Neuromodulation for Dysphoria

Not Applicable

Recruiting

• Conditions: Dysphoria
• Interventions: Device: Guided Meditation VR for Wellness

• Registration Number: NCT05061745
• Lead Sponsor: Florida State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-09-27
• Study Start: 2021-09-29
• Study First Posted: 2021-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Guided Meditation VR for Wellness	Guided Meditation VR for Wellness	Selected modules of commercially available meditation VR

Primary Outcome Measures

Name	Time	Method
Arm 1 Hypothesis 2	Week 2	Primary Outcome measure is SF-36 Short Form for all patients.
Arm 1 Hypothesis 1	Week 2	Primary Outcome will be determined by descriptive feasibility metrics. Feasibility will be determined by number of patients enrolled.
Arm 1 Hypothesis 4	From Baseline over 10 weeks	Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Arm 3 Hypothesis 5	Treatment B - Week 2	Primary Outcome measure is the SF-36 Short Form for all participants. Significantly greater improvement in rating scores from baseline of Treatment A Exit Visit ("Follow Up A1" or "Follow Up A5") to "Follow Up B1" will be tested (t-test).
Arm 1 Hypothesis 3	Week 2	Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Arm 2 Hypothesis 1	Week 2	Primary Outcome measure is the SF-36 Short Form for all participants.
Arm 2 Hypothesis 2	Week 2	Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Arm 2-3 Hypothesis 3	From Baseline to Week 6	Primary Outcome measure is SF-36 Short Form for all participants.
Arm 2-3 Hypothesis 4	Week 2	Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
Arm 2-3 Hypothesis 4-Treatment B	Treatment B-Week 6	Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States