Apply tACS to Alleviate Anxiety Symptoms

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Anxiety Disorders

In brief

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.

Key facts

Study ID

NCT06086015

Run by

NeuroCognitive and Behavioral Institute Clinical Research Foundation

People needed

40

Starts

2021-06-01

Expected to finish

2024-12-31

Last updated by the study team

2023-10-18

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NCI Clinical Research Foundation — Mount Arlington, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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