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

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.

Study Overview

• Status: Terminated
• Conditions: Depression
• Intervention / Treatment: Procedure: Transcranial Magnetic Stimulation (TMS); Device: near infrared spectroscopy (NIRS)

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Depressed outpatients treated with TMS; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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.	6 Weeks

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Boston Medical Center
• Investigators: Principal Investigator: Ofra Sarid-Segal, MD, Boston University

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 30, 2010
• First Submitted That Met QC Criteria: August 31, 2010
• First Posted (Estimate): September 1, 2010

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Transcranial Magnetic Stimulation; TMS; Depressed
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: H-29098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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