A Neurosensory Account of Anxiety and Stress (Study 1)

Last updated: September 5, 2025
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

alpha-frequency tACS

Transcranial Random Noise stimulation (tRNS)

Random noise stimulation

Clinical Study ID

NCT05895006
HSC-MS-23-1106 (study 1)
R01MH132209
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD. Additionally, the study aims to identify how Transcranial Alternating Current Stimulation (tACS) brain stimulation can modulate and correct neural networks and related emotions of anxious arousal and hypervigilance, with the goal of assessing tACS brain stimulation technology as a novel intervention for symptoms of anxiety.

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): 5
Primary Treatment: alpha-frequency tACS
Phase:
Study Start date:
April 05, 2022
Estimated Completion Date:
December 31, 2026

Study Description

This study includes experiments 1a & 1b to address Aims 1 and -- Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition and Sensory-Prefrontal-cortex-Amygdala (SPA) pathology in PTSD. The goal of this study is to develop and test a novel pathophysiology of PTSD by integrating sensory cortical (SC) and amygdala-prefrontal cortex (PFC) dysfunctions into a tripartite Sensory-Prefrontal-Cortex-Amygdala (SPA) model.

The investigators will recruit 80 healthy subjects and 80 patients with PTSD in a randomized, double-blind, controlled design, where they be randomly assigned to 1) Transcranial Alternating Current Stimulation (tACS) at individual alpha peak frequency (active condition); 2) sham control tACS; or 3) active control, which will be transcranial random noise stimulation (tRNS) (random frequency 1-200 Hz). During tACS/sham tACS/tRNS stimulation, stimulation electrodes will be placed inside the holders of an EEG cap attached to the head of the participant. Simultaneous EEG- fMRI recordings during the resting state (in experiment 1a) and during a novelty task (in experiment 1b) will be acquired before and after tACS/tRNS stimulation.

Connect with a study center

  • Leon County

    Tallahassee, Florida 32306
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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