PTSDNCT06016673
Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)
A study testing Transcranial Magnetic Stimulation (TMS) in people with PTSD, run by Florida State University at 1 site in United States.
Trial summary
Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 3 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]).
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University College of Medicine
Tallahassee, Florida, 32306
About this study
Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)
Read the 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).
- Conditions
- PTSD
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- Transcranial Magnetic Stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Procedure or surgery
Participants will receive intermittent theta burst stimulation (iTBS) to two brain areas, the right dorsolateral prefrontal cortex (rDLPFC) and the vertex.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Procedure: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on emotional working memory task
Accuracy and reaction time on a task measuring working memory in the presence of trauma-related distractor images
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start13 Sep 2023
- Primary completion3 Feb 2024
- Study completion3 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carter Bedford, Florida State University
- Investigators
- Norman B Schmidt, PhD, Principal investigator, Distinguished Research Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016673
- Sponsor's protocol ID
- STUDY00003574
- Status last verified
- Apr 2024
- First submitted
- 23 Aug 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT06016673
- Acronym / sponsor ID
- STUDY00003574
- Conditions
- PTSD
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 3 Feb 2024 (actual)
- Study completion
- 3 Feb 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will receive stimulation to two brain areas (right dorsolateral prefrontal cortex and vertex) in a counterbalanced order.
| Arm | Type | Receives |
|---|---|---|
| Intermittent theta burst stimulation to right dorsolateral prefrontal cortex | Experimental | Procedure: Transcranial Magnetic Stimulation (TMS)Participants will receive intermittent theta burst stimulation (iTBS) to the experimental target area, the right dorsolateral prefrontal cortex (rDLPFC) |
| Intermittent theta burst stimulation to vertex of the skull | Active comparator | Procedure: Transcranial Magnetic Stimulation (TMS)Participants will receive intermittent theta burst stimulation (iTBS) to the active comparator area, the vertex of the skull |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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]).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Intermittent theta burst stimulation to right dorsolateral prefrontal cortex, Intermittent theta burst stimulation to vertex of the skull |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman B Schmidt, PhD principal investigator
Distinguished Research Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with PTSD, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on emotional working memory task (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.