Clinical trial NCT05895006: A Neurosensory Account
Official title: A Neurosensory Account of PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Neural response in the SPA circuitry
timeFrame: Change from Baseline/Pre- to immediately post-tACS
measure: Neural response in the SPA circuitry
timeFrame: Change from Baseline/Pre- to immediately post-tACS
Secondary outcomes:
measure: Salience detection and vigilance behavior
timeFrame: Change from Baseline/Pre- to immediately post-tACS
measure: Salience detection and vigilance behavior
timeFrame: Change from Baseline/Pre- to immediately post-tACS
measure: Salience detection and vigilance behavior
timeFrame: Change from Baseline/Pre- to immediately post-tACS
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Leon County
state: Florida
Study officials:
affiliation: Florida State University
name: Wen Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: