Repetitive Transcranial Magnetic Stimulation for Treating Depression: A Functional Magnetic Resonance Imaging Study
| Status: | Terminated |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 2/20/2019 |
| Start Date: | January 2010 |
| End Date: | September 2013 |
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder: A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study
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.
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.
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.
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.
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.
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