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Trial record 1 of 1 for:    NCT02567318
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Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?

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ClinicalTrials.gov Identifier: NCT02567318
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : December 16, 2016
Sponsor:
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
Information provided by (Responsible Party):
Morten Sejer Hansen, Rigshospitalet, Denmark

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Volume of the caudate nuclei, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2. [ Time Frame: 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 :
  1. Volume of cortical and subcortical areas, evaluated by mm3, and size of the area of secondary hyperalgesia following brief thermal sensitization, evaluated by cm2. [ Time Frame: 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.

  2. White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2 [ Time Frame: 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).

  3. White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2 [ Time Frame: 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:
  1. Volume of the nucleus caudatus, evaluated by mm3, and heat pain detection threshold, registered by degrees celsius. [ Time Frame: 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.

  2. 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. [ Time Frame: 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.

  3. 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. [ Time Frame: 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.

  4. Volume of the caudate nucleus, evaluated by mm3, and scores of the Pain Catastrophizing Scale. [ Time Frame: 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.

  5. Volume of the caudate nucleus, evaluated by mm3, and scores of the Hospital Anxiety and Depression Scale. [ Time Frame: 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.

  6. Volume of regions of interest, evaluated by mm3, and size of the area of secondary hyperalgesia, evaluated by cm2. [ Time Frame: 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.

  7. Regions of interest, evaluated by tract based spatial statistics, and size of the area of secondary hyperalgesia, evaluated by cm2. [ Time Frame: 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.

  8. Differences in white matter microstructure, evaluated by white-matter tractography. [ Time Frame: 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.

  9. Differences in resting state network, evaluated by fMRI. [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567318


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Morten Sejer Hansen, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02567318    
Other Study ID Numbers: SM3-MSH-2015
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Keywords provided by Morten Sejer Hansen, Rigshospitalet, Denmark:
Pain
Secondary hyperalgesia
Healthy volunteers
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperalgesia
Neoplastic Processes
Neoplasms
Pathologic Processes
 Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases