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Completed

NCT Number: NCT06016673

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University College of Medicine

Tallahassee, Florida, 32306, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial magnetic stimulation (TMS)

Procedure

Participants will receive intermittent theta burst stimulation (iTBS) to two brain areas, the right dorsolateral prefrontal cortex (rDLPFC) and the vertex.

Primary outcomes

  1. Performance on emotional working memory task

    Time frame: 5 hours

    Accuracy and reaction time on a task measuring working memory in the presence of trauma-related distractor images

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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