Pulse Width 0.15ms vs 0.30ms in Electroconvulsive Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2024-01-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Blue

1. Session - Titration with 0.30ms pulse width
2. Session - Titration with 0.15ms pulse width
3. Session and further - continue with 0.15ms pulse width

Group Type ACTIVE_COMPARATOR

Electroconvulsive therapy

Intervention Type DEVICE

Patients are treated with ECT.

Red

1. Session - Titration with 0.15ms pulse width
2. Session - Titration with 0.3ms pulse width
3. Session and further - continue with 0.3ms pulse width

Group Type ACTIVE_COMPARATOR

Electroconvulsive therapy

Intervention Type DEVICE

Patients are treated with ECT.

Interventions

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Electroconvulsive therapy

Patients are treated with ECT.

Intervention Type DEVICE

Eligibility Criteria

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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