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NCT02611206 · ClinicalTrials.gov registry record · NA
Repetitive Transcranial Magnetic Stimulation for Adolescent Depression: Efficacy, Predictive Biomarkers, and Mechanisms
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT02611206 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 24 participants.
The verdict
NCT02611206, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will be an open-label 6-week (30 session) trial of active repetitive transcranial magnetic stimulation (rTMS) using a fixed frequency (10 Hz) but varying stimulation intensities using a 3+3 study design for safety and tolerability amongst adolescents. This means that we will only enroll 3 participants at a time and give them rTMS at the stimulation intensity energy of 80% of motor threshold (MT). If all three participants complete the 6 weeks of treatment with no major safety events (i.e. seizure), we will increase the energy for the next 3 participants by 20%. If 1 of the 3 participants has a major safety event, we will enroll 3 more patients at the SAME energy. We will proceed in this manner, increasing by 20% after 3 subjects safely complete treatment at that energy, to a maximum energy of 120% of motor threshold. If 2 participants in each intensity level cohort experience a major safety event, we will discontinue running subjects at that energy level. If this happens at our initial energy level of 80% of MT, we will stop the study. If we reach 2 events in any of the higher energy cohorts, we will return to the previous energy level and complete the remainder of the subjects at that energy level.
Interventions
- DEVICE Active Repetitive Transcranial Magnetic Stimulation (rTMS): intensity 80% MT
- DEVICE Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS); Stimulation intesity: 100% of MT
- DEVICE Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS); Stimulation intesity: 120% of MT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-10 |
| Est. Completion | 2021-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02611206
The ClinicalTrials.gov registry entry for NCT02611206 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Active Repetitive Transcranial Magnetic Stimulation (rTMS): intensity 80% MT is the first listed.
NCT02611206 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02611206 about?
NCT02611206 is a clinical study titled "Repetitive Transcranial Magnetic Stimulation for Adolescent Depression: Efficacy, Predictive Biomarkers, and Mechanisms". This study will be an open-label 6-week (30 session) trial of active repetitive transcranial magnetic stimulation (rTMS) using a fixed frequency (10 Hz) but varying stimulation intensities using a 3+3 study design for safety and tolerability amongst adolescents. This means that we will only enroll 3...
What is the current status of trial NCT02611206?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2015-10. Estimated completion is 2021-12-01.
What interventions are being tested in trial NCT02611206?
The interventions under investigation include: Active Repetitive Transcranial Magnetic Stimulation (rTMS): intensity 80% MT (DEVICE), Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS); Stimulation intesity: 100% of MT (DEVICE), Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS); Stimulation intesity: 120% of MT (DEVICE).
Who is sponsoring clinical trial NCT02611206?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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