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RecruitingNCT05895006Updated Sep 12, 2025

A Neurosensory Account of Anxiety and Stress (Study 1)

An interventional study of Alternating Current Stimulation (tACS) and Sham for Transcranial Alternating Current Stimulation (tACS) in Posttraumatic Stress Disorder (PTSD) and Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Apr 2022, registered Apr 2023).
  • Started Apr 2022; still recruiting 4 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Posttraumatic Stress Disorder (PTSD)
  • Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition
03

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's planned enrollment of 160 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Transcranial Alternating Current Stimulation (tACS)

    Device: Alternating Current Stimulation (tACS)

  • Sham comparator
    Sham for Transcranial Alternating Current Stimulation (tACS)

    Device: Sham for Transcranial Alternating Current Stimulation (tACS)

  • Active comparator
    Active Control - Transcranial Random Noise stimulation (tRNS)

    Device: Transcranial Random Noise stimulation (tRNS)

Interventions

  • DeviceAlternating Current Stimulation (tACS)

    A weak electrical current will be passed through the scalp over targeted cortical regions via a transcranial electrical stimulation system (Soterix Medical, Inc), for a span of 10 to 40 minutes at a time. Participants will receive a 2 milliamp (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. Current intensities will be modified to address individual participants' subjective reports of discomfort, with a maximum intensity of 2 mA. Stimulation electrodes will be placed within an EEG cap fitted over the participant's head.

  • DeviceSham for Transcranial Alternating Current Stimulation (tACS)

    Stimulation electrodes will be placed on the scalp, but no current will be passed. Stimulation electrodes will be placed within an EEG cap fitted over the participant's head.

  • DeviceTranscranial Random Noise stimulation (tRNS)

    A weak electrical currents will be passed through the scalp over targeted cortical regions via a transcranial electrical stimulation system (Soterix Medical, Inc), for a span of 10 to 40 minutes at a time. Participants will receive a 2 mA sinusoidal current oscillating at random frequency (1-200 Hz). Current intensities will be modified to address individual participants' subjective reports of discomfort, with a maximum intensity of 2 mA. Stimulation electrodes will be placed within an EEG cap fitted over the participant's head.

06

What researchers measure

Primary outcomes

  1. Change in neural oscillatory activity as assessed by electroencephalogram (EEG) alpha power change

    Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)

  2. Change in cortical activity as assessed by functional magnetic resonance imaging (fMRI) blood-oxygen-level dependent (BOLD) signal change

    Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)

Secondary outcomes

  1. Change in salience detection and vigilance behavior as assessed by percent accuracy on an oddball detection task

    Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)

  2. Change in salience detection and vigilance behavior as assessed by reaction time in milliseconds (ms) on an oddball detection task

    Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)

  3. Change in salience detection and vigilance behavior as assessed by skin conductance measured in microsiemens (μS)

    Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)

07

Study locations

1 of 1 sites recruiting
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication.

Supporting information: Study protocol, Sap, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05895006
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Wen Li (Associate professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jun 8, 2023
Start date
Apr 5, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 12, 2025

Study contacts

Wen Li, PhD
Contact
Wen.Li.1@uth.tmc.edu
(713) 486-2700
Jada Malveaux, MA
Contact
Jada.Malveaux@uth.tmc.edu
(713) 486-2700
Wen Li, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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