Functional Brain Imaging Study of Response to Repetitive TMS (rTMS) Treatment of Major Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Mclean Hospital
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Yunjie Tong, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01768052
First received: January 8, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

The investigators plan to use optical brain imaging technology to observe patients with current major depression before, during, and after repetitive Transcranial Magnetic Stimulation (rTMS) clinical treatment. Clinical treatment involves 20-30 rTMS sessions over the course of 4-6 weeks.

Our primary hypotheses are as follows:

  1. Primary Hypothesis: In patients with a positive response to rTMS, the investigators will observe an increase in the strength of connectivity as measured by fMRI among brain regions in the cognitive control network after 4 weeks of treatment.
  2. Secondary Hypothesis: Brain activation measured by functional Near-Infrared Spectroscopy(fNIRS) in the dorso-lateral prefrontal cortex (DLPFC) during rTMS will increase as the number of treatments increase. Detection of this increase in brain activity at the beginning of the treatment help researchers and physicians assess treatment response.

Condition Intervention
Major Depression
Device: functional Near Infrared Spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multimodal Functional Brain Imaging Study of Response to Repetitive TMS (rTMS) Treatment of Major Depression

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Change in the connectivity strength in the CCN as assessed by fMRI [ Time Frame: Participants will be followed for the duration of their TMS treatment and pre- and post-fMRI scans, an expected average of 5-7 weeks ] [ Designated as safety issue: No ]

    •To determine if an increase in the strength of connectivity as measured by fMRI among brain regions in the CCN is observed after 4 weeks of treatment (approximately 20 treatment sessions) in patients with a positive response to rTMS.

    Participants will undergo fMRI scans prior to beginning TMS treatment (Week 0) and after completing TMS treatment (Weeks 5-7, depending on length of treatment time). Participants will undergo fNIRS monitoring during the TMS treatment sessions (average: Weeks 1-4).



Secondary Outcome Measures:
  • Change in brain activation in DLPFC as assessed by fNIRS monitoring [ Time Frame: Participants will be followed for the duration of their TMS treatment, an expected average of 4-6 weeks ] [ Designated as safety issue: No ]

    •To determine if brain activation measured by fNIRS in the DLPFC during rTMS will increase as the number of treatments increase, as detection of this increase in brain activity at the beginning of treatment may be a marker for positive treatment outcome.

    Participants will undergo fMRI scans prior to beginning TMS treatment (Week 0) and after completing TMS treatment (Weeks 5-7, depending on length of treatment time). Participants will undergo fNIRS monitoring during the TMS treatment sessions (average: Weeks 1-4).



Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
functional Near Infrared Spectroscopy
Noninvasive functional Near Infrared Spectroscopy (fNIRS) monitoring will take place during patients' clinical rTMS treatment sessions.
Device: functional Near Infrared Spectroscopy
fNIRS monitoring during rTMS treatment sessions.
Other Name: ISS Imagent

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male and female participants with major depressive disorder (single or recurrent episode), current episode depressed with current episode duration of three years or less.

Of note, subjects are referred by the Transcranial Magnetic Stimulation (TMS) Service at McLean Hospital only.

Criteria

Inclusion Criteria:

  1. Subjects must be 21-45 years old.
  2. Current episode of depression must be of a duration of three years or less
  3. Participants must have a score of 18 or more on the 24-item version of the HDRS
  4. Participants must have failed at least one adequate trial of antidepressant medication in this or the most recent depressive episode, but not more than four medications.

    •Alternatively, they can have shown an inability to tolerate four such agents due to side effects

  5. Participants may be medicated or un-medicated.

    •Medication adjustments may be introduced during the course of the TMS treatment by his or her primary psychiatrist in consultation with Dr. Morales. At the discretion of the PI and study physician, subjects that begin taking or undergo a change in certain medications known to influence mood or vascular circulation may be excluded from the study analysis. Exclusion from the analysis will not affect their clinical treatment.

  6. Women entering this study must complete a urine pregnancy screen prior to fMRI scanning unless they are post-menopausal, clinically defined as no menses in greater than 12 months or having had surgical removal of the ovaries.
  7. Subjects must be in inpatient/outpatient treatment with a prescribing mental health clinician.
  8. Subjects will meet DSM-IV criteria for or Major Depressive Disorder and be currently depressed.
  9. Subject must have a HAM-D score ≥ 18 and a MADRS score > 18.

    •At the discretion of a study psychiatrist or PI, a HAM-D/MADRS score of less than 18 may be accepted if enough depressive symptoms are present and the subject meets DSM criteria for depression.

  10. Capable of giving informed consent, including compliance with restrictions and restrictions listed on consent form.

Exclusion Criteria:

  1. Currently pregnant or planning to be pregnant during the course of the study, as verified by positive pregnancy test on fMRI scan days, or childbearing potential and not using adequate contraception. Adequate contraception includes birth control pills, birth control shots, or a non-metallic, MRI-compatible intrauterine device (IUD). Those not of childbearing potential include post-menopausal for more than 6 months, surgically sterilized, or male participants.
  2. Active neurological diseases, history of seizure disorder, dementias, or acute medically unstable or unmanaged physical illnesses.
  3. Failed more than four antidepressant medications in this or the most recent depressive episode
  4. Any contraindication to MRI scanning as assessed by pre-screening MRI questionnaire (including, but not limited to, the presence of ferrous implant, pacemaker, etc…).
  5. History of clinically significant claustrophobia.
  6. Weight greater than 250 pounds (>113.4kg).
  7. Evidence of drug use, nicotine use, alcohol use, or caffeine use by participant and/or clinical observation on the fMRI scanning days.
  8. Any clinically significant brain structural abnormalities per patient's medical history or per report generated from the clinical structural scan performed during baseline scanning. Per the discretion of the study physician and the principal investigator, subjects who meet this exclusion criterion may be included in the research study and excluded from the study analysis.
  9. Patients who, in the investigators' judgment, will not likely be able to comply with the study protocol.
  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: NCT01768052

Contacts
Contact: Yunjie Tong, PhD 617-855-3620 ytong@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Imaging Center/McLean TMS Service Recruiting
Belmont, Massachusetts, United States, 02478
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Yunjie Tong, Ph.D.    617-855-3620    ytong@mclean.harvard.edu   
Sponsors and Collaborators
Mclean Hospital
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Yunjie Tong, PhD Mclean Hospital
Study Director: Blaise Frederick, Ph.D. Mclean Hospital
Study Director: Oscar Morales, M.D. McLean Hospital, Transcranial Magnetic Stimulation (TMS) Service
  More Information

Publications:
Tong, Y. and B.D. Frederick, Time lag dependent multimodal processing of concurrent fMRI and near-infrared spectroscopy (NIRS) data suggests a global circulatory origin for low-frequency oscillation signals in human brain. NeuroImage, 2010. 53(2): p. 553-64.

Responsible Party: Yunjie Tong, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01768052     History of Changes
Other Study ID Numbers: 2012P002394
Study First Received: January 8, 2013
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
MDD, major depression, treatment-resistant

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

ClinicalTrials.gov processed this record on July 29, 2014