Clinical trial NCT02567318: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Secondary Hyperalgesia
Healthy Volunteers
Magnetic Resonance Imaging
Keywords: Pain
Secondary hyperalgesia
Healthy volunteers
Magnetic Resonance Imaging
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: University of Copenhagen
First posted: 2015-10-02
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Volume of the caudate nuclei, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2.
timeFrame: 40 minutes
Secondary outcomes:
measure: Volume of cortical and subcortical areas, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2.
timeFrame: 40 minutes
measure: White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2
timeFrame: 40 minutes
measure: White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2
timeFrame: 40 minutes
Other outcomes:
measure: Volume of the nucleus caudatus, evaluated by mm3, and heat pain detection threshold, registered by degrees celsius.
timeFrame: 40 minutes
measure: 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.
timeFrame: 40 minutes
measure: 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.
timeFrame: 40 minutes
measure: Volume of the caudate nucleus, evaluated by mm3, and scores of the Pain Catastrophizing Scale.
timeFrame: 40 minutes
measure: Volume of the caudate nucleus, evaluated by mm3, and scores of the Hospital Anxiety and Depression Scale.
timeFrame: 40 minutes
measure: Volume of regions of interest, evaluated by mm3, and size of the area of secondary hyperalgesia, evaluated by cm2.
timeFrame: 40 minutes
measure: Regions of interest, evaluated by tract based spatial statistics, and size of the area of secondary hyperalgesia, evaluated by cm2.
timeFrame: 40 min.
measure: Differences in white matter microstructure, evaluated by white-matter tractography.
timeFrame: 40 minutes
measure: Differences in resting state network, evaluated by fMRI.
timeFrame: 40 minutes
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
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.