A Neurosensory Account of Anxiety and Stress (Study 2)

NCT07079839 | Recruiting FDA Device

• 2 other identifiers: HSC-MS-23-1106 (study 2)R01MH132209
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Threat-related Sensory Cortical (SC) Disinhibition; Posttraumatic Stress Disorder (PTSD)

Outcome Measures

Primary Outcomes (2)

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

  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

  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

  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

  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

  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

  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)

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

Study Arms (3)

Transcranial Alternating Current Stimulation (tACS)

EXPERIMENTAL

Device: Transcranial Alternating Current Stimulation (tACS)

Sham for Transcranial Alternating Current Stimulation (tACS)

SHAM COMPARATOR

Device: Sham for Transcranial Alternating Current Stimulation (tACS)

Active Control - Transcranial Random Noise stimulation (tRNS)

ACTIVE COMPARATOR

Device: Transcranial Random Noise stimulation (tRNS)

Interventions

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.

Transcranial Alternating Current Stimulation (tACS)

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.

Sham for Transcranial Alternating Current Stimulation (tACS)

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.

Active Control - Transcranial Random Noise stimulation (tRNS)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wen Li, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 23, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Starting 6 months after publication.
• Access Criteria: All researchers.

Locations

US (1)