A Neurosensory Account of Anxiety and Stress (Study 1)
NCT05895006 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2025-09-12
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
Interventions
- 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.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
The University of Texas Health Science Center, Houston
lead OTHER
Principal Investigators
-
Wen Li, PhD · The University of Texas Health Science Center, Houston
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-04-05
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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