Measuring blood flow in the brain after epileptic activity

Phase 1

• Conditions: Postictal phenomena after electroconvulsive therapy (ECT) induced seizures.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-000617-37-NL
• Lead Sponsor: Rijnstate ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-25
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 33

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

Known adverse or allergic reactions to acetaminophen or nimodipine;

Chronic use of acetaminophen,calcium-antagonistsor NSAID’s that cannot be interrupted for less than two daysbefore the ECT-session;

Contraindications for magnetic resonance imaging (e.g. ferromagnetic implants, pacemakers).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does treatment with drugs modulating vasoconstriction, i.e. COX-inhibitors (acetaminophen) or calcium-antagonists (nimodipine), improve electrographic postictal phenomena?;<br> Secondary Objective: Does treatment with acetaminophen or nimodipine improve ‘time to orientation’?<br> Does treatment with paracetamol or nimodipine prevent or limit postictal hypoperfusion?<br> Are clinical and electrographic postictal phenomena associated with brain perfusion and function?<br> ;Primary end point(s): ‘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.;Timepoint(s) of evaluation of this end point: The primary endpoint is measured after each ECT-session.