A Neurosensory Account of Anxiety and Stress (Study 1)

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT05895006
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Apr 5, 2022
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Wen Li, PhD
(713) 486-2700
Jada Malveaux, PhD
(713) 486-2700

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