A Neurosensory Account

Post Traumatic Stress Disorder Clinical Trial

Official title:

A Neurosensory Account of PTSD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895006
• Other study ID #: 101931
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: October 2027

Study information

• Verified date: October 2023
• Source: Florida State University
• Contact: Wen Li, PhD
• Phone: 850-645-1409
• Email: wenli[@]psy.fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to develop and test a novel pathophysiology of PTSD by integrating sensory cortical (SC) and amygdala-PFC dysfunctions into a tripartite Sensory-Prefrontal-Cortex-Amygdala (SPA) model.

Description:

This study includes Expt. 1a & Expt. 1b to address Aims 1& 2--intrinsic and novelty-related SC disinhibition and SPA pathology in PTSD.

The investigators will recruit 80 healthy subjects and 80 patients with PTS randomized, double-blind, controlled design, where tACS will be delivered at individual alpha peak frequency (active condition) and random frequency (1-200 Hz; random noise stimulation/RNS; active control condition), randomly assigned across subjects in each group. Simultaneous EEG- fMRI recordings during the resting state (Expt. 1a) and during the novelty task (Expt. 1b) will be acquired before and after tACS/RNS.

During tACS/RNS, stimulation electrodes will be placed inside the holders of the BrainProducts EEG cap attached to the head of the participant. A very weak (completely tolerable and often unnoticeable) electrical current will be applied to the scalp via the stimulation electrodes.

Overall, this study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Right-handed

• With normal or corrected-to-normal vision and normal olfaction

• Between the ages of 18 and 50 years

• Meeting the tACS screening criteria (see List I below; e.g., lack of a serious head injury or loss of consciousness)

• Patients: Diagnosis of PTSD

• Patients: If taking psychotropic medications, medication stability in the past 2 months

• If having mild substance use disorder (for patients) or occasional substance use, abstention from use 48 hours before the experiment.

Exclusion Criteria:

• A history of diagnosis for a major medical illness (e.g., cancer, metabolic syndrome, cardiovascular disease, inflammatory disorders) or a neurological disorder (e.g., seizure, stroke, Parkinson's disease).

• Patients: Concurrent Axis I diagnosis (depression, anxiety, and mild substance use disorder are allowed given their high comorbidity with PTSD).

• Healthy controls: A history of diagnosis for a DSM-5 Axis I disorder or current use of psychoactive medications.

• Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior that poses an immediate danger to self or others.

• History of head trauma with unconsciousness (> 5 minutes)

• Report that they regularly drink 3 or more alcoholic beverages a day.

• Report that they are unable to abstain from substance use (including alcohol, nicotine, cannabis, amphetamines, narcotics, solvents, cocaine, hallucinogens, tranquilizers, barbiturates, etc.) or sleep medication for 48 hours before being scanned.

• Are on calcium channel blockers (e.g., verapamil, nifedipine) or alpha-blockers (e.g., prazosin, terazosin) and are unable to stop these medications for a 48-hour period prior to scanning (to exclude the impact of these medications on the interpretation of fMRI/EEG).

• Failed Urine Drug Screening Test: A rapid urine screening test that utilizes monoclonal antibodies to detect elevated levels of specific drugs (including alcohol, amphetamines, benzodiazepines, barbiturates, cocaine, marijuana, opiates, etc.) in urine (iCup)

• Pregnancy based on urine test. The safety of MR systems has not been established for fetuses

• Having electrically, magnetically, or mechanically activated implants (e.g., cardiac pacemakers), because the electromagnetic fields produced by the MR system may interfere with the operation of these devices.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• alpha-frequency tACS
The investigators will apply a 2 mA sinusoidal current oscillating at individual participants' baseline peak alpha frequencies (PAF; 7-13 Hz), which will be determined by a 3-min resting state EEG recording during the setup.
• Random noise stimulation
The investigators will apply a 2 mA sinusoid current oscillating at random frequency (1-200 Hz).

Locations

Country	Name	City	State
United States	Leon County	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neural response in the SPA circuitry	Spontaneous and Expt. 1b task-induced activity in the SPA circuitry (i.e., sensory cortex, prefrontal cortex, and amygdala), measured with EEG and fMRI.; Measure Alpha power change	Change from Baseline/Pre- to immediately post-tACS
Primary	Neural response in the SPA circuitry	Spontaneous and Expt. 1b task-induced activity in the SPA circuitry (i.e., sensory cortex, prefrontal cortex, and amygdala), measured with EEG and fMRI.; Measure BOLD signal change	Change from Baseline/Pre- to immediately post-tACS
Secondary	Salience detection and vigilance behavior	In Expt. 1b., Measure Oddball detection accuracy, (%)	Change from Baseline/Pre- to immediately post-tACS
Secondary	Salience detection and vigilance behavior	In Expt. 1b., Measure Reaction time, (ms)	Change from Baseline/Pre- to immediately post-tACS
Secondary	Salience detection and vigilance behavior	In Expt. 1b., Measure Skin conductance response/level, (µS)	Change from Baseline/Pre- to immediately post-tACS