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

Primary Purpose

PTSD

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for PTSD focused on measuring Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida State University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent theta burst stimulation to right dorsolateral prefrontal cortex

Intermittent theta burst stimulation to vertex of the skull

Arm Description

Participants will receive intermittent theta burst stimulation (iTBS) to the experimental target area, the right dorsolateral prefrontal cortex (rDLPFC)

Participants will receive intermittent theta burst stimulation (iTBS) to the active comparator area, the vertex of the skull

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 23, 2023
Last Updated
September 28, 2023
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT06016673
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant will receive stimulation to two brain areas (right dorsolateral prefrontal cortex and vertex) in a counterbalanced order.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent theta burst stimulation to right dorsolateral prefrontal cortex
Arm Type
Experimental
Arm Description
Participants will receive intermittent theta burst stimulation (iTBS) to the experimental target area, the right dorsolateral prefrontal cortex (rDLPFC)
Arm Title
Intermittent theta burst stimulation to vertex of the skull
Arm Type
Active Comparator
Arm Description
Participants will receive intermittent theta burst stimulation (iTBS) to the active comparator area, the vertex of the skull
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
Participants will receive intermittent theta burst stimulation (iTBS) to two brain areas, the right dorsolateral prefrontal cortex (rDLPFC) and the vertex.
Primary Outcome Measure Information:
Title
Performance on emotional working memory task
Description
Accuracy and reaction time on a task measuring working memory in the presence of trauma-related distractor images
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman B Schmidt, PhD
Organizational Affiliation
Distinguished Research Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University College of Medicine
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

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

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