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ACTIVE NOT RECRUITING
NCT07812987
NA

Rapid Entrainment and Signal-guided Neuromodulation for Behavioral Health

Sponsor: Tactical Mind Research Coalition, Inc.

View on ClinicalTrials.gov

Summary

RESYNC-BH is a research study evaluating a personalized, non-drug brain-and-body treatment approach for adults with ongoing behavioral health symptoms such as depression, anxiety, trauma-related symptoms, sleep problems, attention difficulties, or substance-use concerns. Rather than assigning treatment solely according to psychiatric diagnosis, treatment approaches are selected based on symptoms, physiologic measures, and clinical presentation. Treatment may include noninvasive neuromodulation, sensory stimulation, regulated breathing, and AIP-informed integrative psychotherapy. The study will evaluate whether personalized treatment approaches produce rapid and sustained improvements in behavioral health symptoms and functioning, and whether treatment response is accompanied by measurable changes in neurophysiologic, autonomic, cognitive, inflammatory, and behavioral measures. The study hypothesis is that meaningful clinical improvement is associated with measurable changes across brain, body, cognitive, and behavioral signals, and that early changes in these measures may help characterize treatment response and its durability. The long-term goal is to develop more objective and personalized methods for monitoring behavioral health treatment response.

Official title: Rapid Entrainment and Signal-guided Neuromodulation for Behavioral Health: A Transdiagnostic, Personalized Neuromodulation and Neuroimmune Study to Develop Objective Endpoints and Risk/Durability Profiles for Rapid-Acting Interventions (RESYNC-BH)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-08-01

Completion Date

2028-12-31

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

BEHAVIORAL

AIP-Informed Integrative Psychotherapy

A structured psychotherapy approach based on the Adaptive Information Processing (AIP) model, incorporating EMDR-informed techniques and other evidence-based psychotherapeutic strategies as clinically appropriate. The intervention is delivered as part of PRESET-Rx sessions to support processing and integration.

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

Noninvasive transcutaneous auricular vagus nerve stimulation delivered through cutaneous ear electrodes according to prespecified protocol and safety parameters.

BEHAVIORAL

Regulated Breathing and Autonomic Regulation

Structured breathing and related autonomic-regulation practices delivered according to prespecified protocol procedures.

DEVICE

Audiovisual Entrainment

Noninvasive patterned visual and auditory stimulation delivered according to prespecified protocol procedures as part of PRESET-Rx sessions.

DEVICE

Vibroacoustic Stimulation

Noninvasive mechanical vibration delivered through a vibroacoustic surface according to prespecified protocol procedures. This intervention may be used selectively based on protocol-defined clinical and safety considerations.

BEHAVIORAL

Breathwork-Based Auditory Driving Entropy Module (BADEM)

A structured, time-limited breathwork and auditory stimulation procedure that may be used selectively according to prespecified protocol and safety criteria.

DEVICE

Transcranial Electrical Stimulation

Noninvasive low-intensity transcranial electrical stimulation delivered through scalp electrodes according to prespecified protocol and safety parameters.

Locations (1)

Tactical Mind Research Coalition

Tampa, Florida, United States