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Completed

NCT Number: NCT02928159

Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

This is hypothesized to increase stimulation focality, thus minimizing cognitive side effects compared to conventional ECT. The study will enroll 22 patients recruited from the Behman Hospital, Cairo, Egypt. Patients referred to ECT service in the Behman Hospital who are clinically indicated to do ECT for major depressive episode of a mood disorder or psychotic episode of a primary psychotic disorder will be approached. Eligible participants who signed informed consent will be included to receive a course of Right Unilateral Ultrabrief LAP-ST.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ECT clinically indicated
  • Males or females over 22 to 80 years of age
  • Use of effective method of birth control for women of child-bearing capacity
  • Patient is medically stable
  • Capacity of patient to fully participate in the informed consent process as evaluated by their clinician

Exclusion criteria

  • Current unstable or serious medical condition, or any co-morbid medical condition that substantially increases the risks of ECT
  • History of conditions that may make ECT unsafe such as metal in the head, or a skull defect
  • Female patients who are currently pregnant or plan to be pregnant during the study

Treatment and study plan

Mecta spectrum 5000Q device

Device

LAP-ST and Right Unilateral (RUL) electrode placement.

Primary outcomes

  1. Feasibility (by successfully inducing therapeutic seizures during LAP-ST course)

    Time frame: From first to last session of LAP-ST course (average approximately 2 weeks)

    Measured by: the elicitation of therapeutic seizure in the brain and assessed by using EEG

Secondary outcomes

  1. Memory (cognitive side effects)

    Time frame: From Baseline to end of acute course (average 2 weeks)

    Measured by: Mini Mental State Examination

  2. Time to reorientation

    Time frame: From Baseline to end of acute course (average 2 weeks)

    Measured by: Time to Orientation Test

  3. Efficacy

    Time frame: From Baseline to end of acute course (average 2 weeks)

    Montgomery-Åsberg Depression Rating Scale (MADRS) for depressive episodes of mood disorders

  4. Efficacy

    Time frame: From Baseline to end of acute course (average 2 weeks)

    Brief Psychiatric Rating Scale (BPRS) for psychotic disorders

Sponsors and collaborators

Lead sponsor

Behman Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2016
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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