tACS for Anxiety Disorders

Overseen By Gerald Tramontano, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: NeuroCognitive and Behavioral Institute Clinical Research Foundation

Disqualifiers: Neurodegenerative, Epilepsy, Pregnancy, Schizophrenia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 3-4 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gerald Tramontano

Principal Investigator

NCI Clinical Research Foundation

Eligibility Criteria

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.

Inclusion Criteria

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

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

I started psychotherapy at least 2 months before joining the study.

Exclusion Criteria

Pregnancy or lactation

Cardiac pacemakers or other implanted biomedical devices

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 25 minutes of 5 Hz transcranial alternating current stimulation (tACS) titrated up to 2mA targeting the anterolateral amygdala across 12 treatment sessions

3-4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Treatment Details

Interventions

• transcranial alternating current stimulation (tACS)

Trial Overview 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.

Participant Groups

Group I: Active group Experimental Treatment 1 Intervention

Group II: Sham group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

NeuroCognitive and Behavioral Institute Clinical Research Foundation

Lead Sponsor

Trials

1

Recruited

40+