In this study we would like to investigate whether cerebral perfusie and cerebral metabolism can be influenced with pharmacological agents in patients with MS and in healthy control persons. Cerebral perfusion and cerebral metabolism wil be measured…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The difference in measures of cerebral perfusion before and after use of the
trial medication in and between the groups of patients and healthy control
persons
- The difference in measures of cerebral metabolism (as measured with MR
spectroscopy) in and between the groups of patients and healthy control persons
Secondary outcome
none
Background summary
The pathogenesis of progression in MS is unknown. Our research group has
formulated the hypothesis that astrocytes play an important role in the
pathophysiology of progression in MS. According to our hypothesis, astrocytic
disfunction leads to a decreased energy supply to axons and to a disturbed
cerebral microperfusion. It is not known whether cerebral perfusion and
cerebral metabolism can be influenced with pharmacologic agents.
Study objective
In this study we would like to investigate whether cerebral perfusie and
cerebral metabolism can be influenced with pharmacological agents in patients
with MS and in healthy control persons. Cerebral perfusion and cerebral
metabolism wil be measured with special MRI techniques.
Study design
Exploratory case control study
Study burden and risks
Medium burden for patients:
Three visits to the research centre of 2-3 hours duration:
- first visit: neurologic exam and baseline scan
- second visit: post-clenbuterol scan
- third visit: post-cisapride scan
Hanseplein 1
9713GZ
NL
Hanseplein 1
9713GZ
NL
Listed location countries
Age
Inclusion criteria
1) a diagnosis of MS, according to the McDonald criteria with a secondary progressive disease course and a disease duration of between ten and fifteen years
2) age 18-60 years
3) informed consent
Exclusion criteria
1) use of systemic corticosteroids in the eight weeks before inclusion into the trial
2) use of immunomodulatory treatments for MS
3) a history of cerebral pathology other than MS (cerebral infarct, cerebral haemorrhage, Parkinson's disease, Alzheimer's disease, cerebral vasculitis, brain absces)
4) diabetes mellitus, cardiac arrhytmia, prolonged qt time on ecg, pregnancy or breast feeding.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-004318-42-NL |
| CCMO | NL13976.042.06 |