Chronic PainNCT02987933
The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions
An observational study of Chronic Pain, run by Brain Scan Inc. at 1 site in United States.
Trial summary
Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy normals and may be sufficiently different to allow a high level of classification accuracy of whether subjects have chronic pain. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jan 2018
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with daily chronic pain (> 6 months)
Who may be able to join
- Daily Pain lasting for more than 6 months. Ages eligible for study are between 20 and 70 years.
Who cannot join
- Adults unable to consent Children, teenagers Pregnant women Prisoners Subjects who do not know English MRI exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
WNY MRI
Buffalo, New York, 14203
David S Wack, Ph.D., 716-838-5889 ext. 152, dswack@buffalo.edu
About this study
Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy normals and may be sufficiently different to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals.
Read the detailed description
Resting state fMRI scans of chronic pain sufferers may be sufficiently different from scans of normal subjects to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals. The analysis will use pattern recognition methods in a leave N out cross validation design. The success of the classifications will be the mean of all the validation runs.
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, fMRI, DTI
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Pain | Adults, > 6 months duration, daily pain | |
| Healthy Normals | Age and gender matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain connectivity
Assessed by fMRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain Scan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- State University of New York at Buffalo
- Responsible party
- Sponsor
- Investigators
- David S Wack, Ph.D., Principal investigator, University at Buffalo: SUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987933
- Sponsor's protocol ID
- BSI001
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.
PubMed 20506181Kucyi A, Moayedi M, Weissman-Fogel I, Goldberg MB, Freeman BV, Tenenbaum HC, Davis KD. Enhanced medial prefrontal-default mode network functional connectivity in chronic pain and its association with pain rumination. J Neurosci. 2014 Mar 12;34(11):3969-75. doi: 10.1523/JNEUROSCI.5055-13.2014.
PubMed 24623774Baliki MN, Geha PY, Apkarian AV, Chialvo DR. Beyond feeling: chronic pain hurts the brain, disrupting the default-mode network dynamics. J Neurosci. 2008 Feb 6;28(6):1398-403. doi: 10.1523/JNEUROSCI.4123-07.2008.
PubMed 18256259Boeckle M, Schrimpf M, Liegl G, Pieh C. Neural correlates of somatoform disorders from a meta-analytic perspective on neuroimaging studies. Neuroimage Clin. 2016 Apr 10;11:606-613. doi: 10.1016/j.nicl.2016.04.001. eCollection 2016.
PubMed 27182487Tagliazucchi E, Balenzuela P, Fraiman D, Chialvo DR. Brain resting state is disrupted in chronic back pain patients. Neurosci Lett. 2010 Nov 12;485(1):26-31. doi: 10.1016/j.neulet.2010.08.053. Epub 2010 Aug 26.
PubMed 20800649
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions
- ClinicalTrials.gov ID
- NCT02987933
- Acronym / sponsor ID
- BSI001
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, fMRI, DTI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brain Scan Inc.Industry (pharma, biotech, devices)
- Collaborators
- State University of New York at Buffalo
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 9 Dec 2016 (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.
Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy normals and may be sufficiently different to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals.
Detailed description
Resting state fMRI scans of chronic pain sufferers may be sufficiently different from scans of normal subjects to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals. The analysis will use pattern recognition methods in a leave N out cross validation design. The success of the classifications will be the mean of all the validation runs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain | – | –Adults, > 6 months duration, daily pain |
| Healthy Normals | – | –Age and gender matched controls |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with daily chronic pain (> 6 months)
Key inclusion criteria (1 listed)
- Daily Pain lasting for more than 6 months. Ages eligible for study are between 20 and 70 years.
Key exclusion criteria (1 listed)
- Adults unable to consent Children, teenagers Pregnant women Prisoners Subjects who do not know English MRI exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional brain connectivity
Time frame: 6 months
Assessed by fMRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Background: PubMed 20506181Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.
- Background: PubMed 24623774Kucyi A, Moayedi M, Weissman-Fogel I, Goldberg MB, Freeman BV, Tenenbaum HC, Davis KD. Enhanced medial prefrontal-default mode network functional connectivity in chronic pain and its association with pain rumination. J Neurosci. 2014 Mar 12;34(11):3969-75. doi: 10.1523/JNEUROSCI.5055-13.2014.
- Background: PubMed 18256259Baliki MN, Geha PY, Apkarian AV, Chialvo DR. Beyond feeling: chronic pain hurts the brain, disrupting the default-mode network dynamics. J Neurosci. 2008 Feb 6;28(6):1398-403. doi: 10.1523/JNEUROSCI.4123-07.2008.
- Background: PubMed 27182487Boeckle M, Schrimpf M, Liegl G, Pieh C. Neural correlates of somatoform disorders from a meta-analytic perspective on neuroimaging studies. Neuroimage Clin. 2016 Apr 10;11:606-613. doi: 10.1016/j.nicl.2016.04.001. eCollection 2016.
- Background: PubMed 20800649Tagliazucchi E, Balenzuela P, Fraiman D, Chialvo DR. Brain resting state is disrupted in chronic back pain patients. Neurosci Lett. 2010 Nov 12;485(1):26-31. doi: 10.1016/j.neulet.2010.08.053. Epub 2010 Aug 26.
- Individual participant dataSharing planned: No
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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.
David S Wack, Ph.D. principal investigator
University at Buffalo: SUNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Brain Scan Inc. at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David S Wack, Ph.D. (716-838-5889 ext. 152, dswack@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional brain connectivity (time frame: 6 months). 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 NCT02987933, which also lists 5 linked publications.
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 9 Dec 2016.