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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT02567318

Collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research (Other), University of Copenhagen (Other)

120

Enrollment

Location

Arm

Duration (Months)

59.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Secondary Hyperalgesia Healthy Volunteers Magnetic Resonance Imaging	Device: MRI-scan	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MRI-scan All study participants will complete a MRI-scan of the brain	Device: MRI-scan Magnetic resonance imaging scan of the brain

Arm

Intervention/Treatment

Experimental: MRI-scan

All study participants will complete a MRI-scan of the brain

Device: MRI-scan

Magnetic resonance imaging scan of the brain

Outcome Measures

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. [40 minutes]
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. [40 minutes]
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 [40 minutes]
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 [40 minutes]
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)

Other Outcome Measures

Volume of the nucleus caudatus, evaluated by mm3, and heat pain detection threshold, registered by degrees celsius. [40 minutes]
to investigate how close the volume of the Caudate nucleus of the right and left hemisphere is associated with the heat pain detection threshold.
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. [40 minutes]
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.
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. [40 minutes]
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.
Volume of the caudate nucleus, evaluated by mm3, and scores of the Pain Catastrophizing Scale. [40 minutes]
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.
Volume of the caudate nucleus, evaluated by mm3, and scores of the Hospital Anxiety and Depression Scale. [40 minutes]
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.
Volume of regions of interest, evaluated by mm3, and size of the area of secondary hyperalgesia, evaluated by cm2. [40 minutes]
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.
Regions of interest, evaluated by tract based spatial statistics, and size of the area of secondary hyperalgesia, evaluated by cm2. [40 min.]
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.
Differences in white matter microstructure, evaluated by white-matter tractography. [40 minutes]
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.
Differences in resting state network, evaluated by fMRI. [40 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.