Clinical trial NCT02928159: Low Pulse Amplitude Seizure Therapy (LAP-ST Study)
Official title: Low Pulse Amplitude Seizure Therapy (LAP-ST Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Keywords: Low Pulse Amplitude Seizure Therapy
Electroconvulsive Therapy
Low Pulse Amplitude Electroconvulsive Therapy
Low Pulse Amplitude ECT
LAP
LAP-ST
ECT
Mood disorders
Psychotic disorders
Lead sponsor: Behman Hospital
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility (by successfully inducing therapeutic seizures during LAP-ST course)
timeFrame: From first to last session of LAP-ST course (average approximately 2 weeks)
Secondary outcomes:
measure: Memory (cognitive side effects)
timeFrame: From Baseline to end of acute course (average 2 weeks)
measure: Time to reorientation
timeFrame: From Baseline to end of acute course (average 2 weeks)
measure: Efficacy
timeFrame: From Baseline to end of acute course (average 2 weeks)
measure: Efficacy
timeFrame: From Baseline to end of acute course (average 2 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Medical College of Georgia, Augusta University
name: Nagy A. Youssef
role: PRINCIPAL_INVESTIGATOR
affiliation: Behman Hospital
name: Emad Sidhom
role: PRINCIPAL_INVESTIGATOR
References:
citation: Youssef NA, Sidhom E. Feasibility, safety, and preliminary efficacy of Low Amplitude Seizure Therapy (LAP-ST): A proof of concept clinical trial in man. J Affect Disord. 2017 Nov;222:1-6. doi: 10.1016/j.jad.2017.06.022. Epub 2017 Jun 16.