PainNCT02567318
Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?
A study testing MRI-scan in people with Pain and Secondary Hyperalgesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Secondary Hyperalgesia, Healthy Volunteers
- What is being tested?
- MRI-scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - A Study of Healthy Volunteers
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.
Read the 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.
- Being tested
- MRI-scan
- Keywords
- Pain, Secondary hyperalgesia, Healthy volunteers, Magnetic Resonance Imaging
- Medical subject headings
- Pain, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-scanDevice
Magnetic resonance imaging scan of the brain
| Study group | Role | What they receive |
|---|---|---|
| MRI-scan | Experimental | All study participants will complete a MRI-scan of the brain Receives: Device: MRI-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 40 minutes
White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2
By Diffusion Tensor Imaging to investigate the association between area of secondary hyperalgesia and white matter microstructure using tract based spatial statistics (TBSS).
Measured: 40 minutes
White matter microstructure, evaluated by tract based spatial statistics, and size of the area area of secondary hyperalgesia, evaluated by cm2
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)
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen
- Responsible party
- Principal investigator, Morten Sejer Hansen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567318
- Sponsor's protocol ID
- SM3-MSH-2015
- Status last verified
- Dec 2016
- First submitted
- 1 Oct 2015
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27317630
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - A Study of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02567318
- Acronym / sponsor ID
- SM3-MSH-2015
- Keywords
- Pain, Secondary hyperalgesia, Healthy volunteers, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-scan | Experimental | Device: MRI-scanAll study participants will complete a MRI-scan of the brain |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-scanMagnetic resonance imaging scan of the brain | Device | MRI-scan |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Derived from this study: PubMed 27317630Hansen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-scan in people with Pain and Secondary Hyperalgesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.