NCT05895006

A Neurosensory Account of Anxiety and Stress (Study 1)

Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition and Sensory-Prefrontal-cortex-Amygdala (SPA) Pathology in Posttraumatic Stress Disorder (PTSD) (Aims 1 & 2; Expts. 1a &1b)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2022-04-05
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-06-08
• Last updated: 2025-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study