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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41572
Enrollment
52
Registered
2014-08-18
Start date
2015-01-13
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain structure cognition

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Cognitive functioning z-scores based on different domains: • Memory, • Mental speed, • Attention and executive functioning, • Visual and spatial abilities

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)