Threat-related Sensory Cortical (SC) DisinhibitionNCT07079839

A Neurosensory Account of Anxiety and Stress (Study 2)

A study testing Transcranial Alternating Current Stimulation (tACS) and Transcranial Random Noise stimulation (tRNS) in people with Threat-related Sensory Cortical (SC) Disinhibition and Posttraumatic Stress Disorder (PTSD), run by The University of Texas Health Science Center, Houston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Threat-related Sensory Cortical (SC) Disinhibition, Posttraumatic Stress Disorder (PTSD)
What is being tested?: Transcranial Alternating Current Stimulation (tACS) and Transcranial Random Noise stimulation (tRNS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteUnited States
Study dates: 3 Jul 2025to Jun 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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 Diagnostic and Statistical Manual of Mental Disorders (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.

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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 magnetic resonance (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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wen Li, PhD contact

(713) 486-2700

Wen.Li.1@uth.tmc.edu

Jada Malveaux, MA contact

(713) 486-2700

Jada.Malveaux@uth.tmc.edu

United States1 site, 1 recruiting

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Wen Li, PhD, (713) 486-2700, Wen.Li.1@uth.tmc.edu
Jada Malveaux, MA, (713) 486-2700, Jada.Malveaux@uth.tmc.edu
Recruiting

Other trials in United States

About this study

Official title: Threat-related Sensory Cortical (SC) Disinhibition and SPA Pathology in Posttraumatic Stress Disorder (PTSD) (Aim 3; Expts. 2&3)

Read the detailed description

This study includes experiments 2 \& 3 to address Aim 3--threat-related 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). Simultaneous EEG/fMRI recordings and behavioral responses will be acquired before and after tACS/sham tACS/tRNS stimulation. 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. Experiments 2 \& 3 include a visual search task and an olfactory detection task, respectively, and both experiments include threat and neutral stimuli.

Conditions: Threat-related Sensory Cortical (SC) Disinhibition, Posttraumatic Stress Disorder (PTSD)
Being tested: Transcranial Alternating Current Stimulation (tACS), Sham for Transcranial Alternating Current Stimulation (tACS), Transcranial Random Noise stimulation (tRNS)
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Alternating Current Stimulation (tACS)Device
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.
Sham for Transcranial Alternating Current Stimulation (tACS)Device
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.
Transcranial Random Noise stimulation (tRNS)Device
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.

Study groups in NCT07079839
Study group	Role	What they receive
Transcranial Alternating Current Stimulation (tACS)	Experimental	Not described Receives: Device: Transcranial Alternating Current Stimulation (tACS)
Sham for Transcranial Alternating Current Stimulation (tACS)	Sham comparator	Not described Receives: Device: Sham for Transcranial Alternating Current Stimulation (tACS)
Active Control - Transcranial Random Noise stimulation (tRNS)	Active comparator	Not described Receives: Device: Transcranial Random Noise stimulation (tRNS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in neural oscillatory activity as assessed by electroencephalogram (EEG) alpha power change
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in cortical activity as assessed by functional magnetic resonance imaging (fMRI) blood-oxygen-level-dependent (BOLD) signal change
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)

Secondary outcomes (5)

Change in visual search as assessed by change in percent accuracy on the visual search experiment
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in visual search as assessed by change in reaction time on the visual search experiment
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in olfactory detection as assessed by change in percent accuracy on the olfactory detection experiment
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in olfactory detection as assessed by change in reaction time on the olfactory detection experiment
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in salience detection and vigilance behavior as assessed by skin conductance measured in microsiemens (μS)
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 2025Jun 2027

First posted23 Jul 2025
Study start3 Jul 2025
Primary completionJun 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Threat-related Sensory Cortical (SC) DisinhibitionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07079839
Sponsor's protocol ID: HSC-MS-23-1106 (study 2)
Other IDs: R01MH132209
Status last verified: Sep 2026
First submitted: 9 Jul 2025
Last updated: 11 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: All IPD that underlie results in a publication.