Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in Humans

ConditionPTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe University of Texas Health Science Center, Houston

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Transcranial magnetic stimulation (TMS)

    Device

    Research 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

    Behavioral

    Participants 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

250 Participants
are divided into 1 treatment group
Group A: Fear Conditioning and Extinction Paradigm, plus Transcranial Magnetic Stimulation (TMS)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Experimental Day 1
2

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.

Time frame
Experimental Day 3
3

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.

Time frame
Experimental Day 1
4

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.

Time frame
Experimental Day 3

Secondary outcomes

1

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).

Time frame
Experimental Day 1
2

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).

Time frame
Experimental Day 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator