arteriovenous malformation vessel malformation of the brain
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: AVM patients with age between 18 and 55 years, considered eligible for endovascular treatment, with cerebral AVMs confined to a single hemisphere (the non-affected hemisphere will be used to assess within-patient control values of hemodynamic and quantitative MR parameters). Informed consent will be obtained from all patients. Control subjects will be matched to patients according to age and intelligence level. Inclusion criteria for control subjects: 1. healthy male or female subject with age between 18 and 55 years. 2. voluntary participation 3. having given their written informed consent 4. willing to accept use of all anonymized data, including publication, and the confidential use and storage of all data
Exclusion criteria
Exclusion criteria: Patients will be excluded from the investigation if they 1. manifest dural or multiple AVMs; 2. present with intracerebral haematomas, since the presence of intracerebral hematoma may interfere with preoperative neuropsychological testing. Further, resorption of the haematoma probably affects neurocognitive function (and distinction of this effect from treatment effect will pose problems, if possible at all). 3. suffer from any other central nervous system anomaly; 4. have a medical history of chronic drug or alcohol abuse. Exclusion criteria for control subjects: 1. having a current brain or vascular disease 2. claustrophobia 3. having metal implants or metal objects on the body which cannot be removed 4. mental of physical status that is incompatible with the proper conduct of the study 5. being under medication that may affect neurocognitive function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters are: - Cambridge Cognitive Examination (CAMCOG) total score controlled for mood/neuropsychiatric status (to evaluate global cognitive functioning), - cerebral blood volume, cerebral blood flow, mean transit time (to evaluate brain perfusion/vascular steal), - quantitative MR parameters (e.g. T1 and T2 relaxation times) (to evaluate structural abnormalities in brain parenchyma) - correlation between (changes in) neurocognitive functioning, (changes in) brain perfusion and (changes in) quantitative MR parameters, before and after endovascular treatment. - predictive value of pre-operative perfusion and quantitative MR parameters with regard to treatment effect on neurocognitive funtion in patiens | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters are: - Obliteration rate of the AVM after endovascular treatment. | — |
Countries
Netherlands