Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring
NCT01192685 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2017-04-20
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.
Conditions
Interventions
- PROCEDURE
-
Transcranial Magnetic Stimulation (TMS)
TMS will be administered to subjects 5 days a week-typically Monday through Friday, for 6 weeks.
- DEVICE
-
near infrared spectroscopy (NIRS)
near infrared spectroscopy (NIRS) will be used to measure the blood flow in the brain
Sponsors & Collaborators
-
Boston Medical Center
collaborator OTHER -
Boston University
lead OTHER
Principal Investigators
-
Ofra Sarid-Segal, MD · Boston University
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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