Apply tACS to Alleviate Anxiety Symptoms

NCT06086015 | Unknown Phase 2 DMC FDA Device

• 1 other identifier: AMG-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

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

Study Arms (2)

Active group

EXPERIMENTAL

Device: transcranial alternating current stimulation (tACS)

Sham group

PLACEBO COMPARATOR

Device: transcranial alternating current stimulation (tACS)

Interventions

transcranial alternating current stimulation (tACS) DEVICE

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

Active group; Sham group

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NeuroCognitive and Behavioral Institute Clinical Research Foundation: lead

Study Sites (1)

NCI Clinical Research Foundation

Mount Arlington, New Jersey, 07856, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Gerald Tramontano

  NCI Clinical Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald Tramontano, PhD

CONTACT

9736010100; gtramontano@neuroci.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 17, 2023
• Study Start: June 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)