Measuring Blood Flow in the Brain After Epileptic Activity (SYNAPSE)
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|ClinicalTrials.gov Identifier: NCT04028596|
Recruitment Status : Not yet recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Depression Postictal Delirium Electroconvulsive Therapy||Drug: Paracetamol Drug: Nimotop||Phase 2|
Postictal phenomena, such as sensory, motor or memory deficits, headache, delirium, and psychosis, are common manifestations after electroconvulsive therapy (ECT) induced seizures. Also, postictal phenomena add to the burden of seizures in patients with epilepsy. The pathophysiology of these phenomena is poorly understood and effective treatments are not available (Fisher RS, 2000; Krauss & Theodore, 2010). Recently, seizure-induced postictal vasoconstriction with cerebral hypoperfusion was observed in experimentally induced seizures in rats. Treatment with acetaminophen or calcium antagonists decreased hypoperfusion and postictal phenomena (Farrell, 2016, 2017).
The objective of this research is to study the effect of acetaminophen and nimodipine to reduce postictal phenomena after ECT induced seizures.
A prospective, three conditions crossover trial will be conducted, with randomized condition allocation, open-label treatment, and blinded end-point evaluation (PROBE design; Hansson, Hedner, & Dahlof, 1992).
Thirty-three adult (age >17 years) patients referred to treatment with ECT for a depressive episode will be included to achieve a statistical power of .80. This will be feasible in one year.
A single dose of nimodipine (60 mg) or acetaminophen (1000 mg) or no additional treatment will be given prior to a maximum of 12 ECT-sessions per patient. Patients will be randomly assigned to predefined treatment sequences. EEG and MRI measures will serve as main outcome measures, as well as psychometric tests.
Data will be stored on two separate hard disks, one including patient sensitive information for identification, the other with anonymized data only (for the sponsor).
Patients will be recruited by doctors at Rijnstate Hospital Arnhem. A mixed model with repeated measurements analysis will be conducted for the primary outcome measures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||This study makes use of a 3 x 3 crossover design, in which patients receive a randomized sequence of interventions in pairs of 3 (acetaminophen, nimodipine, no intervention), with a maximum of 12 interventions/measurements.|
|Masking Description:||The PROBE design will be used in this study, in which the principal investigator will be blinded to the administration of drugs until the end of the study. The other principal investigator will know about administration, but will not be involved in testing patients.|
|Official Title:||StudY of Effect of Nimodipine and Acetaminophen on Postictal Symptoms After ECT|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Active Comparator: Acetaminophen
Trade name: Paracetamol Pharmaceutical form: Tablet (oral use) Once 1000 mg 2h before the ECT-session. Total maximum of five times over the course of weeks
once, 1000mg, 2 h before ECT session
Other Name: RVG 107336
Active Comparator: Nimodipine
Trade name: Nimotop Pharmaceutical form: Film-coated tablet (oral use) Once 60mg 2h before the ECT-session. Total maximum of five times over the course of weeks.
once, 60mg, 2 h before ECT session
Other Name: RVG 12060
No Intervention: Control
Glass of water (50cc) only. Once 2h before the ECT-session. Total maximum of five times over the course of weeks.
- Time to EEG normalization [ Time Frame: Change from ictal to baseline EEG activity, up to 12 times per patient (across 6 weeks) ]quantitative metric of EEG background evolution over time, in seconds (will be assessed at baseline, during electroconvulsive therapy, and immediately afterwards for approximately 1 hour)
- Postictal reorientation time (by Sobin, 1995) [ Time Frame: in the first hour after electroconvulsive therapy (once per intervention), up to 12 times per patient (across 6 weeks) ]Five questions regarding reorientation will be asked in an interval of 5 minutes after electronvulsive shock therapy has ended. If the patient can answer 4 out of the 5 questions correctly, this is determined as the final score (in minutes). The scale ranges from 5 to 100 minutes. These scores indicate the time frame a patient needs until he/she is fully conscious and reoriented. Higher values indicate that a patients needs more time to regain reorientation.
- Structural MRI [ Time Frame: in the first hour after electroconvulsive therapy (once per intervention, in total 3 times per participant), lasts approx. 5 min. ]Isovoxel T1-weighted data (to make volumetric changes); is part of the MRI sequence (takes in total approximately 25 minutes)
- Arterial Spin Labeling MRI [ Time Frame: in the first hour after electroconvulsive therapy (once per intervention, in total 3 times per participant), lasts approx. 7 min. ]measures cerebral perfusion levels
- Resting state functional MRI [ Time Frame: in the first hour after electroconvulsive therapy (once per intervention, in total 3 times per participant), lasts approx. 5 min. ]used for brain mapping, measures functional organization (and connectivity) of certain brain areas
- Magnetic resonance angiography [ Time Frame: in the first hour after electroconvulsive therapy (once per intervention, in total 3 times per participant), lasts approx. 5 min. ]measures the vessel diameter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028596
|Contact: Joey Verdijk, MD||0031 email@example.com|
|Contact: Julia Pottkämper, Msc||0031 firstname.lastname@example.org|
|Principal Investigator:||Michel van Putten, MD||University of Twente|