Baseline Cortical Haemodynamics in MS
CortHaem
Investigating Baseline Cortical Haemodynamics in Multiple Sclerosis
1 other identifier
interventional
80
1 country
1
Brief Summary
This study will provide information on cortical haemodynamics in MS patients to address the discrepancies reported in previous literature, allowing further insight into the role of haemodynamics in the disease. It will also instruct us as to the most effective scanning protocols for future research. Developing a suitable protocol for studying perfusion longitudinally may also enable identification of new therapeutic interventions to normalise any perfusion abnormalities in MS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Jan 2017
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedOctober 12, 2018
October 1, 2018
2.7 years
May 19, 2015
October 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Cerebral Blood Flow
A short MRI scan is able to quantify the amount of blood perfusion into brain tissue (to be performed with and without the gadolinium contrast agent).
1 hour
Secondary Outcomes (2)
Arterial Cerebral Blood Volume
1 hour
Arterial Transit Time
1 hour
Study Arms (2)
Healthy Volunteers
OTHERHealthy Volunteers will undergo an Magnetic Resonance Imaging scan.
MS Patients
OTHERPatients will undergo and Magnetic Resonance Imaging scan including the use of Prohance (Gadoteridol).
Interventions
All scanning will be performed using a 7 Tesla Philips Achieva scanner with multi-transit capability (Philips Medical Systems, Best, The Netherlands). The volunteers will be scanned with a 32-channel receive coil.
A gadolinium based liquid administered intravenously in order to quantify blood flow in the brain using an MR scanner.
Eligibility Criteria
You may qualify if:
- Male or female volunteers who are between the ages of 21 and 80.
- Able to give voluntary written informed consent to participate in the study.
- Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures.
- Diagnosed with Multiple Sclerosis.
- Male or female volunteers who are between the ages of 21 and 80.
- Able to give voluntary written informed consent to participate in the study.
- Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures.
You may not qualify if:
- Any history of neurological illness other than MS.
- Known hypersensitivity to any MR or X-Ray contrast agent.
- Any history of renal failure or disease.
- Any history of allergies.
- Any history of circulation problems (vascular disease).
- Pregnancy or breastfeeding.
- MRI contraindications as screened on safety questionnaire (e.g. metal implants or pacemaker).
- Have taken part in any other clinical study within the previous 3 months.#
- Any contraindications provided from MRI or contrast agent safety forms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen's Medical Centre
Nottingham, Nottinghamshire, NG7 2RD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikos Evangelou, Ph.D.
Faculty of Medicine & Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2015
First Posted
June 25, 2015
Study Start
January 1, 2017
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
October 12, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share