DysphoriaNCT05061745
Neuromodulation for Dysphoria
A study testing Guided Meditation VR for Wellness, Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP) and Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP) in people with Dysphoria, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphoria
- What is being tested?
- Guided Meditation VR for Wellness, Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP) and Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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.
Show all 33Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
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.
- Conditions
- Dysphoria
- Being tested
- Guided Meditation VR for Wellness, Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP), Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)
- Keywords
- Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Meditation VR for WellnessDevice
Selected Modules of Commercially Available "Guided Meditation VR" presented on Valve Index Headset
Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)Device
Also called Treatment A
MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)
Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)Device
Also called Treatment B
MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)
| Study group | Role | What they receive |
|---|---|---|
| Guided Meditation VR for Wellness | Active comparator | Selected modules of commercially available meditation VR Receives: Device: Guided Meditation VR for Wellness |
| Accelerated Transcranial Magnetic Stimulation: Treatment A | Active comparator | Intermittent theta-burst over dlPFC Receives: Device: Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP) |
| Accelerated Transcranial Magnetic Stimulation: Treatment B | Active comparator | Intermittent theta-primed 10Hz over mPFC Receives: Device: Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm 1 Hypothesis 1
Primary Outcome will be determined by descriptive feasibility metrics. Feasibility will be determined by number of patients enrolled.
Measured: Week 2
Arm 1 Hypothesis 2
Primary Outcome measure is SF-36 Short Form for all patients.
Measured: Week 2
Arm 1 Hypothesis 3
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Measured: Week 2
Arm 1 Hypothesis 4
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Measured: From Baseline over 10 weeks
Arm 2 Hypothesis 1
Primary Outcome measure is the SF-36 Short Form for all participants.
Measured: Week 2
Arm 2 Hypothesis 2
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Measured: Week 2
Arm 2-3 Hypothesis 3
Primary Outcome measure is SF-36 Short Form for all participants.
Measured: From Baseline to Week 6
Arm 2-3 Hypothesis 4
Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
Measured: Week 2
Arm 2-3 Hypothesis 4-Treatment B
Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
Measured: 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).
Measured: Treatment B - Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start29 Sep 2021
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DysphoriaStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F. Andrew Kozel, Florida State University
- Investigators
- F. Andrew Kozel, M.D., M.S.C.R., D.F.A.P.A., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061745
- Sponsor's protocol ID
- STUDY00002372
- Status last verified
- Apr 2026
- First submitted
- 30 Aug 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Senda MC, Johnson KA, Taylor IM, Jensen MM, Hou Y, Kozel FA. A Pilot Trial of Stepwise Implementation of Virtual Reality Mindfulness and Accelerated Transcranial Magnetic Stimulation Treatments for Dysphoria in Neuropsychiatric Disorders. Depress Anxiety. 2023 Nov 22;2023:9025984. doi: 10.1155/2023/9025984. eCollection 2023.
PubMed 40224597Spitz AM, Senda MC, Johnson KA, Taylor IM, Jensen MM, Kozel FA. The Relationship of Anxious Arousal With Treatment of Dysphoria Using Virtual Reality Mindfulness and 2 Accelerated Transcranial Magnetic Stimulation Protocols. J Clin Psychiatry. 2024 May 22;85(2):23m15195. doi: 10.4088/JCP.23m15195.
PubMed 38780528
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation for Dysphoria
- ClinicalTrials.gov ID
- NCT05061745
- Acronym / sponsor ID
- STUDY00002372
- Conditions
- Dysphoria
- Keywords
- Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Meditation VR for Wellness | Active comparator | Device: Guided Meditation VR for WellnessSelected modules of commercially available meditation VR |
| Accelerated Transcranial Magnetic Stimulation: Treatment A | Active comparator | Device: Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)Intermittent theta-burst over dlPFC |
| Accelerated Transcranial Magnetic Stimulation: Treatment B | Active comparator | Device: Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)Intermittent theta-primed 10Hz over mPFC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Adults age 18 years and above
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Meditation VR for WellnessSelected Modules of Commercially Available "Guided Meditation VR" presented on Valve Index Headset | Device | Guided Meditation VR for Wellness |
| Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)Also: Treatment AMagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP) | Device | Accelerated Transcranial Magnetic Stimulation: Treatment A |
| Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)Also: Treatment BMagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP) | Device | Accelerated Transcranial Magnetic Stimulation: Treatment B |
Primary outcome
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.
Arm 1 Hypothesis 2
Time frame: Week 2
Primary Outcome measure is SF-36 Short Form for all patients.
Arm 1 Hypothesis 3
Time frame: Week 2
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
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.
Arm 2 Hypothesis 1
Time frame: Week 2
Primary Outcome measure is the SF-36 Short Form for all participants.
Arm 2 Hypothesis 2
Time frame: Week 2
Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.
Arm 2-3 Hypothesis 3
Time frame: From Baseline to Week 6
Primary Outcome measure is SF-36 Short Form for all participants.
Arm 2-3 Hypothesis 4
Time frame: Week 2
Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 40224597Senda MC, Johnson KA, Taylor IM, Jensen MM, Hou Y, Kozel FA. A Pilot Trial of Stepwise Implementation of Virtual Reality Mindfulness and Accelerated Transcranial Magnetic Stimulation Treatments for Dysphoria in Neuropsychiatric Disorders. Depress Anxiety. 2023 Nov 22;2023:9025984. doi: 10.1155/2023/9025984. eCollection 2023.
- Derived from this study: PubMed 38780528Spitz AM, Senda MC, Johnson KA, Taylor IM, Jensen MM, Kozel FA. The Relationship of Anxious Arousal With Treatment of Dysphoria Using Virtual Reality Mindfulness and 2 Accelerated Transcranial Magnetic Stimulation Protocols. J Clin Psychiatry. 2024 May 22;85(2):23m15195. doi: 10.4088/JCP.23m15195.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F. Andrew Kozel, M.D., M.S.C.R., D.F.A.P.A. principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Meditation VR for Wellness, Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP) and Accelerated Transcranial Magnetic Stimulation: MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP) in people with Dysphoria, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm 1 Hypothesis 1 (time frame: Week 2). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05061745, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.