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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Arm 1 Hypothesis 1

Timeframe: Week 2

Arm 1 Hypothesis 2

Timeframe: Week 2

Arm 1 Hypothesis 3

Timeframe: Week 2

Arm 1 Hypothesis 4

Timeframe: From Baseline over 10 weeks

Arm 2 Hypothesis 1

Timeframe: Week 2

Arm 2 Hypothesis 2

Timeframe: Week 2

Arm 2-3 Hypothesis 3

Timeframe: From Baseline to Week 6

Arm 2-3 Hypothesis 4

Timeframe: Week 2

Trial details

NCT IDNCT05061745

SponsorFlorida State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-14

View on ClinicalTrials.gov More Dysphoria trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Arm 1 Hypothesis 1

Timeframe: Week 2

Arm 1 Hypothesis 2

Timeframe: Week 2

Arm 1 Hypothesis 3

Timeframe: Week 2

Arm 1 Hypothesis 4

Timeframe: From Baseline over 10 weeks

Arm 2 Hypothesis 1

Timeframe: Week 2

Arm 2 Hypothesis 2

Timeframe: Week 2

Arm 2-3 Hypothesis 3

Timeframe: From Baseline to Week 6

Arm 2-3 Hypothesis 4

Timeframe: Week 2