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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02481882 |
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Date of registration:
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19/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Baseline Cortical Haemodynamics in MS
CortHaem |
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Scientific title:
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Investigating Baseline Cortical Haemodynamics in Multiple Sclerosis |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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80 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02481882 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Nikos Evangelou, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine & Health Sciences |
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Name:
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Nikos Evangelou |
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Address:
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Telephone:
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0115 9709735 |
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Email:
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nikos.evangelou@nottingham.ac.uk |
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Affiliation:
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Name:
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Nikos Evangelou, Ph.D. |
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Address:
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Telephone:
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0115 970 9735 |
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Email:
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nikos.evangelou@nottingham.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria (Healthy Volunteers):
- 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.
Inclusion Criteria (Patients):
- 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.
Exclusion Criteria:
- 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.
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Device: Magnetic Resonance Imaging
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Drug: Prohance (Gadoteridol)
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Primary Outcome(s)
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Cerebral Blood Flow
[Time Frame: 1 hour]
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Secondary Outcome(s)
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Arterial Cerebral Blood Volume
[Time Frame: 1 hour]
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Arterial Transit Time
[Time Frame: 1 hour]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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