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

NCT06016673 | Completed

• 1 other identifier: STUDY00003574
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PTSD

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intermittent theta burst stimulation to right dorsolateral prefrontal cortex

EXPERIMENTAL

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

Procedure: Transcranial Magnetic Stimulation (TMS)

Intermittent theta burst stimulation to vertex of the skull

ACTIVE COMPARATOR

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

Procedure: Transcranial Magnetic Stimulation (TMS)

Interventions

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.

Intermittent theta burst stimulation to right dorsolateral prefrontal cortex; Intermittent theta burst stimulation to vertex of the skull

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[PCL-5\]).

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University College of Medicine

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Norman B Schmidt, PhD

  Distinguished Research Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant will receive stimulation to two brain areas (right dorsolateral prefrontal cortex and vertex) in a counterbalanced order.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 30, 2023
• Study Start: September 13, 2023
• Primary Completion: February 3, 2024
• Study Completion: February 3, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

US (1)