Measuring Blood Flow in the Brain After Epileptic Activity

  • STATUS
    Recruiting
  • End date
    Oct 24, 2021
  • participants needed
    33
  • sponsor
    Rijnstate Hospital
Updated on 24 January 2021
depressed mood
depressive episode
electroconvulsive therapy

Summary

In this clinical trial, postictal phenomena (i.e., headache, delirium) will be investigated after administration of acetaminophen and nimodipine in depressed patients receiving electroconvulsive therapy (ECT). Postictal phenomena are thought to result from decreased cerebral blood flow and decreased oxygen concentration in the brain. It is expected that acetaminophen and nimodipine will reduce these postictal phenomena, compared to no treatment, because they target these mechanisms.

Description

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.

Details
Condition Endogenous depression, Depression, Epilepsy, Electroconvulsive Therapy, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Depressed, Seizure Disorders (Pediatric), Seizure Disorders, Postictal Delirium, depressive disorder, depressed mood, miserable, electroconvulsive therapy (ect), depressive disorders, epileptic, seizure disorder, epilepsia, epileptics
Treatment Paracetamol, Nimotop, Nimotop
Clinical Study IdentifierNCT04028596
SponsorRijnstate Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Depression (Adolescent) or Depression (Treatment-Resistant) or Seizure Disorders or Endogenous depression or Electroconvulsive Therapy or Depression (...?
Do you have any of these conditions: depressed mood or Epilepsy or Seizure Disorders (Pediatric) or Depression (Pediatric) or miserable or seizure disorder or depressive disorder or Seizu...?
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

Known adverse or allergic reactions to acetaminophen or nimodipine
Chronic use of acetaminophen, calcium-antagonists or NSAID's that cannot be interrupted for less than two days before the ECT-session
Contraindications for magnetic resonance imaging (e.g. ferromagnetic implants, pacemakers, claustrophobia)
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