NCT06086015

Apply tACS to Alleviate Anxiety Symptoms

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NeuroCognitive and Behavioral Institute Clinical Research Foundation · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	transcranial alternating current stimulation (tACS)	2mA tACS over right hemisphere, at positions F4, P4, T8 (10-10 convention)

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2023-10-17
• Last updated: 2023-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study