Epilepsy Electroconvulsive therapy Postictal state Acetaminophen Nimodipine Hypoperfusion Epilepsie Elektroconvulsietherapie Postictale fase Paracetamol Nimodipine Hypoperfusie
Conditions
Interventions
A single dose of nimodipine (60 mg) or acetaminophen (1000 mg) or no additional treatment will be given prior to each ECT-session. Patients will be randomly assigned to predefined treatment sequences.
Sponsors
University of Twente, Enschede; Rijnstate Hospital, Arnhem
Eligibility
Inclusion criteria
Inclusion criteria: Adulthood (age > 17 years); Current clinical diagnosis of depressive episode (unipolar, bipolar, schizoaffective); Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.
Exclusion criteria
Exclusion criteria: Known adverse reactions to acetaminophen or nimodipine. In that case participants can still be included into the other intervention groups; Chronic use of acetaminophen, calcium-antagonists or NSAID’s that cannot be interrupted for less than two days before the ECT-session.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be ‘time to EEG normalization’, defined as the time interval between seizure onset and return to the pre-ECT (baseline) EEG, quantified with the temporal Brain Symmetry Index. This is a well-defined, robust and generally accepted quantitative metric of EEG background evolution over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical measures o ‘Orientation recovery time’, defined as the time-interval between seizure onset and orientation in time, person, and place. Orientation recovery time will be tested at the bedside by the Reorientation Time list (ROT) every five minutes. This measure has shown to be a good discriminator in studies on ECT settings and a good predictor of long-term memory deficits. o The incidence and severity of headache, nausea and myalgia as measured using a visual analogue scale. The inquiry will be performed at the first moment of full orientation, as measured by the ROT. • EEG measures o The alpha/delta ratio derived from the EEG as a function of time after ECT. This ratio will be fitted to a sigmoid function, allowing to extract the ‘postictal recovery time constant (PRTC)’. o The cerebral recovery index (CRI) which is based on the evolution of several qEEG features over time and showed good discrimination between patients with good and poor recovery after global cerebral ischemia. • MRI measures within one hour after seizure termination. Patients will undergo one MRI scan per condition. Regions of interest in cortex, cerebellum, white matter and hippocampus will be analyzed. We will use the following MRI sequences to answer our secondary research questions: o Cerebral perfusion: MRI with Arterial Spin Labeling (pCASL sequence on 3T Philips scanner) will be used measure perfusion levels; o Vessel diameter as measured with MRA; o Resting state activity and functional connectivity as measured by BOLD fMRI; o Structural MRI will be collected using isovoxel T1-weighted data to make volumetric changes during the ECT-course possible. | — |
Contacts
Public ContactJulia Pottkämper
University of Twente/ Rijnstate Hospital
Outcome results
None listed