Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?

Pain Clinical Trial

Official title:

Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - A Study of Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567318
• Other study ID #: SM3-MSH-2015
• Status: Completed
• Phase: N/A
• First received: October 1, 2015
• Last updated: December 15, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers
• Hyperalgesia
• Magnetic Resonance Imaging
• Neoplasm Metastasis
• Pain
• Secondary Hyperalgesia

Intervention

Device:
• MRI-scan
Magnetic resonance imaging scan of the brain

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Volume of the nucleus caudatus, evaluated by mm3, and heat pain detection threshold, registered by degrees celsius.	to investigate how close the volume of the Caudate nucleus of the right and left hemisphere is associated with the heat pain detection threshold.	40 minutes	No
Other	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.	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.	40 minutes	No
Other	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.	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.	40 minutes	No
Other	Volume of the caudate nucleus, evaluated by mm3, and scores of the Pain Catastrophizing Scale.	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.	40 minutes	No
Other	Volume of the caudate nucleus, evaluated by mm3, and scores of the Hospital Anxiety and Depression Scale.	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.	40 minutes	No
Other	Volume of regions of interest, evaluated by mm3, and size of the area of secondary hyperalgesia, evaluated by cm2.	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.	40 minutes	No
Other	Regions of interest, evaluated by tract based spatial statistics, and size of the area of secondary hyperalgesia, evaluated by cm2.	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.	40 min.	No
Other	Differences in white matter microstructure, evaluated by white-matter tractography.	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.	40 minutes	No
Other	Differences in resting state network, evaluated by fMRI.	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.	40 minutes	No
Primary	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.	40 minutes	No
Secondary	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.	40 minutes	No
Secondary	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).	40 minutes	No
Secondary	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)	40 minutes	No