Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01192685
First received: August 30, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Depression
Device: Transcranial Magnetic Stimulation (TMS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Transcranial Magnetic Stimulation in Major Depression With EEG and NIRS Monitoring

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • The correlations between EEG cordance or task-induced changes in frontal total Hb levels [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Changes in MADRAS scores between baseline and the last treatment day [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    The primary outcomes 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.


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcranial Magnetic Stimulation (TMS)
    TMS will be administered to subjects 5 days a week-typically Monday through Friday, for 6 weeks.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192685

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Boston Medical Center
Investigators
Principal Investigator: Ofra Sarid-Segal, MD Boston University
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01192685     History of Changes
Other Study ID Numbers: H-29098
Study First Received: August 30, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
Depression
Depressed
TMS
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014