NCT05061745

Neuromodulation for Dysphoria

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphoria

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-09-29
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2021-09-30
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study