EUCTR2017-002636-16-NL
Active, not recruiting
Phase 1
Cognitive impairment and functional reorganization in multiple sclerosis: The role of GABA and glutamate - GABA and glutamate in cognitive impairment in MS
VU University medical center Amsterdam0 sitesAugust 9, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- VU University medical center Amsterdam
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To participate in the MRI part of the study:
- •\- Clinically definite Relapsing Remitting or Secondary Progressive Multiple sclerosis
- •\- Sufficient visual acuity and motor performance to perform the MRI task
- •\- Between 18 and 60 years of age
- •To participate in the PET\-part of the study:
- •\- Minimum hemoglobin values of 8 g/dl for men and 7 g/dl for women
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 75
Exclusion Criteria
- •For the MRI\-part of the study:
- •\- MR contraindications
- •\- Neurological and/or psychiatric disorders (other than MS)
- •\- For MS patients: the use of corticosteroids in the 4 weeks prior to inclusion.
- •For the PET\-part of the study:
- •\- benzodiazepine use or other drug use that affects the benzodiazepine receptor system (e.g. antipsychotics that show strong binding to GABAA receptors) 4 weeks or less before the start of the study.
- •\- In the case of pregnancy or breastfeeding
- •\- Insufficient haemoglobin value values as discussed in the inclusion criteria.
- •\- (a history of) significant cardiac disease
- •\- exposure to previous radiation leading to an annual cumulative dose of more than 10mSv
Outcomes
Primary Outcomes
Not specified
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