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

Sponsor
Florida State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06016673
Collaborator
(none)
35
Enrollment
2
Arms
23.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transcranial Magnetic Stimulation (TMS)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Each participant will receive stimulation to two brain areas (right dorsolateral prefrontal cortex and vertex) in a counterbalanced order.Each participant will receive stimulation to two brain areas (right dorsolateral prefrontal cortex and vertex) in a counterbalanced order.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)
Anticipated Study Start Date :
Aug 28, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Florida State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carter Bedford, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier:
NCT06016673
Other Study ID Numbers:
  • STUDY00003574
First Posted:
Aug 30, 2023
Last Update Posted:
Sep 5, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carter Bedford, Principal Investigator, Florida State University
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Sep 5, 2023