Clinical trial NCT06016673: Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)
Official title: Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Transcranial Magnetic Stimulation
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will receive stimulation to two brain areas (right dorsolateral prefrontal cortex and vertex) in a counterbalanced order.
Primary purpose: BASIC_SCIENCE

Brief summary: Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)

Detailed description: The purpose of the present study is to examine the effects of transcranial magnetic stimulation (TMS) on cognitive control among individuals with posttraumatic stress disorder (PTSD).

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Endorse lifetime exposure to at least one Criterion A traumatic event
* Report clinically significant posttraumatic stress disorder (PTSD) symptoms (score of ≥ 33 on the PTSD Checklist for DSM-5 \[PCL-5\]).

Exclusion Criteria:

* Endorse medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
* Report an unstable medical condition or any current medical condition that precludes safe participation in the trial (e.g., unstable metabolic abnormality, unstable angina, etc.)
* Report any history or diagnosis of dementia or other cognitive disorder, which may interfere with engagement
* Report any history or diagnosis of Severe Traumatic Brain Injury
* Report any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness, which precludes safe participation in the trial
* Report a primary obsessive-compulsive disorder (OCD) diagnosis
* Report an active substance use disorder (within last 3 months) or any current substance use that precludes safe participation in the trial
* Report suicide risk that precludes safe participation in the trial, defined as clinical impression that the participant is at significant risk for suicide (i.e., greater than moderate level of suicide risk, in accordance with the Joiner et al. (1999) suicide risk framework)
* Report an inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
* Report a current, planned, or suspected pregnancy

Primary outcomes:
measure: Performance on emotional working memory task
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University College of Medicine
state: Florida
Study officials:
affiliation: Distinguished Research Professor
name: Norman B Schmidt, PhD
role: PRINCIPAL_INVESTIGATOR
References: