Recruiting

Observational StudyA Neurosensory Account of Anxiety and Stress (Study 1)

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05895006

Conditions

Posttraumatic Stress Disorder (PTSD)

Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Alternating Current Stimulation (tACS)

Sham for Transcranial Alternating Current Stimulation (tACS)

Transcranial Random Noise stimulation (tRNS)

Study Details

Brief 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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition

Study ID

NCT05895006

Start date

Apr 5, 2022

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcranial Alternating Current Stimulation (tACS)

sham comparator: Sham for Transcranial Alternating Current Stimulation (tACS)

active comparator: Active Control - Transcranial Random Noise stimulation (tRNS)

Interventions

Alternating 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.

Sham 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.

Transcranial 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.

Primary outcome measure

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) ]
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) ]

Central Contacts and Locations

Central contacts

Wen Li, PhD

(713) 486-2700 Wen.Li.1@uth.tmc.edu

Jada Malveaux, MA

(713) 486-2700 Jada.Malveaux@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Wen Li, PhD

(713) 486-2700 Wen.Li.1@uth.tmc.edu

Jada Malveaux, PhD

(713) 486-2700 Jada.Malveaux@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-09-12.