PWECT015: Pulse Width 0.15ms vs 0.30ms in Electroconvulsive Therapy

• Sponsor: Charles University, Czech Republic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05465915
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The PWECT015 study was designed to compare the application of 0.15ms and 0.30ms pulse width in electroconvulsive therapy (ECT). Subjects will be compared both within groups and in-group via psychometric scales.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder; Bipolar Depression	Device: Electroconvulsive therapy	Early Phase 1

Detailed Description

This study is a controlled randomized clinical trial. Patients (projected n=40 are randomized into two groups - blue (20) and red (20). Randomization will be blocked (size sample 4) - 1 allocator. ECT practitioners are aware which patient belongs to which group but are blinded to block size. Testers are blinded to what group the patients belong to and what ECT parameters are used. Patients and attending psychiatrists are also blinded as to which group the patient belongs to.

The MECTA SIGMA device will be used for ECT.

Cross-over titration by stimulation will be used during the application of ECT to find the seizure threshold (ST) as follows:

RED GROUP

1. Session - Titration with 0.15ms

2. Session - Titration with 0.3 ms

3. Session and further - continue with 0.3 ms pulse width and 6x ST found during the second session.

BLUE GROUP

1. Session - Titration with 0.30ms

2. Session - Titration with 0.15ms

3. Session and further - continue with 0.15ms pulse width and 6x ST found during the second session.

Delivered energy is measured in percentage (%) of the maximum charge (in millicoulombs, mC) that the European version of the MECTA SIGMA device is able to administer. Total amount of ECT applications is individual and based on the clinical state of the patient. ECT outcome will be predicted via seizure duration (SD). If the seizure duration is less than 15s, the ECT dosage will be increased during next session by 100%. Throughout the ECT course, patients will be closely monitored by the testers via psychometric scales.

Primary outcome of the study is measured via Time To Recovery (TTR) - which is measured after each ECT application. TTR is the time (in minutes) after which the patient is fully vigilant and aware of his surroundings after an ECT procedure. TTR will be compared both in-group and between groups. Other psychometric measures are specified in the outcome measures section.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Subjects are randomized into two groups (blue and red) where crossover titration of ECT is used. From the 3. application and onwards, subjects continue either with 0.15ms or 0.30ms pulse width.Subjects are randomized into two groups (blue and red) where crossover titration of ECT is used. From the 3. application and onwards, subjects continue either with 0.15ms or 0.30ms pulse width.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Blocked randomization is used to divide patients into blue and red group via an allocator. ECT practitioners are aware which patient belongs to which group but are blinded to block size. Testers, patients and attending psychiatrists are blinded to what group the patients belong to and what ECT parameters are used.
• Primary Purpose: Treatment
• Official Title: The Effect of 0.15ms Pulse Width on the Outcome of Electroconvulsive Therapy
• Actual Study Start Date: Jan 18, 2022
• Anticipated Primary Completion Date: Jul 18, 2023
• Anticipated Study Completion Date: Jan 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Blue Session - Titration with 0.30ms pulse width Session - Titration with 0.15ms pulse width Session and further - continue with 0.15ms pulse width	Device: Electroconvulsive therapy; Patients are treated with ECT.
Active Comparator: Red Session - Titration with 0.15ms pulse width Session - Titration with 0.3ms pulse width Session and further - continue with 0.3ms pulse width	Device: Electroconvulsive therapy; Patients are treated with ECT.

Outcome Measures

Primary Outcome Measures

1. Time to Recovery (TTR) [immediately after each ECT procedure, measured in minutes.]

   time to when the patient is fully vigilant and aware of his surroundings after an ECT procedure

2. ECCA (Electroconvulsive cognitive assesment) [T1: baseline, 2 days before the commencement of an ECT course, T2: during the course of ECT, between second and third ECT application, T3: after the course of ECT, within 2 days]

   cognitive screening optimized for measuring cognitive functions in patients before, during and after the course of ECT.

3. AMI (Autobiographical Memory Interview) [T1: baseline, 2 days before the commencement of an ECT course, T2: after the course of ECT, within 2 days , T3: 2 months after the ECT course , T4: 4 months after the ECT course, T5: 6 months after the ECT course]

   This interview is intended to quantify retrograde amnesia following electroconvulsive therapy (ECT).

4. MoCA (Montreal Cognitive Assessment) [T1: baseline, 2 days before the commencement of an ECT course, T2: 2 months after the ECT course, T3: 4 months after the ECT course, T4: 6 months after the ECT course]

   Screening of cognitive functions, results used as an inclusion criteria of the study and for the determination of the cognitive baseline.

5. QIDS (The Quick Inventory of Depressive Symptomatology) [T1: baseline, 2 days before the commencement of an ECT course, T2: during the course of ECT, between second and third ECT application, T3: after the course of ECT, within 2 days, T4: 2 months after ECT , T5: 4 months after ECT, T6: 6 months after ECT]

   Rates depression symptoms via self-assessment

6. MADRS (Montgomery-Asberg Depression Rating Scale) [T1: baseline, 2 days before the commencement of an ECT course, T2: during the course of ECT, between second and third ECT application, T3: after the course of ECT, within 2 days, T4: 2 months after ECT , T5: 4 months after ECT, T6: 6 months after ECT]

   Assessment of depression severity, objective scale based on clinicians interview with a patient, results also used as an inclusion criteria of the study.

7. BVMT-R (Brief Visuospatial Memory Test-Revised) [1: baseline, 2 days before the commencement of an ECT course, T2: after the course of ECT, within 2 days , T3: 2 months after the ECT course , T4: 4 months after the ECT course, T5: 6 months after the ECT course]

   Neuropsychological assessment designed to evaluate visuospatial memory in patients.

8. RAVLT (The Rey Auditory Verbal Learning Test) [1: baseline, 2 days before the commencement of an ECT course, T2: after the course of ECT, within 2 days , T3: 2 months after the ECT course , T4: 4 months after the ECT course, T5: 6 months after the ECT course]

   Neuropsychological assessment designed to evaluate verbal memory in patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age equal to 18 or higher

• score equal or higher than 20 on the Montgomery-Asberg Depression Scale (MADRS),

• major depressive disorder or bipolar depression

Exclusion Criteria:

• other axis 1 disorder

• ECT in the last 3 months

• neurological disease

• psychosis

• pregnancy

• any somatic condition that contraindicates ECT

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague	Prague	Czech Republic	Czechia	12000

Sponsors and Collaborators

• Charles University, Czech Republic

Investigators

• Principal Investigator: Jana Heidingerová, Department of Psychiatry, First Faculty of Medicine, Charles University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jozef Buday, Head of Neurostimulation Center, General University Hospital in Prague, Charles University, Czech Republic
• ClinicalTrials.gov Identifier: NCT05465915
• Other Study ID Numbers: 1885/20 S-IV
• First Posted: Jul 20, 2022
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Jozef Buday, Head of Neurostimulation Center, General University Hospital in Prague, Charles University, Czech Republic: Electroconvulsive Therapy, Depression, Pulse-Width
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder

Study Results

No Results Posted as of Jul 20, 2022