Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring
| Status: | Terminated |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2017 |
| Start Date: | December 2012 |
| End Date: | December 2013 |
Transcranial Magnetic Stimulation in Major Depression With EEG and 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 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.
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.
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.
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.
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.
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