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NCT05061745
NA

Neuromodulation for Dysphoria

Sponsor: Florida State University

View on ClinicalTrials.gov

Summary

This is an open label prospective pilot study of two neuromodulation interventions for patients suffering from dysphoria. Dysphoria is a transdiagnostic symptom of unease or dissatisfaction experienced across a range of diagnoses, including mood disorders and pain. There is a significant gap of treatment options across conditions with dysphoria, particularly non-medicated and self-care alternatives. Many neuromodulation therapies require extensive medical resources or time to deliver. Thus, the investigators will test two non-invasive technologies administered in a manner that would reduce resources and/or time. Virtual Reality (VR) overlays the sensory system to block the external environment and provide vast range of meaningful sensory experiences. Transcranial Magnetic Stimulation (TMS) involves a magnetic pulse passing through the scalp to depolarize neurons in the outer cortex of the brain, and daily treatments over 6 weeks are currently FDA indicated for the treatment of major depressive disorder. Accelerated TMS is the delivery of treatment in a shorter period of time. The primary objective of this study to demonstrate the preliminary effectiveness, tolerability, and feasibility of these two interventions: Guided Meditation VR for Wellness and Accelerated Transcranial Magnetic Stimulation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2021-09-29

Completion Date

2025-11-14

Last Updated

2026-04-13

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Guided Meditation VR for Wellness

Selected Modules of Commercially Available "Guided Meditation VR" presented on Valve Index Headset

DEVICE

Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)

MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)

DEVICE

Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)

MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)

Locations (1)

Florida State University

Tallahassee, Florida, United States