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Clinical Trials/EUCTR2017-002636-16-NL
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.

Registry
who.int
Start Date
August 9, 2017
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
VU University medical center Amsterdam

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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