High-field (7T) MRI biomarkers for neurocognitive impairment in MELAS and the role of diabetes.

Recruiting

Conditions: brain structure
cognition
10027424
10018424

Registration Number: NL-OMON41572

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

General:
Subjects aged 18 to 45 and subjects gave written informed consent.;MELAS patients:
Confirmed carrier of the m.3243A>G mutation and mild MELAS phenotype (fatique, myopathy, mild exercise intolerance).;Diabetes type 2:
Fasting blood glucose >= 7.0 mmol/l and/or used oral glucose-lowering medication or insulin.;Age, gender and level of education matched controls:
Those that do not carry the m.3243A>G, the age, gender and level of eduction of the group of healthy controls should not differ significantly from the age of the group of patients

Exclusion Criteria

All groups:
Contra-indications for MRI examination: 1) pacemaker, 2) neurostimulator, 3) medication pump, 4) cochlear or hearing implant, 5) tattoos or other items that cannot be removed and include metal parts, 6) metal splinter in the eye, 7) pregnancy, 8) claustrophobia, 9) brain vessel clamps, 10) denture, which contains magnets, 11) operations in the past, where metal or synthetic material is used and still were in the body; psychiatric or other disorders likely to impact on informed consent; diabetes mellitus type 1 (DM1).;MELAS patients:
Other mitochondrial/neurological/psychiatric disease/syndrome other than MELAS. Severe phenotype (stroke-like lesions and severe exercise intolerance).;Age, gender and level of eduction matched controls:
Any mitochondrial/neurological/psychiatric disease/syndrome.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MRI Biomarkers of brain alterations, including:<br /><br>• Quantitative measures (T1/T2* relaxation times),<br /><br>• Cerebral blood flow (arterial spin labeling, ml blood/100 g tissue/min),<br /><br>• Functional characteristics (in resting state or during a task),</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cognitive functioning z-scores based on different domains:<br /><br>• Memory,<br /><br>• Mental speed,<br /><br>• Attention and executive functioning,<br /><br>• Visual and spatial abilities</p><br>