Apply tACS to Alleviate Anxiety Symptoms

Description

This is a clinical research trial exploring the efficacy of non-invasive neuromodulation (NM) intervention in the treatment of anxiety. The NM used in this study consists of 25 minutes of 5 hz transcranial alternating current stimulation (tACS) titrated up to 2mA targeting the anterolateral amygdala across 12 treatment sessions with a 3-4 week time period. The studied population includes patients with the following anxiety disorders: generalized anxiety disorder (GAD), social anxiety disorder (SAD), separation anxiety disorder of childhood, and post-traumatic stress disorder (PTSD). Participants will be randomly assigned to tACS or sham, cross-over, then followed by an optional open-label extension phase.

Conditions

Anxiety Disorders

Study Overview

Study Details

Study overview

This is a clinical research trial exploring the efficacy of non-invasive neuromodulation (NM) intervention in the treatment of anxiety. The NM used in this study consists of 25 minutes of 5 hz transcranial alternating current stimulation (tACS) titrated up to 2mA targeting the anterolateral amygdala across 12 treatment sessions with a 3-4 week time period. The studied population includes patients with the following anxiety disorders: generalized anxiety disorder (GAD), social anxiety disorder (SAD), separation anxiety disorder of childhood, and post-traumatic stress disorder (PTSD). Participants will be randomly assigned to tACS or sham, cross-over, then followed by an optional open-label extension phase.

Non-invasive Neuromodulation of the Right Anterior Amygdala Using tACS: A Double-blind Randomized Sham Controlled Clinical Trial for the Treatment of Anxiety Related Disorders With an Open-Label Extension

Apply tACS to Alleviate Anxiety Symptoms

Condition
Anxiety Disorders
Intervention / Treatment

-

Contacts and Locations

Mount Arlington

NCI Clinical Research Foundation, Mount Arlington, New Jersey, United States, 07856

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Meet SCID-5/MINI KID criteria for one of the above-mentioned anxiety disorders.
  • * Subject, or legally acceptable representative (LAR), is able to read, understand, and provide written informed consent and assent, as applicable.
  • * Subjects requiring an LAR will have an identified caregiver who meets the following criteria: Able to reliably report and communicate on the subject's level of functioning and either lives with the subject or sees the subject on average for ≥ 3 hours/day ≥ 4 days/week, or receives reports from a caregiver, such as an aide, who meets this criteria, and in the investigator's opinion - the extent of contact is sufficient to provide meaningful assessment of changes in subject behavior and function over time
  • * Able to be compliant with all study procedures
  • * Age range: 5 years of age or older
  • * Stable medications for non-excluded concurrent medical conditions for eight weeks prior to randomization
  • * If receiving psychotherapy, participants must have started psychotherapy at least 2 months prior to randomization
  • * Health: Physically acceptable for the study with no expected medical conditions likely to occur during or immediately after the study, as confirmed by medical history
  • * Clinical laboratory values of TSH and T4, within 90 days from randomization must be within normal limits or judged not clinically related by the physician sub-investigator or PI to the subject's cognitive impairment if abnormalities are present.
  • 1. Neurodegenerative disease
  • 2. Epilepsy
  • 3. Intellectual Disability
  • 4. Pregnancy or lactation
  • 5. Convexity skull defects
  • 6. Raised intracranial pressure
  • 7. Intracranial electrodes
  • 8. Vascular clips or shunts in the brain
  • 9. Cardiac pacemakers or other implanted biomedical devices
  • 10. An active medical disorder that could explain, in the opinion of the PI or by medical history, the anxiety disorder.
  • 11. Had an abrupt and significant change in functioning within 3 months of randomization.
  • 12. Meets criteria for any substance use addiction as defined by DSM-5/SCID-5 CV.
  • 13. Active alcoholism as defined by 3 or more bottles of beer or glasses of wine or 2 hard liquor drinks per day/night 3 or \> times per week at any time within the past 12 weeks of screening or any other addiction to non-prescription substances.
  • 14. Schizophrenia spectrum disorders and bipolar spectrum disorders.
  • 15. Active suicidal tendency (evaluated by Columbia-Suicide Severity Rating Scale \[C-SSRS\], traditional version). Note: If the BDI or CDS of the participants significantly increase, the CSSRS will be repeated.
  • 16. Unstable medical condition (including expected medication change/titration).
  • 17. Premenstrual dysphoric disorder.
  • 18. Factious/malingering disorder and any patients applying for disability warranty.
  • 19. Somatoform disorders subtypes: conversion and hypochondriasis.

Ages Eligible for Study

5 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NeuroCognitive and Behavioral Institute Clinical Research Foundation,

Gerald Tramontano, PRINCIPAL_INVESTIGATOR, NCI Clinical Research Foundation

Study Record Dates

2024-12-31