Neuromodulation for Dysphoria (NCT05061745) | Clinical Trial Compass
CompletedNot Applicable
Neuromodulation for Dysphoria
United States29 participantsStarted 2021-09-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults age 18 years and above
✓. Reported symptoms of dysphoria: PHQ-9 ≥ 10; GAD-7 ≥ 10; PCL-5 ≥ 45 or Average Pain Intensity ≥ 4/10 for \> 3 months - this will ensure at least moderate level of reported difficulty with mood, anxiety, trauma, or pain
✓. No changes in psychotropic medication (if taking psychotropic medication) and/or supportive psychotherapy for 1 month prior to baseline visit; and clinically appropriate to maintain stable treatment regimen for duration of trial.
✓. Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study
Exclusion criteria
✕. Significant auditory or visual impairment that prevents participants from using Virtual Reality headset.
✕. Neurologic conditions or devices impacting brain circuitry (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
✕. Active substance use disorder or hallucinogen use in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
✕. Dementia or other cognitive disorder making unable to engage in treatment
✕. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.
✕. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
✕. OCD cannot be the primary disorder but can have OCD symptoms
✕. Inability to stop taking any medication that significantly increases cortical excitability (e.g., tricyclic antidepressants, stimulants, clozapine, etc.)