Anxiety DisordersPhase 2NCT06086015
Apply tACS to Alleviate Anxiety Symptoms
A Phase 2 study testing transcranial alternating current stimulation (tACS) in people with Anxiety Disorders, run by NeuroCognitive and Behavioral Institute Clinical Research Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- transcranial alternating current stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Neurodegenerative disease
- Epilepsy
- Intellectual Disability
- Pregnancy or lactation
- Convexity skull defects
- Raised intracranial pressure
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NCI Clinical Research Foundation
Mount Arlington, New Jersey, 07856
Gerald Tramontano, PhD, 973-601-0100, gtramontano@neuroci.com
Chen Lee, PhD, 8623919993, tl@neuroci.com
About this study
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
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.
- Conditions
- Anxiety Disorders
- Being tested
- transcranial alternating current stimulation (tACS)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial alternating current stimulation (tACS)Device
2mA tACS over right hemisphere, at positions F4, P4, T8 (10-10 convention)
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Not described Receives: Device: transcranial alternating current stimulation (tACS) |
| Sham group | Placebo comparator | Not described Receives: Device: transcranial alternating current stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
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.
Measured: 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
Measured: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Jun 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroCognitive and Behavioral Institute Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Tramontano, Principal investigator, NCI Clinical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086015
- Sponsor's protocol ID
- AMG-05
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06086015
- Acronym / sponsor ID
- AMG-05
- Conditions
- Anxiety Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NeuroCognitive and Behavioral Institute Clinical Research FoundationUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Device: transcranial alternating current stimulation (tACS) |
| Sham group | Placebo comparator | Device: transcranial alternating current stimulation (tACS) |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- Neurodegenerative disease
- Epilepsy
- Intellectual Disability
- Pregnancy or lactation
- Convexity skull defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial alternating current stimulation (tACS)2mA tACS over right hemisphere, at positions F4, P4, T8 (10-10 convention) | Device | Active group, Sham group |
Primary outcome
Response rate informed by Beck Anxiety Inventory (BAI)
Time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
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)
Time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
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.
1 secondary outcome
PTSD Checklist (PCL) for PTSD cohort
Time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Tramontano principal investigator
NCI Clinical Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transcranial alternating current stimulation (tACS) in people with Anxiety Disorders, run by NeuroCognitive and Behavioral Institute Clinical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerald Tramontano, PhD (9736010100, gtramontano@neuroci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate informed by Beck Anxiety Inventory (BAI) (time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.