Brain MRI (Magnetic Resonance Imaging) Scans of Patients With Treatment Resistant Depression (TRD) and Healthy Controls
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|ClinicalTrials.gov Identifier: NCT01162434|
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : July 12, 2012
|Condition or disease|
All the patients treated at Frenchay Hospital, UK, with deep brain stimulation (DBS) for treatment resistant depression (TRD) will be given a Patient Information Sheet, and asked if they would like to participate in this research related to their condition. If they indicate they would like to participate, patients will be asked to sign a separate informed consent form (ICF) to give permission for their previously collected MRI scan to be used for this new research purpose. Information on handedness of the patients has not been previously collected, so patients will be given a short questionnaire to determine their handedness. The patients will not be required to perform any further tasks.
For each patient that agrees to participate in the study, two healthy matched control participants will be recruited. Participants will be recruited from an existing volunteer database and by local advertisements.
Respondents interested in participating will be given a letter of invite and a participant information sheet. They will be asked several basic questions including contact details, health status, age, sex, handedness, highest qualification achieved, and scanning requirements in order to assess their basic suitability for the study. If suitable, participants will be invited to attend a screening visit. Here, the informed consent form will be signed, then their medical history will be taken, and they will be given a MINI neuropsychiatric evaluation to assess their physical and mental status. Females who have the possibility of being pregnant will be asked to provide a urine sample to check they are not pregnant, and will be required to use adequate contraception until after their scan.
If suitable, participants will complete two computerised tests of mood. Then they will have a scan date booked at Frenchay hospital. At the scanning visit, participants will be assessed for any changes in health since their screening visit, and then will complete an MRI scan. The same scanner with the same sequences will be used for the healthy controls that were used for the patients. Two sequences will be collected: a coronal T1 FFE (fast field echo) volume acquisition and an axial high resolution T2 limited volume acquisition where 16 slices are collected with 8 above the ACPC (anterior commissure posterior commissure) plane and 8 below. These sequences match the sequences that our DBS patients have had and will allow both automated anatomical quantitative analysis (using Statistical Parametric Mapping version 5 (SPM5)) and quantitative description of other MRI signals such as white matter bright spots. Participants will receive no payment, but can have a printout of their scan if they wish.
The scans will then be analysed and compared to the patient scans.
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Observational Model:||Case Control|
|Official Title:||Volumetric Brain MRI (Magnetic Resonance Imaging) Comparison of Patients With Treatment Resistant Depression (TRD) Undergoing Deep Brain Stimulation (DBS) With Age, Sex and Education Matched Healthy Controls|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Up to 8 patients who have received Deep Brain Stimulation for Treatment Resistant Depression at Frenchay Hospital (UK) will be recruited.
Up to 16 healthy volunteers, matched to the DBS patients on age, sex, handedness, and education, will be recruited.
- Region of interest analysis [ Time Frame: 6 months ]Comparison of RoI volumes of specific brain structures between patients with TRD undergoing deep brain stimulation (DBS) and healthy volunteers. Specific brain regions are: hippocampus, orbitofrontal cortex and subgenual cingulate, amygdala, dorsal anterior cingulate cortex, and dorsomedial prefrontal cortex.
- Whole brain analysis [ Time Frame: 6 months ]Whole brain MRI volumetric comparison between TRD patients undergoing DBS and healthy volunteers.
- Comparison of abnormalities [ Time Frame: 6 months ]Comparison of other potential abnormalities e.g. areas of hyperintensity in white matter in specific brain volumes between patients with TRD undergoing DBS and healthy volunteers.
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): NCT01162434
|Bristol Royal Infirmary|
|Bristol, United Kingdom, BS2 8HW|
|Principal Investigator:||Andrea Malizia, MD||University of Bristol|