About this trial
This study aims to explore the mechanisms of how transcranial magnetic stimulation (TMS) impacts fear circuits. The overarching objectives are to understand how varying TMS parameters affect targeted brain regions in order to optimize its impact on enhancing fear extinction memory consolidation in a population with known fear extinction deficiencies: post-traumatic stress disorder (PTSD). 250 subjects will take part in this research study across UTHealth Houston. The study will include preliminary screenings, baseline visits, and experimental visits across four days
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Willing and able to provide informed consent.
Inclusion Criteria for PTSD Subjects - Diagnosis of current PTSD
Inclusion Criteria: Healthy Controls (HC) - no current psychiatric disorders ("Axis I" disorders)
Disqualifiers
Lifetime history of seizure or significant head trauma or other significant neurologic disease (e.g., tic disorder)
History of serious/significant psychiatric diagnoses ("Axis I" diagnoses)
Current significant suicidal ideation, plan or intent or suicidal behavior in past 6 months based on CSSRS and clinical judgment or Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily
Use of neuroleptics within one year prior to study
Trial design
Single group
Treatments tested in this trial
Transcranial magnetic stimulation (TMS)
DeviceResearch subjects will undergo non-invasive TMS, with a frequency of 20Hz and intensity of 120% of their resting motor threshold (rMT) at varying time points and locations.
Fear Conditioning and Extinction Paradigm
BehavioralParticipants will undergo a 3-day experimental paradigm. On day 1, participants will undergo a resting-state and structural scans in the fMRI scanner. The data from this scan will be used to determine the specific location of the TMS target for each participant. And participants will be aversively conditioned to two cues in the fMRI scanner. Task based and resting-state scans will occur on this day. On day 2, subjects will undergo extinction training outside of the scanner where one of the conditioned cues will be paired with TMS in a temporally and anatomically specific manner. A resting-state scan will occur before and after inside the scanner. On day 3, conditioned cues will be presented during the extinction recall phase of the study. This phase will be conducted in the fMRI scanner. Task-based and resting-state scans will occur on this day.
Treatment groups
Trial outcomes
Primary outcomes
Skin Conductance Response (SCR)
Conductance is measured by placing two electrodes next to the skin and passing a tiny electric charge between the two points. SCR is proportionally related to the number of sweat glands that are activated, meaning in essence that the more emotionally aroused an individual is, the more the SCR amount is increased.
Skin Conductance Response (SCR)
Conductance is measured by placing two electrodes next to the skin and passing a tiny electric charge between the two points. SCR is proportionally related to the number of sweat glands that are activated, meaning in essence that the more emotionally aroused an individual is, the more the SCR amount is increased.
Functional MRI (fMRI) blood-oxygen-level-dependent (BOLD) responses
fMRI data, including blood-oxygen-level-dependent (BOLD) responses, is used in neuroimaging studies assess neural correlate activations and observe the increase/decrease in activation of a particular brain area in response to a specific cue. When these cells are active, there is an increase in blood oxygen in the surrounding area.
Functional MRI (fMRI) blood-oxygen-level-dependent (BOLD) responses
fMRI data, including blood-oxygen-level-dependent (BOLD) responses, is used in neuroimaging studies assess neural correlate activations and observe the increase/decrease in activation of a particular brain area in response to a specific cue. When these cells are active, there is an increase in blood oxygen in the surrounding area.
Secondary outcomes
Score on State-Trait Anxiety Inventory (STAI) - Form Y1
STAI - Form Y1 is a commonly used measure of trait and state anxiety that consists of 20 statements that describe oneself. Each statement is scored from 1 (Not at all) to 4 (very much so). The total score range is 20-80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Score on State-Trait Anxiety Inventory (STAI) - Form Y1
STAI - Form Y1 is a commonly used measure of trait and state anxiety that consists of 20 statements that describe oneself. Each statement is scored from 1 (Not at all) to 4 (very much so). The total score range is 20-80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Sponsors and contacts
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The University of Texas Health Science Center, Houston
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator