A Neurosensory Account

Last updated: March 5, 2025
Sponsor: Florida State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

alpha-frequency tACS

Random noise stimulation

Clinical Study ID

NCT05895006
101931
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 headinjury or loss of consciousness)

  • Patients: Diagnosis of PTSD

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

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

Exclusion

Exclusion Criteria:

  • A history of diagnosis for a major medical illness (e.g., cancer, metabolicsyndrome, 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 usedisorder are allowed given their high comorbidity with PTSD).

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

  • Severe psychiatric instability or severe situational life crises, including evidenceof being actively suicidal or homicidal, or any behavior that poses an immediatedanger 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 beingscanned.

  • 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-hourperiod prior to scanning (to exclude the impact of these medications on theinterpretation of fMRI/EEG).

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

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

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

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: alpha-frequency tACS
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
October 31, 2027

Study 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

Connect with a study center

  • Leon County

    Tallahassee, Florida 32306
    United States

    Active - Recruiting

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