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Procedure

tACS for Anxiety Disorders

Phase 2

Recruiting

Led By Gerald Tramontano

Research Sponsored by NeuroCognitive and Behavioral Institute Clinical Research Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable medications for non-excluded concurrent medical conditions for eight weeks prior to randomization

Age range: 5 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial explores using a non-invasive intervention to treat anxiety disorders such as GAD, SAD, PTSD, and childhood separation anxiety. Participants are randomly assigned to receive a 25-minute 5 hz tACS or sham, with an optional extension phase.

Who is the study for?

This trial is for individuals aged 5 or older with anxiety disorders like GAD, SAD, PTSD, and separation anxiety. Participants must meet specific diagnostic criteria and be stable on any current medications or psychotherapy. They should have a caregiver if needed and no medical conditions that could interfere with the study.Check my eligibility

What is being tested?

The trial tests transcranial alternating current stimulation (tACS) at 5 hz up to 2mA targeting the brain's amygdala over 12 sessions within a month. It aims to see if tACS can reduce anxiety symptoms compared to sham (placebo-like) treatment, followed by an optional phase where everyone receives tACS.See study design

What are the potential side effects?

Potential side effects of tACS may include discomfort at the electrode sites, mild headaches, dizziness or nausea during or after treatment. These are usually temporary and resolve soon after each session.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My medications for other health conditions have been stable for 8 weeks.

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I am 5 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hamilton Anxiety Rating Scale (HAMA)

Response rate informed by Beck Anxiety Inventory (BAI)

Secondary outcome measures

PTSD Checklist (PCL) for PTSD cohort

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active groupExperimental Treatment1 Intervention

Group II: Sham groupPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

transcranial alternating current stimulation (tACS)

2016

Completed Phase 4

~440

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NeuroCognitive and Behavioral Institute Clinical Research FoundationLead Sponsor

Gerald TramontanoPrincipal InvestigatorNCI Clinical Research Foundation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Active group meet the standards established by the Food and Drug Administration?

"Our expert team have assigned a safety rating of 2 to the Active group, as there is evidence that suggests it is secure but no data exists which proves its efficacy."

Answered by AI

Are there any available vacancies in this clinical trial for participants?

"According to clinicaltrials.gov, this study is currently seeking participants. The trial was initially announced on June 1st 2021 and the latest information available dates from October 10th 2023."

Answered by AI

How many individuals can participate in this investigation?

"Affirmative. Per the data found on clinicaltrials.gov, this medical study has been actively searching for potential enrollees since June 1st 2021 and it is still ongoing as of October 10th 2023. This trial requires 40 participants to be recruited from a single site."

Answered by AI