Status last verified
- Jan 2025
- First submitted
- 4 Oct 2023
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Transcranial Direct Current Stimulation on Inhibitory Control in PTSD
- ClinicalTrials.gov ID
- NCT06100731
- Acronym / sponsor ID
- 88372
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- noninvasive brain stimulation, inhibitory control, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Gopalkumar RakeshUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to receive Active (real) or Sham (placebo) transcranial direct current stimulation.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: tDCSCurrent 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 |
| Shame tDCS | Sham comparator | Device: tDCSCurrent 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: Starstim®, transcranial direct current stimulation, transcranial electrical stimulationSubjects 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. | Device | Active tDCS, Shame tDCS |
Primary outcome
Stop Signal Reaction Time (SSRT)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: Yes. 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
Related trials for Post Traumatic Stress Disorder
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gopalkumar Rakesh, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Post Traumatic Stress Disorder, run by Gopalkumar Rakesh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop Signal Reaction Time (SSRT) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.