N/A
N=45
Investigation of Brain Network Dynamics in Depression
Major Depressive Disorder, Recurrent
Bottom Line
View on ClinicalTrials.gov: NCT01931995 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Relative Changes in Corticolimbic Functional Connectivity as a Result of TMS — -0.11; -0.19 Fisher transformed z values
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TMS positively correlated DLPFC (Device); TMS to negatively correlated DLPFC (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Changes in Corticolimbic Functional Connectivity as a Result of TMS |
-0.11; -0.19 | — |
| SECONDARY Changes in Local Glucose Metabolism at Corticolimbic Network Nodes |
-0.06; 0.054 | — |
Summary
This research study is being done to gain a better understanding about brain networks that may be involved in depression. The investigators plan to examine how these networks change after the brain is stimulated with "Transcranial Magnetic Stimulation" (TMS). TMS is a way of stimulating the brain in order to mildly activate or mildly suppress different brain areas, and is used to treat some forms of depression. It is hoped that this study will facilitate learning more about the structure and function of different brain areas and the ways that they are interconnected to form networks, both in depressed people and in people without depression. In this research study, the effects of TMS will be measured by obtaining "pictures" of the brain with "Magnetic Resonance Imaging" (MRI) and with "Positron Emission Tomography" (PET). More specifically, this will be accomplished with a combined MRI and PET scanner, which is capable of simultaneously obtaining both MRI and PET images of the brain. This scanning paradigm will allow the assessment of local metabolic changes resulting from TMS (with PET images) and brain network changes resulting from TMS (with fMRI). Changes resulting from TMS between 20 subjects with depression and 20 healthy volunteers will be calculated and will form the main outcome measure.
Eligibility Criteria
Inclusion Criteria
- Ages 18-50
- Patients with Major Depressive Disorder, as confirmed by a referring provider, DSM-IVR criteria, and/or a Structured Clinical Interview (SCID)
- Score of ≥18 on the 24 item version of the Hamilton Depression Rating Scale (HDRS)
- Meeting criteria to safely receive fMRI scanning, PET scanning and rTMS.
Exclusion Criteria
- Any subject who is pregnant or lactating
- Patients with bipolar disorder, schizoaffective disorder, suicidal ideation, or any history of psychosis. Concurrent anxiety disorders will be allowed.
- Any serious concurrent medical or neurological illness
- Any contraindication to receiving TMS, fMRI or PET scans including, but not limited to having: a pacemaker, metallic implants, implanted pumps, surgical aneurysm clips, history of severe head trauma, history of seizures or a first degree relative with epilepsy, been involved in a nuclear medicine study in the past 12 months, diabetes
Data sourced from ClinicalTrials.gov (NCT01931995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.