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NCT06003309 · ClinicalTrials.gov registry record · NA
Frequency and E-field Enhancement of ITBS for Depression (FREED)
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT06003309 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 75 participants.
The verdict
NCT06003309, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study Summary
The investigators propose a randomized 3-arm double-blinded parallel experimental trial (20 sessions over 4 weeks) in 75 patients with TRD. The three arms include (1) the combination of a fully Individualized form of intermittent Theta Burst Stimulation (iTBS) (using BOTH the frequency and electric field (E-field) targeting approaches) (Ind-iTBS)), (2) iTBS individualized using E-field targeting only (targeted-iTBS) and (3) Standard iTBS treatment (i.e., typical iTBS localized to the dorsolateral prefrontal cortex (DLPFC) using the Beam F3 method). Electroencephalography (EEG) data will be collected at rest and during a working memory task, at baseline, and at the end of treatment along with clinical assessments of depression severity. The target engagement dependent variable of interest in these three arms will be fronto-parietal theta connectivity measured through resting-state EEG. The investigators hypothesize that stimulation with Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity than that produced with targeted-TBS and standard iTBS. Aim: To evaluate the effects of two individualized forms of iTBS (i.e., using BOTH the frequency and E-field individualization; Ind-iTBS) compared to iTBS individualized for E-field targeting only (targeted-iTBS) and standard iTBS on fronto-parietal theta connectivity. Hypotheses: (1) Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity compared to both targeted-iTBS and standard iTBS. (2) Ind-iTBS will also lead to a greater reduction in depressive symptoms (as defined by the mean reduction in Montgomery Åsberg Depression Rating Scale Scores (MADRS)) compared to both targeted-iTBS and standard iTBS.
Interventions
- DEVICE Transcranial Magnetic Stimulation (TMS) - Fully Individualized iTBS
- DEVICE Transcranial Magnetic Stimulation (TMS) - targeted-iTBS
- DEVICE Transcranial Magnetic Stimulation (TMS) - Standard-iTBS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2025-12-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06003309
The ClinicalTrials.gov registry entry for NCT06003309 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Transcranial Magnetic Stimulation (TMS) - Fully Individualized iTBS is the first listed.
NCT06003309 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06003309 about?
NCT06003309 is a clinical study titled "Frequency and E-field Enhancement of ITBS for Depression (FREED)". The investigators propose a randomized 3-arm double-blinded parallel experimental trial (20 sessions over 4 weeks) in 75 patients with TRD. The three arms include (1) the combination of a fully Individualized form of intermittent Theta Burst Stimulation (iTBS) (using BOTH the frequency and electric ...
What is the current status of trial NCT06003309?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2023-08-31. Estimated completion is 2025-12-30.
What interventions are being tested in trial NCT06003309?
The interventions under investigation include: Transcranial Magnetic Stimulation (TMS) - Fully Individualized iTBS (DEVICE), Transcranial Magnetic Stimulation (TMS) - targeted-iTBS (DEVICE), Transcranial Magnetic Stimulation (TMS) - Standard-iTBS (DEVICE).
Who is sponsoring clinical trial NCT06003309?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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