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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02567318
• Date of registration: 01/10/2015
• Prospective Registration: Yes
• Primary sponsor: Rigshospitalet, Denmark
• Public title: Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?
• Scientific title: Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - A Study of Healthy Volunteers
• Date of first enrolment: October 2015
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02567318
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Denmark

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Secondary Hyperalgesia

Magnetic Resonance Imaging

Healthy Volunteers

Pain

Intervention(s)

Device: MRI-scan

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Secondary ID(s)

SM3-MSH-2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Copenhagen

Copenhagen Trial Unit, Center for Clinical Intervention Research