NCT05895006 A Neurosensory Account of Anxiety and Stress (Study 1)
| NCT ID | NCT05895006 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Posttraumatic Stress Disorder (PTSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-04-05 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-04-05 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 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 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.
Contact & Investigator
Wen Li, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT05895006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Posttraumatic Stress Disorder (PTSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05895006 currently recruiting?
Yes, NCT05895006 is actively recruiting participants. Contact the research team at Wen.Li.1@uth.tmc.edu for enrollment information.
Where is the NCT05895006 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05895006 clinical trial?
NCT05895006 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Wen Li, PhD at The University of Texas Health Science Center, Houston. The trial plans to enroll 160 participants.
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