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Completed

NCT Number: NCT02567318

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

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.

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Key information

Conditions

Pain Healthy Volunteers Hyperalgesia Magnetic Resonance Imaging Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Secondary Hyperalgesia Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI-scan

Device

Magnetic resonance imaging scan of the brain

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2015
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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