RECRUITING

A Neurosensory Account of Anxiety and Stress (Study 1)

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2022-04-05
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05895006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Right-handed
  2. * With normal or corrected-to-normal vision and normal olfaction
  3. * Between the ages of 18 and 50 years
  4. * Meeting the tACS screening criteria (see List I below; e.g., lack of a serious head injury or loss of consciousness)
  5. * Patients: Diagnosis of PTSD
  6. * Patients: If taking psychotropic medications, medication stability in the past 2 months
  7. * If having mild substance use disorder (for patients) or occasional substance use, abstention from use 48 hours before the experiment.
  1. * 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).
  2. * Patients: Concurrent Axis I diagnosis (depression, anxiety, and mild substance use disorder are allowed given their high comorbidity with PTSD).
  3. * Healthy controls: A history of diagnosis for a DSM-5 Axis I disorder or current use of psychoactive medications.
  4. * 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.
  5. * History of head trauma with unconsciousness (\> 5 minutes)
  6. * Report that they regularly drink 3 or more alcoholic beverages a day.
  7. * 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.
  8. * 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).
  9. * 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)
  10. * Pregnancy based on urine test. The safety of MR systems has not been established for fetuses
  11. * 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.

Contacts and Locations

Study Contact

Wen Li, PhD
CONTACT
(713) 486-2700
Wen.Li.1@uth.tmc.edu
Jada Malveaux, MA
CONTACT
(713) 486-2700
Jada.Malveaux@uth.tmc.edu

Principal Investigator

Wen Li, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Wen Li, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-05
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-04-05
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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