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

Overview

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.

Full Title of Study: “Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? – A Study of Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2015

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 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.
    • 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.
  • 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).
  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Collaborator
    • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Provider of Information About this Clinical Study
    • Principal Investigator: Morten Sejer Hansen, M.D. – Rigshospitalet, Denmark

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