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

NCT ID: NCT02567318

Last Updated: 2016-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Pain; Secondary Hyperalgesia; Healthy Volunteers; Magnetic Resonance Imaging

Keywords

Pain; Secondary hyperalgesia; Healthy volunteers; Magnetic Resonance Imaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

MRI-scan

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

Group Type: EXPERIMENTAL

MRI-scan

Intervention Type: DEVICE

Magnetic resonance imaging scan of the brain

Interventions

MRI-scan

Magnetic resonance imaging scan of the brain

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Morten Sejer Hansen

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 27317630 (View on PubMed)

Other Identifiers

SM3-MSH-2015

Identifier Type: -

Identifier Source: org_study_id