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Changes in Cerebral Blood Flow With Spinal Manipulative Therapy vs. Voluntary Motion

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Canadian Memorial Chiropractic College.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205490
First Posted: September 20, 2010
Last Update Posted: June 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Medical Protective Association
NCMIC
Information provided by:
Canadian Memorial Chiropractic College
  Purpose
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.

Condition Intervention
Vertebral Artery Dissection Cerebrovascular Accident Cerebrovascular Stroke Other: head positions and spinal manipulation

Study Type: Interventional
Study Design: Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Changes in Cerebral Blood Flow With Spinal Manipulative Therapy vs. Voluntary Motion

Further study details as provided by Canadian Memorial Chiropractic College:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: July 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: head positions and spinal manipulation
    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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion/Exclusion Criteria

  1. Enrolled and matriculated as a student in the Canadian Memorial Chiropractic College.
  2. 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.
  3. Sufficient English language ability to complete study questionnaires (see appendix).
  4. No history of disabling neck, arm or headache pain within the last 6 months.
  5. 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.
  6. Subjects will have had no prior history of head trauma or prior history of surgery to the neck region.
  7. No history of claustrophobia, metallic implants or tattoos to ensure compatibility with MRI requirements.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205490


Contacts
Contact: Jairus J Quesnele, BSc, DC 647 261 2760 jquesnele@gmail.com
Contact: Greg Wells, PhD 416-710-4618 greg.wells@utoronto.ca

Locations
Canada, Ontario
St. Joseph Healthcare, Research Imaging Institute Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Michael Noseworthy, PhD       nosewor@mcmaster.ca   
Contact: Greg Wells, PhD       greg.wells@utoronto.ca   
Principal Investigator: Greg Wells, PhD         
Sponsors and Collaborators
Canadian Memorial Chiropractic College
Canadian Medical Protective Association
NCMIC
Investigators
Principal Investigator: Greg Wells, PhD University of Toronto
Principal Investigator: Jairus Quesnele, BSc, DC Canadian Memorial Chiropractic College
Study Chair: John J Triano, DC, PhD Canadian Memorial Chiropractic College
Study Director: Michael Noseworthy, PhD McMaster University
  More Information

Publications:

Responsible Party: Greg Wells, University of Toronto
ClinicalTrials.gov Identifier: NCT01205490     History of Changes
Other Study ID Numbers: 102026
First Submitted: September 17, 2010
First Posted: September 20, 2010
Last Update Posted: June 28, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Stroke
Aneurysm, Dissecting
Vertebral Artery Dissection
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aneurysm
Cerebrovascular Trauma
Trauma, Nervous System
Wounds and Injuries