Neuromodulation for Dysphoria

  • STATUS
    Recruiting
  • End date
    Aug 10, 2026
  • participants needed
    100
  • sponsor
    Florida State University
Updated on 10 December 2021

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.

Details
Condition Dysphoria
Treatment Guided Meditation VR for Wellness, Accelerated Transcranial Magnetic Stimulation: Treatment A, Accelerated Transcranial Magnetic Stimulation: Treatment B
Clinical Study IdentifierNCT05061745
SponsorFlorida State University
Last Modified on10 December 2021

Eligibility

Yes No Not Sure

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.)
Unstable medical conditions or any current medical condition that could preclude being able to safely participate in this phase of the study (e.g., unstable metabolic abnormality, unstable angina, etc.)
Severe Traumatic Brain Injury
We will exclude non-English speakers because of the need for rapid communication before and during the use of technology
Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation)
The following groups will NOT be included
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Prisoners
Inclusion for Arms 2 and 3
Adults age 18 years and above
Reported symptom of dysphoria: PHQ-9 10; GAD-7 10; PCL-5 45 or Average Pain 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 changes in supportive psychotherapy for 1 month prior to initial 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 for Arms 2 and 3
Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
Active substance use disorder 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 lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
Current, planned, or suspected pregnancy
Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)
Severe Traumatic Brain Injury
We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments
Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation)
The following groups will NOT be included
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note