Florida State University
Tallahassee, Florida, 32306, United States
NCT Number: NCT05061745
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tallahassee, Florida, 32306, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Arm 1:
Exclusion criteria
for Arm 1:
Inclusion for Arms 2 and 3:
Exclusion for Arms 2 and 3 :
Selected Modules of Commercially Available "Guided Meditation VR" presented on Valve Index Headset
MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)
Other names: Treatment A
MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)
Other names: Treatment B
Time frame: Week 2
Primary Outcome will be determined by descriptive feasibility metrics. Feasibility will be determined by number of patients enrolled.
Time frame: Week 2
Primary Outcome measure is SF-36 Short Form for all patients.
Time frame: Week 2
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Time frame: From Baseline over 10 weeks
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Time frame: Week 2
Primary Outcome measure is the SF-36 Short Form for all participants.
Time frame: Week 2
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Time frame: From Baseline to Week 6
Primary Outcome measure is SF-36 Short Form for all participants.
Time frame: Week 2
Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
Time frame: Treatment B-Week 6
Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
Time frame: 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).
Florida State University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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