Clinical trial NCT01192685: Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring
Official title: Transcranial Magnetic Stimulation in Major Depression With EEG and NIRS Monitoring
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Depression
Keywords: Depression
Depressed
TMS
Transcranial Magnetic Stimulation
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
First posted: 2010-09-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed description: Transcranial magnetic stimulation (TMS) has demonstrated efficacy as a treatment for major depression. No objective markers have been identified that indicate which patients are most likely to respond to TMS therapy. The goal of the present investigation is to determine whether an electroencephalographic measure called cordance or a measure of blood flow in the frontal brain, as measured by near infrared spectroscopy (NIRS) can serve as predictors of outcome with TMS therapy in depression. Subjects with depression will be treated in this study for 6 weeks with TMS. Frontal brain blood flow measured using NIRS will be assessed prior to TMS therapy, and repeatedly thereafter. EEG cordance will also be obtained following a similar schedule. Measures of depression and other psychiatric disorders will be collected prior to, during and for 2 weeks after the completion of TMS treatment. The correlation between these measures and the EEG and NIRS measures will then be determined to see if these latter measures are predictive of improvement in depression.

Eligibility criteria: Inclusion criteria List

1. Depressive disorder Diagnostic Statistical Manual of Mental Disorders, fourth Edition, Text Revision (DSM-IV-TR).
2. MADRAS score of 26 or above and history of depression, as defined by meeting DSM-IV criteria for major depression, dysthymic disorder, or substance-induced mood disorder.
3. Male or female aged 18 to 65.
4. Females who are not pregnant or nursing.
5. Individuals able to provide informed written consent and are able to comply with study procedures.
6. Subjects who have received or are receiving anti-depressant medication.
7. Patients who are depressed as assessed by the above criteria and have not had optimum response to their antidepressant medication in their current episode.

Exclusion criteria List

1. Any Axis I diagnosis that, in the opinion of the investigators, may interfere with the course of the trial.
2. Any current diagnoses of alcohol abuse or dependence.
3. Any current substance use disorder.
4. Medical or neurological illness that in the investigators judgment would make study compliance difficult or would be a contraindication for use with TMS.
5. Currently receiving any medication that markedly increases the risks for seizures, for example: tricyclic antidepressants, INH, meperidine, lidocaine, and clozapine.
6. Subjects who have implanted metallic devices or non-removable metallic objects in or around the head that can be magnetized, however metal fillings, braces, and dental implants are acceptable.
7. Subjects who have implanted devices that emit physiological signals including cardioverter defibrillators (ICDs), and vagus nerve stimulators.
8. Subjects who have received any investigational drug during the prior 30 days.
9. Clinically significant abnormal lab values as assesses by the Investigator.
10. Risk for suicidal behavior based on clinician assessment and a score of greater than 5 on the suicidal thought item of the MADRS or a score of 4 on the suicide item of the Hamilton Depression rating scale.
11. Subjects who have had a serious suicide attempt in the past year as assessed by the Investigator.
12. Current other somatic antidepressant therapy, i.e. vagus nerve stimulation, electroconvulsive therapy, or phototherapy.
13. Started psychotherapy in the past 30 days.

Primary outcomes:
measure: The correlations between EEG cordance or task-induced changes in frontal total Hb levels
timeFrame: 6 weeks
measure: Changes in MADRAS scores between baseline and the last treatment day
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Ofra Sarid-Segal, MD
role: PRINCIPAL_INVESTIGATOR
References: