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NCT01192685 · ClinicalTrials.gov registry record · Early Phase 1
Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring
A Early Phase 1 study, sponsored by Boston University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT01192685: Clinical Trial Early Phase 1 study, sponsored by Boston University.
NCT01192685 is a Early Phase 1 study that was terminated before completion, run by Boston University. The registered enrollment target is 2 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192685, a Early Phase 1 study, was terminated before completion, sponsored by Boston University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this trial, up to fifty subjects will be consented. The primary purpose of the current study is to determine: 1) if changes in electrical activity of the brain measured by EEG in specific areas is associated with changes in the blood flow of the brain 2) Which areas of the brain show changes in electrical activity and treatment response.
Primary Outcome
The primary outcome will be the correlations between EEG cordance or task-induced changes in frontal total Hb levels and changes in MADRAS scores between baseline and the last treatment day. Correlations between these measures will be determined between other cordance and total Hb levels obtained after the first week of treatment and MADRAS changes for the last day of treatment. Similar analyses will be conducted for changes in MADRAS scores between baseline and the follow-up visit.
Interventions
- PROCEDURE Transcranial Magnetic Stimulation (TMS)
- DEVICE near infrared spectroscopy (NIRS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-12 |
| Phase | Early Phase 1 |
Why NCT01192685 stopped before completion
NCT01192685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Transcranial Magnetic Stimulation (TMS) is the first listed.
NCT01192685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01192685 about?
NCT01192685 is a clinical study titled "Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring". This a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this trial, up to fifty subject...
What is the current status of trial NCT01192685?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2012-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01192685?
The interventions under investigation include: Transcranial Magnetic Stimulation (TMS) (PROCEDURE), near infrared spectroscopy (NIRS) (DEVICE).
Who is sponsoring clinical trial NCT01192685?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01192685's enrollment target sits among peer trials
2 1973rd of 2000 higher than 16 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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