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Neuromodulation

Neuromodulation for Depression

N/A
Recruiting
Led By F. Andrew Kozel, M.D., M.S.C.R., D.F.A.P.A.
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Inability to stop taking any medication that significantly increases cortical excitability (e.g., tricyclic antidepressants, stimulants, clozapine, etc.)
Severe Traumatic Brain Injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline over 10 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether two non-invasive therapies, Virtual Reality and Transcranial Magnetic Stimulation, are effective in treating patients with dysphoria, a symptom of unease or dissatisfaction experienced across a range of diagnoses.

Who is the study for?
This trial is for adults over 18 with dysphoria, which can be part of depression or pain conditions. Participants must have stable medication and therapy for a month before the study and not change them during it. They need to be able to consent and follow the study's procedures. Excluded are those at suicide risk, with severe mental disorders like schizophrenia, significant hearing or vision loss, unstable medical conditions, substance abuse issues, non-English speakers, pregnant women, prisoners.
What is being tested?
The trial tests two neuromodulation treatments: Guided Meditation using Virtual Reality (VR) to provide sensory experiences that may ease dysphoria; Accelerated Transcranial Magnetic Stimulation (TMS), where magnetic pulses stimulate brain neurons quickly compared to traditional TMS schedules. The goal is to see if these treatments are effective and practical.
What are the potential side effects?
Potential side effects from VR might include dizziness or nausea due to motion sickness. For accelerated TMS possible side effects could include scalp discomfort at the treatment site during stimulation sessions, headache after treatment sessions or in rare cases seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study details and can follow its requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot stop taking medication that affects my brain's activity.
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I have had a severe brain injury.
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I do not have any brain-related health conditions or devices.
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I do not have dementia or cognitive issues affecting my treatment participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline over 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline over 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Arm 1 Hypothesis 1
Arm 1 Hypothesis 2
Arm 1 Hypothesis 3
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Guided Meditation VR for WellnessActive Control1 Intervention
Selected modules of commercially available meditation VR
Group II: Accelerated Transcranial Magnetic Stimulation: Treatment AActive Control1 Intervention
Intermittent theta-burst over dlPFC
Group III: Accelerated Transcranial Magnetic Stimulation: Treatment BActive Control1 Intervention
Intermittent theta-primed 10Hz over mPFC

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
224 Previous Clinical Trials
36,541 Total Patients Enrolled
8 Trials studying Depression
1,487 Patients Enrolled for Depression
F. Andrew Kozel, M.D., M.S.C.R., D.F.A.P.A.Principal InvestigatorFlorida State University

Media Library

Accelerated Transcranial Magnetic Stimulation: Treatment A (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05061745 — N/A
Depression Research Study Groups: Guided Meditation VR for Wellness, Accelerated Transcranial Magnetic Stimulation: Treatment A, Accelerated Transcranial Magnetic Stimulation: Treatment B
Depression Clinical Trial 2023: Accelerated Transcranial Magnetic Stimulation: Treatment A Highlights & Side Effects. Trial Name: NCT05061745 — N/A
Accelerated Transcranial Magnetic Stimulation: Treatment A (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061745 — N/A
~24 spots leftby Dec 2025
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