Back to resultsIs the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?
Primary Purpose
Pain, Secondary Hyperalgesia, Healthy Volunteers
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MRI-scan
Sponsored by
About this trial
This is an interventional basic science trial for Pain focused on measuring Pain, Secondary hyperalgesia, Healthy volunteers, Magnetic Resonance Imaging
Eligibility Criteria
Inclusion Criteria:
- Age >18 years and <35 years
- Speak and understand Danish
- Male sex
- Study participants who have understood and signed the informed consent
- No prescription medicine during the last 30 days.
- Have participated and completed the study with the identifier: NCT02527395.
Exclusion Criteria:
- Study participants that cannot cooperate to the test.
- Study participants who have a weekly intake of >21 units of alcohol, or a have consumed >3 units of alcohol within 24 hours before experimental day.
- Study participants with a substance abuse, assessed by the investigator.
- Study participants, who have consumed analgesics less than 3 days before experimental day.
- Study participants, who have consumed antihistamines less than 48 hours before experimental day.
- Study participants, who have consumed antidepressant medication during the last 30 days before experimental day.
- Study participants with chronic pain.
- Study participants with neurological illnesses.
- Study participants with psychiatric diagnoses.
- Study participants with a Body Mass Index of >30 kg/m2 or <18 kg/m2
- Study participants with Contraindications to MRI
- Study participants that decline information regarding potential pathological findings in relation to the MRI.
- Study participants that have any kind of trauma resulting in pain and administration of analgesics in the period between experimental pain testing and MRI-scan.
- Study participant that experience a head trauma in the period between the experimental pain testing and the MRI-scan.
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI-scan
Arm Description
All study participants will complete a MRI-scan of the brain
Outcomes
Primary Outcome Measures
Volume of the caudate nuclei, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2.
To investigate how close the volume of Caudate nucleus of the right and left hemisphere is associated with the size of the area of secondary hyperalgesia induced by Brief Thermal Sensitization.
Secondary Outcome Measures
Volume of cortical and subcortical areas, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2.
To investigate the association between cortical and subcortical brain areas relevant for pain processing and the area of secondary hyperalgesia (Primary somatosensory cortex, anterior and mid Cingulate cortex, Basal ganglia (Putamen, Accumbens nucleus, and Globus pallidus), Insula, and the Cerebellum.
White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2
By Diffusion Tensor Imaging to investigate the association between area of secondary hyperalgesia and white matter microstructure using tract based spatial statistics (TBSS).
White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2
By Diffusion Tensor Imaging to conduct white-matter tractography to determine the connections between cortical and subcortical brain areas relevant for pain processing (Primary somatosensory cortex, anterior and mid Cingulate cortex, Basal ganglia (Putamen, Accumbens nucleus, and Globus pallidus), Insula, and the Cerebellum)
Full Information
NCT ID
NCT02567318
First Posted
October 1, 2015
Last Updated
December 15, 2016
Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02567318
Brief Title
Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?
Official Title
Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - A Study of Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Secondary Hyperalgesia, Healthy Volunteers, Magnetic Resonance Imaging
Keywords
Pain, Secondary hyperalgesia, Healthy volunteers, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI-scan
Arm Type
Experimental
Arm Description
All study participants will complete a MRI-scan of the brain
Intervention Type
Device
Intervention Name(s)
MRI-scan
Intervention Description
Magnetic resonance imaging scan of the brain
Primary Outcome Measure Information:
Title
Volume of the caudate nuclei, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2.
Description
To investigate how close the volume of Caudate nucleus of the right and left hemisphere is associated with the size of the area of secondary hyperalgesia induced by Brief Thermal Sensitization.
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
Volume of cortical and subcortical areas, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2.
Description
To investigate the association between cortical and subcortical brain areas relevant for pain processing and the area of secondary hyperalgesia (Primary somatosensory cortex, anterior and mid Cingulate cortex, Basal ganglia (Putamen, Accumbens nucleus, and Globus pallidus), Insula, and the Cerebellum.
Time Frame
40 minutes
Title
White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2
Description
By Diffusion Tensor Imaging to investigate the association between area of secondary hyperalgesia and white matter microstructure using tract based spatial statistics (TBSS).
Time Frame
40 minutes
Title
White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2
Description
By Diffusion Tensor Imaging to conduct white-matter tractography to determine the connections between cortical and subcortical brain areas relevant for pain processing (Primary somatosensory cortex, anterior and mid Cingulate cortex, Basal ganglia (Putamen, Accumbens nucleus, and Globus pallidus), Insula, and the Cerebellum)
Time Frame
40 minutes
Other Pre-specified Outcome Measures:
Title
Volume of the nucleus caudatus, evaluated by mm3, and heat pain detection threshold, registered by degrees celsius.
Description
to investigate how close the volume of the Caudate nucleus of the right and left hemisphere is associated with the heat pain detection threshold.
Time Frame
40 minutes
Title
Volume of the nucleus caudatus, evaluated by mm3, and pain during 1 min. thermal stimulation, evaluated by maximum on the visual analog scale, 0-100mm.
Description
To investigate how close the volume of the Caudate nucleus of the right and left hemisphere is associated with the maximum visual analog score (0-100mm) during 1 min. thermal stimulation (45 degrees celsius) of the skin.
Time Frame
40 minutes
Title
Volume of the nucleus caudatus, evaluated by mm3, and pain during 1 min. thermal stimulation, evaluated by area-under-the curve of the visual analog scale, 0-100mm.
Description
To investigate how close the volume of the Caudate nucleus of the right and left hemisphere is associated with the area under the curve of the visual analog score (0-100mm) during 1 min. thermal stimulation (45 degrees celsius) of the skin.
Time Frame
40 minutes
Title
Volume of the caudate nucleus, evaluated by mm3, and scores of the Pain Catastrophizing Scale.
Description
To investigate how close the volume of Caudate nucleus of the right and left hemisphere is associated with the total score and subscores (rumination, magnification, and helplessness) of the Pain Catastrophizing Scale.
Time Frame
40 minutes
Title
Volume of the caudate nucleus, evaluated by mm3, and scores of the Hospital Anxiety and Depression Scale.
Description
To investigate how close the volume of Caudate nucleus of the right and left hemisphere is associated with the total score and subscores (Anxiety and Depression) of the Hospital Anxiety and Depression Scale.
Time Frame
40 minutes
Title
Volume of regions of interest, evaluated by mm3, and size of the area of secondary hyperalgesia, evaluated by cm2.
Description
To investigate structural differences (volume) following whole brain analyses as well as association with the size of the area of secondary hyperalgesia. When comparing healthy volunteers with a large vs. small area of secondary hyperalgesia following brief thermal sensitization defined by the upper and lower quartile.
Time Frame
40 minutes
Title
Regions of interest, evaluated by tract based spatial statistics, and size of the area of secondary hyperalgesia, evaluated by cm2.
Description
To investigate differences in the association between area of secondary hyperalgesia and regions of interest extracted from tract based spatial statistics, when comparing healthy volunteers with a large vs. small area of secondary hyperalgesia following brief thermal sensitization defined by the upper and lower quartile.
Time Frame
40 min.
Title
Differences in white matter microstructure, evaluated by white-matter tractography.
Description
To investigate differences in white matter microstructure in connections between pain related areas (Primary somatosensory cortex, anterior and mid Cingulate cortex, Basal ganglia (Putamen, Accumbens nucleus, and Globus pallidus), Insula, and the Cerebellum) evaluated by white-matter tractography, When comparing healthy volunteers with a large vs. small area of secondary hyperalgesia following brief thermal sensitization defined by the upper and lower quartile.
Time Frame
40 minutes
Title
Differences in resting state network, evaluated by fMRI.
Description
To investigate differences in resting state networks as investigated by resting state functional MRI by independent component analysis (dual regression method), when comparing healthy volunteers with a large vs. small area of secondary hyperalgesia following brief thermal sensitization defined by the upper and lower quartile.
Time Frame
40 minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age >18 years and <35 years
Speak and understand Danish
Male sex
Study participants who have understood and signed the informed consent
No prescription medicine during the last 30 days.
Have participated and completed the study with the identifier: NCT02527395.
Exclusion Criteria:
Study participants that cannot cooperate to the test.
Study participants who have a weekly intake of >21 units of alcohol, or a have consumed >3 units of alcohol within 24 hours before experimental day.
Study participants with a substance abuse, assessed by the investigator.
Study participants, who have consumed analgesics less than 3 days before experimental day.
Study participants, who have consumed antihistamines less than 48 hours before experimental day.
Study participants, who have consumed antidepressant medication during the last 30 days before experimental day.
Study participants with chronic pain.
Study participants with neurological illnesses.
Study participants with psychiatric diagnoses.
Study participants with a Body Mass Index of >30 kg/m2 or <18 kg/m2
Study participants with Contraindications to MRI
Study participants that decline information regarding potential pathological findings in relation to the MRI.
Study participants that have any kind of trauma resulting in pain and administration of analgesics in the period between experimental pain testing and MRI-scan.
Study participant that experience a head trauma in the period between the experimental pain testing and the MRI-scan.
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
27317630
Citation
Hansen MS, Asghar MS, Wetterslev J, Pipper CB, Johan Martensson J, Becerra L, Christensen A, Nybing JD, Havsteen I, Boesen M, Dahl JB. Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - Protocol for a 3-Tesla MRI Study of Healthy Volunteers. JMIR Res Protoc. 2016 Jun 17;5(2):e117. doi: 10.2196/resprot.5680.
Results Reference
derived
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Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?
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