Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01162434
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2010-07-13
Brief Title:
Brain MRI Magnetic Resonance Imaging Scans of Patients With Treatment Resistant Depression TRD and Healthy Controls
Sponsor:
University of Bristol
Organization:
University of Bristol
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatment resistant depression TRD is a major health concern with 10 of patients with major depressive disorder not responding to conventional treatments The investigators propose to compare the MRI magnetic resonance imaging brain scans of patients with TRD which were collected during surgical planning for deep brain stimulation with age sex handedness and education-matched healthy volunteer controls to investigate anatomical differences specifically the volume of certain brain structures
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10H010215 | OTHER | Southmead REC | None |