Status:
UNKNOWN
Apply tACS to Alleviate Anxiety Symptoms
Lead Sponsor:
NeuroCognitive and Behavioral Institute Clinical Research Foundation
Conditions:
Anxiety Disorders
Eligibility:
All Genders
5+ years
Phase:
PHASE2
Brief Summary
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 transcr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 medical history, 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 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.
- 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 participants significantly 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06086015
Start Date
June 1 2021
End Date
December 31 2024
Last Update
October 18 2023
Active Locations (1)
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1
NCI Clinical Research Foundation
Mount Arlington, New Jersey, United States, 07856