Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT02567318
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2015-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - A Study of Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2016-12
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:
The purpose of this prospective study is to investigate the degree of association between the volume of important pain-relevant structures in the brain and the size of the areas of secondary hyperalgesia.
Detailed Description:
The healthy study participants will be included from the cohort of a previous study (NCT02527395) where areas of secondary hyperalgesia, heat pain detection thresholds, pain during 1 min. thermal stimulation and test results from the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Score will be retrieved. The study consists of 1 study day. The study day will be conducted at a maximum of 2 months and a minimum of 2 weeks after the completion of the previous study (NCT02527395).The results of the previous study (NCT02527395) will be blinded until all participants have completed the study day.
All study participants will complete a MRI-scan of the brain.
The MRI scans will be performed with a Siemens MAGNETOM Verio 3 tesla, with b17 software, and a 32-channel head coil. The MRI-scan sequence is as follows:
* 3D Localiser
* 3D T1 weighted iso
* AX Diffusion tensor imaging
* AX Epi resting state fMRI
* AX Gre field map
* AX Epi ASL
* AX T2-weighted blade
* AX T2-weighted flair
* AX T2-weighted\* Gre
Total MRI-scan time is estimated to approximately 40 minutes.
All study participants will complete a MRI-scan of the brain.
The MRI scans will be performed with a Siemens MAGNETOM Verio 3 tesla, with b17 software, and a 32-channel head coil. The MRI-scan sequence is as follows:
* 3D Localiser
* 3D T1 weighted iso
* AX Diffusion tensor imaging
* AX Epi resting state fMRI
* AX Gre field map
* AX Epi ASL
* AX T2-weighted blade
* AX T2-weighted flair
* AX T2-weighted\* Gre
Total MRI-scan time is estimated to approximately 40 minutes.
Study Oversight
Has Oversight DMC:
True
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?: