nderstanding problems with attention, memory and concentration in persons with multiple sclerosis
- Conditions
- Multiple Sclerosis (MS). And specifically cognitive problems in MS.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-002636-16-NL
- Lead Sponsor
- VU University medical center Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method