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Apply tACS to Alleviate Anxiety Symptoms

Primary Purpose

Anxiety Disorders

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
transcranial alternating current stimulation (tACS)
Sponsored by
NeuroCognitive and Behavioral Institute Clinical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

  • NCI Clinical Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active group

Sham group

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2023
Last Updated
October 16, 2023
Sponsor
NeuroCognitive and Behavioral Institute Clinical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT06086015
Brief Title
Apply tACS to Alleviate Anxiety Symptoms
Official Title
Non-invasive Neuromodulation of the Right Anterior Amygdala Using tACS: A Double-blind Randomized Sham Controlled Clinical Trial for the Treatment of Anxiety Related Disorders With an Open-Label Extension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroCognitive and Behavioral Institute Clinical Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active group
Arm Type
Experimental
Arm Title
Sham group
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
transcranial alternating current stimulation (tACS)
Intervention Description
2mA tACS over right hemisphere, at positions F4, P4, T8 (10-10 convention)
Primary Outcome Measure Information:
Title
Response rate informed by Beck Anxiety Inventory (BAI)
Description
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.
Title
Hamilton Anxiety Rating Scale (HAMA)
Description
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 Outcome Measure Information:
Title
PTSD Checklist (PCL) for PTSD cohort
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald Tramontano, PhD
Phone
9736010100
Email
gtramontano@neuroci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Tramontano
Organizational Affiliation
NCI Clinical Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
NCI Clinical Research Foundation
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Tramontano, PhD
Phone
973-601-0100
Email
gtramontano@neuroci.com
First Name & Middle Initial & Last Name & Degree
Chen Lee, PhD
Phone
8623919993
Email
tl@neuroci.com

12. IPD Sharing Statement

Plan to Share IPD
No

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