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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01192685
• Date of registration: 30/08/2010
• Prospective Registration: Yes
• Primary sponsor: Boston University
• Public title: Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring
• Scientific title: Transcranial Magnetic Stimulation in Major Depression With EEG and NIRS Monitoring
• Date of first enrolment: December 2012
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01192685
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Ofra Sarid-Segal, MD
• Affiliation: Boston University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Procedure: Transcranial Magnetic Stimulation (TMS)

Device: near infrared spectroscopy (NIRS)

Primary Outcome(s)

The correlations between EEG cordance or task-induced changes in frontal total Hb levels [Time Frame: 6 weeks]

Changes in MADRAS scores between baseline and the last treatment day [Time Frame: 6 Weeks]

Secondary ID(s)

H-29098

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boston Medical Center