CClinicalTrials.gg
RecruitingNCT06086015Updated Oct 18, 2023

Apply tACS to Alleviate Anxiety Symptoms

A Phase 2 interventional study of transcranial alternating current stimulation (tACS) in Anxiety Disorders, sponsored by NeuroCognitive and Behavioral Institute Clinical Research Foundation. Recruiting at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by NeuroCognitive and Behavioral Institute Clinical Research Foundation · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Registered 2 years 4 months after the study started (first participant enrolled Jun 2021, registered Oct 2023).
  • Started Jun 2021; still recruiting 5 years 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
5 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Anxiety Disorders

Browse trials for

03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

This is the only study on the registry with NeuroCognitive and Behavioral Institute Clinical Research Foundation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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, 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 criteria

Exclusion Criteria:

  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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Active group

    Device: transcranial alternating current stimulation (tACS)

  • Placebo comparator
    Sham group

    Device: transcranial alternating current stimulation (tACS)

Interventions

  • Devicetranscranial alternating current stimulation (tACS)

    2mA tACS over right hemisphere, at positions F4, P4, T8 (10-10 convention)

06

What researchers measure

Primary outcomes

  1. Response rate informed by Beck Anxiety Inventory (BAI)

    BAI is a self-rated scale, with scores ranging from 0 to 63. We will calculate the treatment response rate as (pre-treatment BAI minus post-treatment BAI)/pre-treatment BAI

    Time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.

  2. Hamilton Anxiety Rating Scale (HAMA)

    HAMA is a clinician-rated scale, with scores ranging from 0 to 56. We will calculate the treatment response rate as (pre-treatment HAMA minus post-treatment HAMA)/pre-treatment HAMA. We will compute the average of response rates from HAMA and BAI as the final outcome measure.

    Time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.

Secondary outcomes

  1. PTSD Checklist (PCL) for PTSD cohort

    For the PTSD patients, in addition to anxiety measurement, we will also use PCL (ranges from 0 to 80) to register the symptom severity change. Again, the outcome measure is the treatment response rate, defined as pre-treatment PCL minus post-treatment PCL)/pre-treatment PCL

    Time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.

07

Study locations

1 of 1 sites recruiting
  • NCI Clinical Research Foundation
    Mount Arlington, New Jersey 07856, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06086015
Lead sponsor
NeuroCognitive and Behavioral Institute Clinical Research Foundation
Responsible party
Sponsor
First posted
Oct 17, 2023
Start date
Jun 1, 2021
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 18, 2023

Study contacts

Gerald Tramontano, PhD
Contact
gtramontano@neuroci.com
9736010100
Gerald Tramontano
principal investigator · NCI Clinical Research Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion