Last updated: October 16, 2023
Sponsor: NeuroCognitive and Behavioral Institute Clinical Research Foundation
Overall Status: Active - Recruiting
Phase
2
Condition
Anxiety Disorders
Panic Disorders
Mood Disorders
Treatment
transcranial alternating current stimulation (tACS)
Clinical Study ID
NCT06086015
AMG-05
Ages > 5 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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, andprovide written informed consent and assent, as applicable.
- Subjects requiring an LAR will have an identified caregiver who meets the followingcriteria: Able to reliably report and communicate on the subject's level offunctioning and either lives with the subject or sees the subject on average for ≥ 3hours/day ≥ 4 days/week, or receives reports from a caregiver, such as an aide, whomeets this criteria, and in the investigator's opinion - the extent of contact issufficient to provide meaningful assessment of changes in subject behavior andfunction 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 weeksprior to randomization
- If receiving psychotherapy, participants must have started psychotherapy at least 2months prior to randomization
- Health: Physically acceptable for the study with no expected medical conditions likelyto 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 bewithin normal limits or judged not clinically related by the physiciansub-investigator or PI to the subject's cognitive impairment if abnormalities arepresent.
Exclusion
Exclusion Criteria:
- Neurodegenerative disease
- Epilepsy
- Intellectual Disability
- Pregnancy or lactation
- Convexity skull defects
- Raised intracranial pressure
- Intracranial electrodes
- Vascular clips or shunts in the brain
- Cardiac pacemakers or other implanted biomedical devices
- An active medical disorder that could explain, in the opinion of the PI or by medicalhistory, the anxiety disorder.
- Had an abrupt and significant change in functioning within 3 months of randomization.
- Meets criteria for any substance use addiction as defined by DSM-5/SCID-5 CV.
- Active alcoholism as defined by 3 or more bottles of beer or glasses of wine or 2 hardliquor drinks per day/night 3 or > times per week at any time within the past 12 weeksof screening or any other addiction to non-prescription substances.
- Schizophrenia spectrum disorders and bipolar spectrum disorders.
- Active suicidal tendency (evaluated by Columbia-Suicide Severity Rating Scale [C-SSRS], traditional version). Note: If the BDI or CDS of the participantssignificantly increase, the CSSRS will be repeated.
- Unstable medical condition (including expected medication change/titration).
- Premenstrual dysphoric disorder.
- Factious/malingering disorder and any patients applying for disability warranty.
- Somatoform disorders subtypes: conversion and hypochondriasis.
Study Design
Total Participants: 40
Treatment Group(s): 1
Primary Treatment: transcranial alternating current stimulation (tACS)
Phase: 2
Study Start date:
June 01, 2021
Estimated Completion Date:
December 31, 2024
Connect with a study center
NCI Clinical Research Foundation
Mount Arlington, New Jersey 07856
United StatesActive - Recruiting
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