A Neurosensory Account of Anxiety and Stress (Study 2)

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-50

SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

160 Participants

are divided into 3 treatment groups

Group A: Transcranial Alternating Current Stimulation (tACS)Experimental treatment 1 intervention

Group B: Sham for Transcranial Alternating Current Stimulation (tACS)Sham comparator 1 intervention

Group C: Active Control - Transcranial Random Noise stimulation (tRNS)Active comparator 1 intervention