Neuromodulation for Dysphoria

April 7, 2026 updated by: F. Andrew Kozel, Florida State University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Florida State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for Arm 1:

  1. Adults age 18 years and above
  2. 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
  3. 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.
  4. 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 for Arm 1:

  1. Significant auditory or visual impairment that prevents participants from using Virtual Reality headset.
  2. Neurologic conditions or devices impacting brain circuitry (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
  3. 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
  4. Dementia or other cognitive disorder making unable to engage in treatment
  5. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.
  6. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
  7. OCD cannot be the primary disorder but can have OCD symptoms
  8. Inability to stop taking any medication that significantly increases cortical excitability (e.g., tricyclic antidepressants, stimulants, clozapine, etc.)
  9. 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.)
  10. Severe Traumatic Brain Injury
  11. We will exclude non-English speakers because of the need for rapid communication before and during the use of technology.
  12. 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).

  13. 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:

  1. Adults age 18 years and above
  2. 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
  3. 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
  4. 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 :

  1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
  2. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
  3. Dementia or other cognitive disorder making unable to engage in treatment
  4. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, delusional Disorder or other psychotic illness that precludes safe participation in trial
  5. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide
  6. OCD cannot be the primary disorder but can have OCD symptoms
  7. Inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
  8. Current, planned, or suspected pregnancy
  9. 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.)
  10. Severe Traumatic Brain Injury
  11. We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments
  12. 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).

  13. The following groups will NOT be included.

    • Adults unable to consent
    • Individuals who are not yet adults (infants, children, teenagers)
    • Pregnant women
    • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Guided Meditation VR for Wellness
Selected modules of commercially available meditation VR
Device: Guided Meditation VR for Wellness
Selected Modules of Commercially Available "Guided Meditation VR" presented on Valve Index Headset
Active Comparator: Accelerated Transcranial Magnetic Stimulation: Treatment A
Intermittent theta-burst over dlPFC
Device: Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)
MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)
Other Names:
  • Treatment A
Active Comparator: Accelerated Transcranial Magnetic Stimulation: Treatment B
Intermittent theta-primed 10Hz over mPFC
Device: Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)
MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)
Other Names:
  • Treatment B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm 1 Hypothesis 1
Time Frame: Week 2
Primary Outcome will be determined by descriptive feasibility metrics. Feasibility will be determined by number of patients enrolled.
Week 2
Arm 1 Hypothesis 2
Time Frame: Week 2
Primary Outcome measure is SF-36 Short Form for all patients.
Week 2
Arm 1 Hypothesis 3
Time Frame: Week 2
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Week 2
Arm 1 Hypothesis 4
Time Frame: From Baseline over 10 weeks
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
From Baseline over 10 weeks
Arm 2 Hypothesis 1
Time Frame: Week 2
Primary Outcome measure is the SF-36 Short Form for all participants.
Week 2
Arm 2 Hypothesis 2
Time Frame: Week 2
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Week 2
Arm 2-3 Hypothesis 3
Time Frame: From Baseline to Week 6
Primary Outcome measure is SF-36 Short Form for all participants.
From Baseline to Week 6
Arm 2-3 Hypothesis 4
Time Frame: Week 2
Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
Week 2
Arm 2-3 Hypothesis 4-Treatment B
Time Frame: Treatment B-Week 6
Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
Treatment B-Week 6
Arm 3 Hypothesis 5
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).
Treatment B - Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Investigators

  • Principal Investigator: F. Andrew Kozel, M.D., M.S.C.R., D.F.A.P.A., Florida State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Actual)

November 14, 2025

Study Completion (Actual)

November 14, 2025

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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