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

April 11, 2024 updated by: Carter Bedford, Florida State University
Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Florida State University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent theta burst stimulation to right dorsolateral prefrontal cortex
Participants will receive intermittent theta burst stimulation (iTBS) to the experimental target area, the right dorsolateral prefrontal cortex (rDLPFC)
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.
Active Comparator: Intermittent theta burst stimulation to vertex of the skull
Participants will receive intermittent theta burst stimulation (iTBS) to the active comparator area, the vertex of the skull
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Investigators

  • Principal Investigator: Norman B Schmidt, PhD, Distinguished Research Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2023

Primary Completion (Actual)

February 3, 2024

Study Completion (Actual)

February 3, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003574

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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