Neuroimaging in Patients Undergoing TMS for Depression

NCT02974296 | Completed Results FDA Device

• 1 other identifier: 7159
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Change in Functional Connectivity Measured by Resting MRI

  Change from Baseline in Resting MRI Correlation Coefficients Between Left Dorsolateral Prefrontal Cortex and Subgenual Anterior Cingulate Change in Resting MRI is defined as post-pre

  Week 1 prior to first TMS treatment and week 36 after completion of TMS treatments

Secondary Outcomes (1)

• Change in Depressive Symptoms Measured by the Hamilton Depression Rating Scale (17-item HDRS)

  Week 1 prior to first TMS treatment and week 36 after completion of TMS treatments

Study Arms (2)

new target TMS

EXPERIMENTAL

new target transcranial magnetic stimulation guided by MRI

Device: transcranial magnetic stimulation

standard TMS

ACTIVE COMPARATOR

standard transcranial magnetic stimulation

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

non invasive brain stimulation approach

new target TMS; standard TMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female outpatients, 18 to 60 years of age.
• 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).
• Duration of the index episode of at least 1 month.
• MDD symptoms, defined as a total HDRS-17 score ≥ 18 despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI).
• Individuals who cannot tolerate medications.
• 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.
• Capable and willing to provide informed consent.
• Signed HIPAA authorization.
• Right-handed.
• Willingness to undergo research fMRI scan (3T).
• Willingness to undergo randomization to either treatment arm.

You may not qualify if:

• Investigators, and their immediate families (defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
• 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).
• Behavior, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol.
• 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.
• 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.
• Use of any investigational drug within 12 weeks of the randomization visit.
• 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.
• Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
• 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.
• Current illicit drug use (cannabinoid, phencyclidine, amphetamines, barbiturates, cocaine, methadone, and opiates), defined as drug use during the 6 months before screening.
• Known or suspected pregnancy. Urine pregnancy test Women who are breast-feeding.
• Women of childbearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.
• Medicinal patch, unless removed prior to the magnetic resonance (MR) scan.
• MDD patients with very severe depression, defined as a total HDRS-17 score ≥ 23, will be excluded and referred to immediate treatment.
• Risks related to seizures, such as substance abuse or sleep disruptions/insomnia.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Moreno-Ortega M, Kangarlu A, Lee S, Perera T, Kangarlu J, Palomo T, Glasser MF, Javitt DC. Parcel-guided rTMS for depression. Transl Psychiatry. 2020 Aug 12;10(1):283. doi: 10.1038/s41398-020-00970-8.

  PMID: 32788580 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: DR. Marta Moreno-Ortega
• Organization: Columbia University

mm4355@cumc.columbia.edu

9142187311

Study Officials

• Daniel C. Javitt, MD Ph.D

  New York State Psychiatric Institute & Columbia University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 28, 2016
• Study Start: April 30, 2017
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: October 23, 2020
• Results First Posted: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)