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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06016673
• Other study ID #: STUDY00003574
• Status: Completed
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: February 3, 2024

Study information

• Verified date: April 2024
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 3, 2024
• Est. primary completion date: February 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Procedure:
• Transcranial Magnetic Stimulation (TMS)
Participants will receive intermittent theta burst stimulation (iTBS) to two brain areas, the right dorsolateral prefrontal cortex (rDLPFC) and the vertex.

Locations

Country	Name	City	State
United States	Florida State University College of Medicine	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on emotional working memory task	Accuracy and reaction time on a task measuring working memory in the presence of trauma-related distractor images	5 hours