Vertebral Artery DissectionNCT01205490
Changes in Cerebral Blood Flow With Spinal Manipulative Therapy vs. Voluntary Motion
A study testing head positions and spinal manipulation in people with Vertebral Artery Dissection and Cerebrovascular Accident, run by Canadian Memorial Chiropractic College at 1 site in Canada.
Trial summary
The investigators are performing a study to determine whether changes in blood flow occur in the neck and back of the brain following a series of head positions and a manipulation of the upper neck. 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
- Vertebral Artery Dissection, Cerebrovascular Accident, Cerebrovascular Stroke
- What is being tested?
- head positions and spinal manipulation
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Aug 2012
- 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
- Enrolled and matriculated as a student in the Canadian Memorial Chiropractic College.
- Healthy asymptomatic male patients who would otherwise receive cervical manipulation on a regular basis as a part of their normal learning experience and will have had a cervical manipulation in the last 3 months.
- Sufficient English language ability to complete study questionnaires (see appendix).
- No history of disabling neck, arm or headache pain within the last 6 months.
- No current or prior history of neurological symptoms including, facial or extremity weakness, abnormal sensation to the face, body or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing.
- Subjects will have had no prior history of head trauma or prior history of surgery to the neck region.
- No history of claustrophobia, metallic implants or tattoos to ensure compatibility with MRI requirements.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph Healthcare, Research Imaging Institute
Hamilton, Ontario, L8N 4A6
Michael Noseworthy, PhD, nosewor@mcmaster.ca
Greg Wells, PhD, greg.wells@utoronto.ca
About this study
The investigators are performing a study to determine whether changes in blood flow occur in the neck and back of the brain following a series of head positions and a manipulation of the upper neck. Each participant will be asked to undergo a series of MRI's to evaluate whether there are any changes in blood flow resulting from any of the head positions or manipulation. The study will be conducted over a period of 1 day and each participant can anticipate the testing to take approximately 120 minutes.
Read the detailed description
The goal is to further investigate the cerebrovascular hemodynamic consequences of cervical spine positions, including rotation and manipulation in-vivo under clinically relevant circumstances using two advanced forms of MRI technology on the VA and posterior cerebral vessels. According to the knowledge of the investigators, a study utilizing MRI and functional blood oxygen level dependent (fBOLD) imaging to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these vessels has yet to be conducted.
- Being tested
- head positions and spinal manipulation
- Medical subject headings
- Vertebral Artery Dissection, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head positions and spinal manipulationOther
Each subject will then undergo a baseline MRI in a head neutral position (0 degrees rotation). They will then be placed in head rotation (45 degrees) to the non-dominant and undergo a MRI. Maximum rotation to the side with MRI will follow. Finally, each subject will receive an upper cervical rotary manipulation to the non-dominant side with MRI immediately after. A total of 4 test conditions will be evaluated (rest, 45 degree, maximal, post-manipulation). The manipulation will be performed by an experience practitioner on a bed just outside the MRI room in supine position. A controlled impulse load will be applied and the head/neck returned to neutral position. Prior to each maneuver, the subject will be queried on their comfort, condition and willingness to continue
What is being measured
The primary outcome is the main question the study is designed to answer.
change in advanced magnetic resonance imaging
A change in vertebral, posterior cerebellar and collateral arterial blood flow associated with various head positions and an upper cervical manipulation will be measured using blood oxygen level dependent (BOLD). A BOLD MRI generates a signal by tracking changes in the local oxyhemoglobin to deoxyhemoglobin ratio. Signal changes are due to a combination of altered microvascular perfusion, blood volume, and fluctuations in cellular metabolism. It will also provide more sensitivity in determining the impact of changes in blood flow during the various head positions.
Measured: immediately after head positions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startJul 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Vertebral Artery DissectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Medical Protective Association, NCMIC
- Investigators
- Greg Wells, PhD, Principal investigator, University of TorontoJairus Quesnele, BSc, DC, Principal investigator, Canadian Memorial Chiropractic CollegeJohn J Triano, DC, PhD, Study chair, Canadian Memorial Chiropractic CollegeMichael Noseworthy, PhD, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205490
- Sponsor's protocol ID
- 102026
- Status last verified
- Jun 2011
- First submitted
- 17 Sep 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
Publications
Boyle E, Cote P, Grier AR, Cassidy JD. Examining vertebrobasilar artery stroke in two Canadian provinces. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S194-200. doi: 10.1016/j.jmpt.2008.11.019.
PubMed 19251064Cassidy JD, Boyle E, Cote P, He Y, Hogg-Johnson S, Silver FL, Bondy SJ. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and case-crossover study. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S201-8. doi: 10.1016/j.jmpt.2008.11.020.
PubMed 19251066Rubinstein SM, Peerdeman SM, van Tulder MW, Riphagen I, Haldeman S. A systematic review of the risk factors for cervical artery dissection. Stroke. 2005 Jul;36(7):1575-80. doi: 10.1161/01.STR.0000169919.73219.30. Epub 2005 Jun 2.
PubMed 15933263Zaina C, Grant R, Johnson C, Dansie B, Taylor J, Spyropolous P. The effect of cervical rotation on blood flow in the contralateral vertebral artery. Man Ther. 2003 May;8(2):103-9. doi: 10.1016/s1356-689x(02)00155-8.
PubMed 12890438Cagnie B, Jacobs F, Barbaix E, Vinck E, Dierckx R, Cambier D. Changes in cerebellar blood flow after manipulation of the cervical spine using Technetium 99m-ethyl cysteinate dimer. J Manipulative Physiol Ther. 2005 Feb;28(2):103-7. doi: 10.1016/j.jmpt.2005.01.005.
PubMed 15800509Mitchell JA. Changes in vertebral artery blood flow following normal rotation of the cervical spine. J Manipulative Physiol Ther. 2003 Jul-Aug;26(6):347-51. doi: 10.1016/S0161-4754(03)00074-5.
PubMed 12902962Johnson C, Grant R, Dansie B, Taylor J, Spyropolous P. Measurement of blood flow in the vertebral artery using colour duplex Doppler ultrasound: establishment of the reliability of selected parameters. Man Ther. 2000 Feb;5(1):21-9. doi: 10.1054/math.1999.0227.
PubMed 10688956Sakaguchi M, Kitagawa K, Hougaku H, Hashimoto H, Nagai Y, Yamagami H, Ohtsuki T, Oku N, Hashikawa K, Matsushita K, Matsumoto M, Hori M. Mechanical compression of the extracranial vertebral artery during neck rotation. Neurology. 2003 Sep 23;61(6):845-7. doi: 10.1212/01.wnl.0000078081.12097.ae.
PubMed 14504337Haynes MJ. Doppler studies comparing the effects of cervical rotation and lateral flexion on vertebral artery blood flow. J Manipulative Physiol Ther. 1996 Jul-Aug;19(6):378-84.
PubMed 8864968Licht PB, Christensen HW, Hojgaard P, Hoilund-Carlsen PF. Triplex ultrasound of vertebral artery flow during cervical rotation. J Manipulative Physiol Ther. 1998 Jan;21(1):27-31.
PubMed 9467098Licht PB, Christensen HW, Svendensen P, Hoilund-Carlsen PF. Vertebral artery flow and cervical manipulation: an experimental study. J Manipulative Physiol Ther. 1999 Sep;22(7):431-5. doi: 10.1016/s0161-4754(99)70030-8.
PubMed 10519558Bendick PJ, Jackson VP. Evaluation of the vertebral arteries with duplex sonography. J Vasc Surg. 1986 Mar;3(3):523-30. doi: 10.1067/mva.1986.avs0030523.
PubMed 3512861
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Blood Flow With Spinal Manipulative Therapy vs. Voluntary Motion
- ClinicalTrials.gov ID
- NCT01205490
- Acronym / sponsor ID
- 102026
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Collaborators
- Canadian Medical Protective Association, NCMIC
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 20 Sep 2010 (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 investigators are performing a study to determine whether changes in blood flow occur in the neck and back of the brain following a series of head positions and a manipulation of the upper neck. Each participant will be asked to undergo a series of MRI's to evaluate whether there are any changes in blood flow resulting from any of the head positions or manipulation. The study will be conducted over a period of 1 day and each participant can anticipate the testing to take approximately 120 minutes.
Detailed description
The goal is to further investigate the cerebrovascular hemodynamic consequences of cervical spine positions, including rotation and manipulation in-vivo under clinically relevant circumstances using two advanced forms of MRI technology on the VA and posterior cerebral vessels. According to the knowledge of the investigators, a study utilizing MRI and functional blood oxygen level dependent (fBOLD) imaging to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these vessels has yet to be conducted.
Study design
- Primary purpose
- Basic science
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Enrolled and matriculated as a student in the Canadian Memorial Chiropractic College.
- Healthy asymptomatic male patients who would otherwise receive cervical manipulation on a regular basis as a part of their normal learning experience and will have had a cervical manipulation in the last 3 months.
- Sufficient English language ability to complete study questionnaires (see appendix).
- No history of disabling neck, arm or headache pain within the last 6 months.
- No current or prior history of neurological symptoms including, facial or extremity weakness, abnormal sensation to the face, body or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| head positions and spinal manipulationEach subject will then undergo a baseline MRI in a head neutral position (0 degrees rotation). They will then be placed in head rotation (45 degrees) to the non-dominant and undergo a MRI. Maximum rotation to the side with MRI will follow. Finally, each subject will receive an upper cervical rotary manipulation to the non-dominant side with MRI immediately after. A total of 4 test conditions will be evaluated (rest, 45 degree, maximal, post-manipulation). The manipulation will be performed by an experience practitioner on a bed just outside the MRI room in supine position. A controlled impulse load will be applied and the head/neck returned to neutral position. Prior to each maneuver, the subject will be queried on their comfort, condition and willingness to continue | Other | – |
Primary outcome
change in advanced magnetic resonance imaging
Time frame: immediately after head positions.
A change in vertebral, posterior cerebellar and collateral arterial blood flow associated with various head positions and an upper cervical manipulation will be measured using blood oxygen level dependent (BOLD). A BOLD MRI generates a signal by tracking changes in the local oxyhemoglobin to deoxyhemoglobin ratio. Signal changes are due to a combination of altered microvascular perfusion, blood volume, and fluctuations in cellular metabolism. It will also provide more sensitivity in determining the impact of changes in blood flow during the various head positions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Background: PubMed 19251064Boyle E, Cote P, Grier AR, Cassidy JD. Examining vertebrobasilar artery stroke in two Canadian provinces. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S194-200. doi: 10.1016/j.jmpt.2008.11.019.
- Background: PubMed 19251066Cassidy JD, Boyle E, Cote P, He Y, Hogg-Johnson S, Silver FL, Bondy SJ. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and case-crossover study. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S201-8. doi: 10.1016/j.jmpt.2008.11.020.
- Background: PubMed 15933263Rubinstein SM, Peerdeman SM, van Tulder MW, Riphagen I, Haldeman S. A systematic review of the risk factors for cervical artery dissection. Stroke. 2005 Jul;36(7):1575-80. doi: 10.1161/01.STR.0000169919.73219.30. Epub 2005 Jun 2.
- Background: PubMed 12890438Zaina C, Grant R, Johnson C, Dansie B, Taylor J, Spyropolous P. The effect of cervical rotation on blood flow in the contralateral vertebral artery. Man Ther. 2003 May;8(2):103-9. doi: 10.1016/s1356-689x(02)00155-8.
- Background: PubMed 15800509Cagnie B, Jacobs F, Barbaix E, Vinck E, Dierckx R, Cambier D. Changes in cerebellar blood flow after manipulation of the cervical spine using Technetium 99m-ethyl cysteinate dimer. J Manipulative Physiol Ther. 2005 Feb;28(2):103-7. doi: 10.1016/j.jmpt.2005.01.005.
- Background: PubMed 12902962Mitchell JA. Changes in vertebral artery blood flow following normal rotation of the cervical spine. J Manipulative Physiol Ther. 2003 Jul-Aug;26(6):347-51. doi: 10.1016/S0161-4754(03)00074-5.
- Background: PubMed 10688956Johnson C, Grant R, Dansie B, Taylor J, Spyropolous P. Measurement of blood flow in the vertebral artery using colour duplex Doppler ultrasound: establishment of the reliability of selected parameters. Man Ther. 2000 Feb;5(1):21-9. doi: 10.1054/math.1999.0227.
- Background: PubMed 14504337Sakaguchi M, Kitagawa K, Hougaku H, Hashimoto H, Nagai Y, Yamagami H, Ohtsuki T, Oku N, Hashikawa K, Matsushita K, Matsumoto M, Hori M. Mechanical compression of the extracranial vertebral artery during neck rotation. Neurology. 2003 Sep 23;61(6):845-7. doi: 10.1212/01.wnl.0000078081.12097.ae.
- Background: PubMed 8864968Haynes MJ. Doppler studies comparing the effects of cervical rotation and lateral flexion on vertebral artery blood flow. J Manipulative Physiol Ther. 1996 Jul-Aug;19(6):378-84.
- Background: PubMed 9467098Licht PB, Christensen HW, Hojgaard P, Hoilund-Carlsen PF. Triplex ultrasound of vertebral artery flow during cervical rotation. J Manipulative Physiol Ther. 1998 Jan;21(1):27-31.
- Background: PubMed 10519558Licht PB, Christensen HW, Svendensen P, Hoilund-Carlsen PF. Vertebral artery flow and cervical manipulation: an experimental study. J Manipulative Physiol Ther. 1999 Sep;22(7):431-5. doi: 10.1016/s0161-4754(99)70030-8.
- Background: PubMed 3512861Bendick PJ, Jackson VP. Evaluation of the vertebral arteries with duplex sonography. J Vasc Surg. 1986 Mar;3(3):523-30. doi: 10.1067/mva.1986.avs0030523.
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.
Greg Wells, PhD principal investigator
University of Toronto
Jairus Quesnele, BSc, DC principal investigator
Canadian Memorial Chiropractic College
John J Triano, DC, PhD study chair
Canadian Memorial Chiropractic College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing head positions and spinal manipulation in people with Vertebral Artery Dissection and Cerebrovascular Accident, run by Canadian Memorial Chiropractic College at 1 site in Canada.
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 7 inclusion and 0 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 28 Jun 2011. 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 Canada. 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 Jairus J Quesnele, BSc, DC (647 261 2760, jquesnele@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in advanced magnetic resonance imaging (time frame: immediately after head positions.). 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 NCT01205490, which also lists 12 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 28 Jun 2011.