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

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Procedure: Transcranial Magnetic Stimulation (TMS)

• Registration Number: NCT06016673
• Lead Sponsor: Florida State University

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).

Study Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-08-30
• Study Start: 2023-09-13
• Primary Completion: 2024-02-03
• Study Completion: 2024-02-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intermittent theta burst stimulation to vertex of the skull	Transcranial Magnetic Stimulation (TMS)	Participants will receive intermittent theta burst stimulation (iTBS) to the active comparator area, the vertex of the skull
Intermittent theta burst stimulation to right dorsolateral prefrontal cortex	Transcranial Magnetic Stimulation (TMS)	Participants will receive intermittent theta burst stimulation (iTBS) to the experimental target area, the right dorsolateral prefrontal cortex (rDLPFC)

Primary Outcome Measures

Name	Time	Method
Performance on emotional working memory task	5 hours	Accuracy and reaction time on a task measuring working memory in the presence of trauma-related distractor images

Trial Locations

Locations (1)

Florida State University College of Medicine; 🇺🇸 Tallahassee, Florida, United States