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

Primary Purpose

Depression

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
near infrared spectroscopy (NIRS)
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Depression focused on measuring Depression, Depressed, TMS, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Depressed outpatients treated with TMS

Arm Description

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. Transcranial Magnetic Stimulation (TMS) will be administered to subjects 5 days a week for 6 weeks. Near infrared spectroscopy (NIRS), a spectroscopic method that uses the near infrared region of the electromagnetic spectrum (from about 700 nm to 2500 nm), will be used to assess blood flow in the brain.

Outcomes

Primary Outcome Measures

The correlations between EEG cordance or task-induced changes in frontal total Hb levels
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
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.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2010
Last Updated
April 19, 2017
Sponsor
Boston University
Collaborators
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01192685
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Neuronavigation system equipment failure caused unreliable data
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Depressed, TMS, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depressed outpatients treated with TMS
Arm Type
Other
Arm Description
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. Transcranial Magnetic Stimulation (TMS) will be administered to subjects 5 days a week for 6 weeks. Near infrared spectroscopy (NIRS), a spectroscopic method that uses the near infrared region of the electromagnetic spectrum (from about 700 nm to 2500 nm), will be used to assess blood flow in the brain.
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
TMS will be administered to subjects 5 days a week-typically Monday through Friday, for 6 weeks.
Intervention Type
Device
Intervention Name(s)
near infrared spectroscopy (NIRS)
Intervention Description
near infrared spectroscopy (NIRS) will be used to measure the blood flow in the brain
Primary Outcome Measure Information:
Title
The correlations between EEG cordance or task-induced changes in frontal total Hb levels
Description
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.
Time Frame
6 weeks
Title
Changes in MADRAS scores between baseline and the last treatment day
Description
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.
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria List Depressive disorder Diagnostic Statistical Manual of Mental Disorders, fourth Edition, Text Revision (DSM-IV-TR). 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. Male or female aged 18 to 65. Females who are not pregnant or nursing. Individuals able to provide informed written consent and are able to comply with study procedures. Subjects who have received or are receiving anti-depressant medication. 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 Any Axis I diagnosis that, in the opinion of the investigators, may interfere with the course of the trial. Any current diagnoses of alcohol abuse or dependence. Any current substance use disorder. Medical or neurological illness that in the investigators judgment would make study compliance difficult or would be a contraindication for use with TMS. Currently receiving any medication that markedly increases the risks for seizures, for example: tricyclic antidepressants, INH, meperidine, lidocaine, and clozapine. 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. Subjects who have implanted devices that emit physiological signals including cardioverter defibrillators (ICDs), and vagus nerve stimulators. Subjects who have received any investigational drug during the prior 30 days. Clinically significant abnormal lab values as assesses by the Investigator. 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. Subjects who have had a serious suicide attempt in the past year as assessed by the Investigator. Current other somatic antidepressant therapy, i.e. vagus nerve stimulation, electroconvulsive therapy, or phototherapy. Started psychotherapy in the past 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofra Sarid-Segal, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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