Repetitive Transcranial Magnetic Stimulation for Treating Depression: A Functional Magnetic Resonance Imaging Study

This study has suspended participant recruitment.
(Protocol currently undergoing changes. Will be relisted at later date.)
Sponsor:
Information provided by (Responsible Party):
Kathy Pierce, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01162382
First received: November 30, 2009
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

This protocol, "Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder (MDD): A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study," is an open-label pilot treatment study. The purpose of the present protocol is to treat participants with a diagnosis of Major Depressive Disorder with 4 weeks of rTMS, performing fcMRI and EEG studies prior to and following treatment to determine if treatment response is related to changes in fcMRI and/or EEG results. The investigators hypothesize that patients who respond to treatment will display changes in functional connectivity patterns thought to be related to the occurrence of depressive symptoms.


Condition Intervention
Major Depressive Disorder
Device: Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder: A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale-24 point version (HDRS-24) [ Time Frame: At study entry and within 2 days of exiting 4 weeks of rTMS treatment ] [ Designated as safety issue: No ]
    HDRS-24 will be used to measure response to rTMS treatment. A 50% decrease in HDRS-24 score will indicate treatment response; HDRS-24 < 10 will indicate remission.


Secondary Outcome Measures:
  • fCMRI results [ Time Frame: At study entry and within 2 days of exiting 4 weeks of rTMS treatment ] [ Designated as safety issue: No ]
    Imaging studies will be compared to determine if any changes in functional connectivity can be correlated with treatment response.


Estimated Enrollment: 35
Study Start Date: January 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial Magnetic Stimulation
Open-label transcranial magnetic stimulation
Device: Transcranial Magnetic Stimulation
Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.
Other Name: Magstim Rapid stimulator

Detailed Description:

Depression is accompanied by rumination that supports inwardly focused cognitive attention on negative events and emotions. There is evidence to indicate that one aspect of this ruminative behavior lies in an abnormal increase in intra-regional connectivity among elements of the default mode network (DMN). It is also widely recognized that depression is associated with disturbances of cognition that include deficits in attentional processing, including both reductions in processing speed and deficits in selective attentional processing that are considered a part of executive function. Thus, there is at least equal reason to believe that attention and executive control networks might show changes in intra-regional functional connectivity. Given the attentional deficits associated with MDD, we hypothesize that there will be a weakening of intra-network resting state BOLD functional connectivity (rs-fcMRI) in addition to the strengthened connectivity reported by others.Further, we suggest that these shifts in intra-regional connectivity extend to the well-recognized anti-correlated activity between these two networks and support the intrusion of introspective, ruminative thought on cognitive activities that require externally directed attention. To test this hypothesis, we will use fMRI resting state functional connectivity to examine shifts in network connectivity prior to and following rTMS treatment for depression.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

SCREENING/DIAGNOSTIC REQUIREMENTS:

  • Male or female outpatients, ages 18-50 (some literature has shown increasing cortical distance with age that may affect treatment outcome
  • Hamilton Rating Scale of Depression (HRSD-24) > 18
  • New onset major depression or untreated recurrent major depression per DSM-IV-TR38 criteria.
  • Not taking antidepressant medication or any other psychotropic medication
  • Using an adequate contraceptive method
  • Able to give informed consent
  • Available for 4 weeks of daily therapy, working hours, Mon.-Fri.
  • English-speaking

Exclusion Criteria:

DIAGNOSTIC EXCLUSIONS:

  • Co-morbid psychiatric diagnosis of bipolar disorder, acute OCD, schizophrenia or schizoaffective or concurrent treatment with outpatient ECT, or personality disorder or MDD with suicidal ideation as determined by history and/or by P.I. examination requiring hospital admission or referral for acute care.
  • Previous failure to respond to treatment with rTMS
  • Failure to achieve satisfactory improvement in depression after two or more adequate trials of antidepressant medications.

MEDICAL EXCLUSIONS:

  • Patients newly diagnosed with thyroid dysfunction
  • History of drug and/or ETOH dependence
  • History of seizures
  • History of head injury with loss of consciousness > 5 minutes
  • Any implantable metal object in the skull or near their head
  • Any implantable devices such as a cardiac pacemaker, vagal nerve stimulator, etc.
  • Positive urine pregnancy test
  • Severe migraine headaches uncontrolled with routine non-narcotic medication
  • Any medical condition in the opinion of the Investigator that might confound the results of the study Contraindications to fcMRI procedure
  • Intake of NSAIDS, narcotic or muscle relaxants within 72 hours of the fMRI protocol.
  • Claustrophobia.
  • Left-handedness (may influence cerebral cortical hemispheric dominance).
  • Inability to tolerate, or medical contraindication to MRI testing (e.g. metal prostheses or implants, history of claustrophobia)

PROTOCOL SPECIFIC EXCLUSIONS:

  • Unable to determine motor threshold for determining treatment dose with rTMS device
  • Mini Mental Status Exam (MMSE)70 score < 24.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162382

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jose Garcia, MD Washington University School of Medicine
  More Information

Publications:
Responsible Party: Kathy Pierce, Research Statistician, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01162382     History of Changes
Other Study ID Numbers: WUSM3621222
Study First Received: November 30, 2009
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
transcranial magnetic stimulation
TMS
rTMS
depression
fcMRI
EEG

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

ClinicalTrials.gov processed this record on April 23, 2014