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NCT05061745 · ClinicalTrials.gov registry record · NA
Neuromodulation for Dysphoria
A NA study of Dysphoria, sponsored by Florida State University.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05061745: Recruiting NA study of Dysphoria, sponsored by Florida State University.
NCT05061745 is a NA study of Dysphoria that is actively recruiting participants, run by Florida State University. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05061745, a NA study of Dysphoria, is actively recruiting participants, sponsored by Florida State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Primary Outcome will be determined by descriptive feasibility metrics. Feasibility will be determined by number of patients enrolled.
Conditions Studied
Interventions
- DEVICE Guided Meditation VR for Wellness
- DEVICE Accelerated Transcranial Magnetic Stimulation: Treatment A
- DEVICE Accelerated Transcranial Magnetic Stimulation: Treatment B
Study Locations (1)
Florida
- Florida State University - Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2027-08 |
| Phase | NA |
What NCT05061745 shows while recruiting
NCT05061745 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Dysphoria appearing as the primary indexed condition, and to 3 interventions - of which Guided Meditation VR for Wellness is the first listed.
NCT05061745 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05061745 about?
NCT05061745 is a clinical study titled "Neuromodulation for Dysphoria". 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 trea...
What is the current status of trial NCT05061745?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-09-29. Estimated completion is 2027-08.
What conditions does trial NCT05061745 study?
This clinical trial studies the following conditions: Dysphoria.
What interventions are being tested in trial NCT05061745?
The interventions under investigation include: Guided Meditation VR for Wellness (DEVICE), Accelerated Transcranial Magnetic Stimulation: Treatment A (DEVICE), Accelerated Transcranial Magnetic Stimulation: Treatment B (DEVICE).
Who is sponsoring clinical trial NCT05061745?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05061745 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05061745's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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