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

NCT01192685 | Terminated Early Phase 1 DMC FDA Device

• 1 other identifier: H-29098
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Depressed; TMS; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Depressed outpatients treated with TMS

OTHER

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); Device: near infrared spectroscopy (NIRS)

Interventions

Transcranial Magnetic Stimulation (TMS) PROCEDURE

TMS will be administered to subjects 5 days a week-typically Monday through Friday, for 6 weeks.

Depressed outpatients treated with TMS

near infrared spectroscopy (NIRS) DEVICE

near infrared spectroscopy (NIRS) will be used to measure the blood flow in the brain

Depressed outpatients treated with TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead
• Boston Medical Center: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Depression; Consciousness Disorders

Interventions

Transcranial Magnetic Stimulation; Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ofra Sarid-Segal, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)