Mood DisordersPhase 1NCT02928159
Low Pulse Amplitude Seizure Therapy (LAP-ST Study)
A Phase 1 study testing Mecta spectrum 5000Q device in people with Mood Disorders and Schizophrenia Spectrum and Other Psychotic Disorders, run by Behman Hospital.
Trial summary
This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Mood Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Mecta spectrum 5000Q device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).
Read the 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.
- Being tested
- Mecta spectrum 5000Q device
- 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
- Medical subject headings
- Mood Disorders, Schizophrenia Spectrum and Other Psychotic Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mecta spectrum 5000Q deviceDevice
LAP-ST and Right Unilateral (RUL) electrode placement.
| Study group | Role | What they receive |
|---|---|---|
| Low Pulse Amplitude Seizure Therapy | Experimental | Course of Right Unilateral Ultrabrief LAP-ST using Mecta spectrum 5000Q Device. Receives: Device: Mecta spectrum 5000Q device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (by successfully inducing therapeutic seizures during LAP-ST course)
Measured by: the elicitation of therapeutic seizure in the brain and assessed by using EEG
Measured: From first to last session of LAP-ST course (average approximately 2 weeks)
Secondary outcomes (4)
Memory (cognitive side effects)
Measured by: Mini Mental State Examination
Measured: From Baseline to end of acute course (average 2 weeks)
Time to reorientation
Measured by: Time to Orientation Test
Measured: From Baseline to end of acute course (average 2 weeks)
Efficacy
Montgomery-Åsberg Depression Rating Scale (MADRS) for depressive episodes of mood disorders
Measured: From Baseline to end of acute course (average 2 weeks)
Efficacy
Brief Psychiatric Rating Scale (BPRS) for psychotic disorders
Measured: From Baseline to end of acute course (average 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Behman Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Sidhom, Behman Hospital
- Investigators
- Nagy A. Youssef, Principal investigator, Medical College of Georgia, Augusta UniversityEmad Sidhom, Principal investigator, Behman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928159
- Sponsor's protocol ID
- 001
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28667887
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Pulse Amplitude Seizure Therapy (LAP-ST Study)
- ClinicalTrials.gov ID
- NCT02928159
- Acronym / sponsor ID
- 001
- Keywords
- Low Pulse Amplitude Seizure Therapy, Electroconvulsive Therapy, Low Pulse Amplitude Electroconvulsive Therapy, Low Pulse Amplitude ECT, LAP, LAP-ST, ECT, Mood disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Behman HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Pulse Amplitude Seizure Therapy | Experimental | Device: Mecta spectrum 5000Q deviceCourse of Right Unilateral Ultrabrief LAP-ST using Mecta spectrum 5000Q Device. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mecta spectrum 5000Q deviceLAP-ST and Right Unilateral (RUL) electrode placement. | Device | Low Pulse Amplitude Seizure Therapy |
Primary outcome
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
4 secondary outcomes
Memory (cognitive side effects)
Time frame: From Baseline to end of acute course (average 2 weeks)
Time to reorientation
Time frame: From Baseline to end of acute course (average 2 weeks)
Efficacy
Time frame: From Baseline to end of acute course (average 2 weeks)
Efficacy
Time frame: From Baseline to end of acute course (average 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Derived from this study: PubMed 28667887Youssef 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagy A. Youssef principal investigator
Medical College of Georgia, Augusta University
Emad Sidhom principal investigator
Behman Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mecta spectrum 5000Q device in people with Mood Disorders and Schizophrenia Spectrum and Other Psychotic Disorders, run by Behman Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.