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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Selected Modules of Commercially Available "Guided Meditation VR" presented on Valve Index Headset
MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)
MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)
Florida State University
Tallahassee, Florida, United States
Arm 1 Hypothesis 1
Primary Outcome will be determined by descriptive feasibility metrics. Feasibility will be determined by number of patients enrolled.
Time frame: Week 2
Arm 1 Hypothesis 2
Primary Outcome measure is SF-36 Short Form for all patients.
Time frame: Week 2
Arm 1 Hypothesis 3
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Time frame: Week 2
Arm 1 Hypothesis 4
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Time frame: From Baseline over 10 weeks
Arm 2 Hypothesis 1
Primary Outcome measure is the SF-36 Short Form for all participants.
Time frame: Week 2
Arm 2 Hypothesis 2
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Time frame: Week 2
Arm 2-3 Hypothesis 3
Primary Outcome measure is SF-36 Short Form for all participants.
Time frame: From Baseline to Week 6
Arm 2-3 Hypothesis 4
Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
Time frame: Week 2
Arm 2-3 Hypothesis 4-Treatment B
Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
Time frame: Treatment B-Week 6
Arm 3 Hypothesis 5
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).
Time frame: Treatment B - Week 2
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