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

NCT02567318 | Completed DMC

• 1 other identifier: SM3-MSH-2015
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Secondary Hyperalgesia; Healthy Volunteers; Magnetic Resonance Imaging

Keywords

Pain; Secondary hyperalgesia; Healthy volunteers; Magnetic Resonance Imaging

Outcome Measures

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.

  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

Secondary Outcomes (3)

• 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

• White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2

  40 minutes

• White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2

  40 minutes

Other Outcomes (9)

• Volume of the nucleus caudatus, evaluated by mm3, and heat pain detection threshold, registered by degrees celsius.

  40 minutes

• 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

• 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

Study Arms (1)

MRI-scan

EXPERIMENTAL

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

Device: MRI-scan

Interventions

MRI-scan DEVICE

Magnetic resonance imaging scan of the brain

MRI-scan

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Hansen MS, Asghar MS, Wetterslev J, Pipper CB, Johan Martensson J, Becerra L, Christensen A, Nybing JD, Havsteen I, Boesen M, Dahl JB. Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - Protocol for a 3-Tesla MRI Study of Healthy Volunteers. JMIR Res Protoc. 2016 Jun 17;5(2):e117. doi: 10.2196/resprot.5680.

  PMID: 27317630 DERIVED

MeSH Terms

Conditions

Pain; Hyperalgesia

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 2, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

DK (1)