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Neuroimaging in Patients Undergoing TMS for Depression (NIPUTFD)

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ClinicalTrials.gov Identifier: NCT02974296
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Marta Moreno Ortega, PHD, New York State Psychiatric Institute

Brief Summary:
The goal of this project is to guide rTMS using functional magnetic resonance imaging (fMRI) in individuals with depression who did not respond to standard TMS treatment to evaluate whether targeted TMS using individualized functional MRI scans produce outcome superior to that of conventional approaches. The study team also plans to scan patients with Major Depression Disorder (MDD) patients prescribed to receive standard TMS for the first time before and after which they will have resting-state Functional Magnetic Resonance Imaging (rs-FMRI) scan in order to see if we can predict their responsiveness based on the functional connectivity maps.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Device: transcranial magnetic stimulation Not Applicable

Detailed Description:

Significance: There are few therapeutic options for individuals with treatment resistant depression (TRD). One recently developed approach is rTMS over left dorsolateral prefrontal cortex. Recent studies have demonstrated overall antidepressant benefit of rTMS in patients who fail to respond to a trial of antidepressant medication (1, 2, 3). Nevertheless, for many patients the response is incomplete, suggesting the need for further optimization. One potential cause of heterogeneous response might relate to individual differences in brain anatomy and connectivity patterns. At present, the rTMS stimulation site across subjects is based upon fixed location relative to motor cortex. Potentially, however, the approach could be optimized by stimulating based upon individual brain functional connectivity pattern. The present project will collect pre- and post-treatment brain functional connectivity measures in a group of patients who will be receiving independent clinical rTMS for resistant depression, a connectivity-based targeting approach will be applied at the single-subject level to individualize therapy in those patients who do not respond to standard approaches.

Patients will be divided in 2 groups. Group 1 (N=30) will be depressed patients undergoing standard TMS for the first time. Group 2 (N=30) constitutes those who have previously demonstrated that they do not respond to standard TMS. MDD patients prescribed to receive standard TMS for the first time (group 1) will have resting-state FMRI in order to see if their responsiveness based on the functional connectivity maps can be predicted. Non-responders to standard TMS approaches (Group 2) will be randomized (3:2) to either receive targeted (N=18) or standard (N=12) repetitive TMS (rTMS) treatments. A connectivity-based targeting strategy will be used on patients undergoing targeted rTMS to optimize target for focal brain stimulation. Raters and patients in group 2 will be kept blinded to the treatment assignment. All patients referred from the ongoing treatment study will be assessed by 3 tesla brain MRI, Magnetic Resonance Spectroscopy (MRS) and Cerebral Blood Flow/Volume (CBF/CBV) procedures at baseline and immediately following the final treatment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuroimaging in Patients Undergoing TMS for Depression
Actual Study Start Date : April 30, 2017
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: new target TMS
new target transcranial magnetic stimulation guided by MRI
Device: transcranial magnetic stimulation
non invasive brain stimulation approach

Active Comparator: standard TMS
standard transcranial magnetic stimulation
Device: transcranial magnetic stimulation
non invasive brain stimulation approach




Primary Outcome Measures :
  1. Change in functional connectivity measured by resting-state MRI [ Time Frame: Week 1 prior to first TMS treatment and week 36 after completion of TMS treatments ]
    Change in functional connectivity between left dorsolateral prefrontal cortex and subgenual anterior cingulate will be measured


Secondary Outcome Measures :
  1. Change in depressive symptoms measured by the Hamilton depression rating scale (HDRS) [ Time Frame: Week 1 prior to first TMS treatment and week 36 after completion of TMS treatments ]
    Patients will be classified as responders to TMS with at least 50% decrease in HDRS scores from baseline. Patients will be classified as non-responders to TMS with less than 50% decrease in HDRS scores from baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Male or female outpatients, 18 to 60 years of age.
  2. Primary diagnosis of Major Depressive Disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM-IV-TR) Disorders (SCID-IV-TR).
  3. Duration of the index episode of at least 1 month.
  4. MDD symptoms, defined as a total HDRS-17 score ≥ 18 despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI).
  5. Individuals who cannot tolerate medications.
  6. Patients currently on medication must be at the same stable dose(s) for 1 month prior to enrollment and be willing to continue at the same dose(s) through the duration of the study.
  7. Capable and willing to provide informed consent.
  8. Signed HIPAA authorization.
  9. Right-handed.
  10. Willingness to undergo research fMRI scan (3T).
  11. Willingness to undergo randomization to either treatment arm.

General Exclusion Criteria:

  1. Investigators, and their immediate families (defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
  2. Individuals diagnosed by the investigators with the following conditions: Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime), history of substance abuse or dependence within the past year (except nicotine and caffeine).
  3. Behavior, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol.
  4. Individuals with a clinically defined neurological disorder including, but not limited to: tics, space occupying brain lesion; any history of seizures except those therapeutically induced by electroconvulsive therapy (ECT); history of cerebrovascular accident; history of fainting; transient ischemic attack within two years; cerebral aneurysm, Dementia; Parkinson's Disease; Huntington chorea; Multiple Sclerosis.
  5. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for ≥ 5 minutes.
  6. Use of any investigational drug within 12 weeks of the randomization visit.
  7. Significant acute suicide risk, defined as follow: suicide attempt within the previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or in the investigator's opinion, has significant risk for suicide based on the current state or recent history.
  8. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
  9. Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
  10. Current illicit drug use (cannabinoid, phencyclidine, amphetamines, barbiturates, cocaine, methadone, and opiates), defined as drug use during the 6 months before screening.
  11. Known or suspected pregnancy. Urine pregnancy test Women who are breast-feeding.
  12. Women of childbearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.
  13. Medicinal patch, unless removed prior to the magnetic resonance (MR) scan.
  14. MDD patients with very severe depression, defined as a total HDRS-17 score ≥ 23, will be excluded and referred to immediate treatment.
  15. Risks related to seizures, such as substance abuse or sleep disruptions/insomnia.

SpecificExclusion criteria (group 1):

History of treatment with rTMS therapy for any disorder.

Specific Inclusion criteria (group 2):

History of non-response to rTMS in this depressive episode.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974296


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Study Director: Daniel C. Javitt, MD Ph.D New York State Psychiatric Institute & Columbia University

Publications of Results:
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Responsible Party: Marta Moreno Ortega, PHD, Associate Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02974296     History of Changes
Other Study ID Numbers: 7159
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders