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

NCT ID: NCT06016673

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-13

Study Completion Date

2024-02-03

Brief Summary

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

Detailed Description

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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).

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will receive stimulation to two brain areas (right dorsolateral prefrontal cortex and vertex) in a counterbalanced order.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS)

Intervention Type 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 vertex of the skull

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

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Carter Bedford

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norman B Schmidt, PhD

Role: PRINCIPAL_INVESTIGATOR

Distinguished Research Professor

Locations

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Florida State University College of Medicine

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00003574

Identifier Type: -

Identifier Source: org_study_id

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