Low Pulse Amplitude Focal ECT (LAP Study)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This protocol proposes a pilot randomized clinical trial to examine whether Low Pulse Amplitude Focal ECT (LAP) has a more favorable cognitive profile compared to conventional unilateral ECT and that it has similar effects as traditional ECT in reducing suicidality. The study will enroll 10 patients recruited from the Medical College of Georgia (at Georgia Regents University/Augusta University, GRU/AU) as the only site of the study. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Treatment Study of Catatonia Patients

NCT02734498

Catatonia

TERMINATED NA

Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

NCT03297411

Depression

UNKNOWN PHASE2

Enhanced Spatial Targeting in ECT Utilizing FEAST

NCT04099342

Treatment Resistant Depression

SUSPENDED NA

Focused Ultrasound Neuromodulation for Treatment of Temporal Lobe Epilepsy

NCT03657056

Low Intensity Ultrasound Pulsarions

WITHDRAWN NA

Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields

NCT03537469

Electromagnetic Fields Neuronal Plasticity Transcranial Magnetic Stimulation

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Lower amplitude ECT (LAP) has been shown to induce seizures of adequate duration in a single titration session. This current study is hypothesized to increase stimulation focality, thus hypothetically minimizing cognitive side effects.

The central hypothesis is that LAP has significantly less cognitive adverse effects compared to conventional Right Unilateral (RUL) ECT.

The study will enroll 10 patients recruited from Medical College of Georgia. Patients referred to ECT service in the Medical College of Georgia usually occurs from clinical services and private physicians and the study will recruit patients who are clinically indicated to do ECT. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Pulse Amplitude ECT (LAP)

Right Unilateral LAP ECT

Group Type EXPERIMENTAL

spectrum 5000Q ECT device (RUL LAP ECT)

Intervention Type DEVICE

standard Right Unilateral ECT

Group Type ACTIVE_COMPARATOR

spectrum 5000Q ECT device (RUL ECT)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

spectrum 5000Q ECT device (RUL ECT)

Intervention Type DEVICE

spectrum 5000Q ECT device (RUL LAP ECT)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients in whom ECT therapy is clinically indicated
* Males or females patients over 20 years of age
* Current DSM-IV criteria for major depressive episode
* Montgomery-Asberg depression rating scale (MADRS) greater than or equal to 20
* Use of effective method of birth control for women of child-bearing capacity
* Patient is medically stable
* No anticipated need to alter psychotropic medications for the duration of the study
* Ability of patient to fully participate in the informed consent process

Exclusion Criteria

* Unstable or serious medical condition that substantially increases risks of ECT or of cognitive impairment
* Substance use disorders within 1 week of randomization
* History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion that is deemed to affect cognition or safe ECT treatment
* Vagal Nerve Stimulator implanted
* Female patients who are pregnant or plan to be pregnant during the study breast-feeding
* Implanted devices that make ECT unsafe, or a skull defect
* Significant cognitive impairment (Mini-Mental State Examination (MMSE) less than 24)
* ECT in the past 1 months
* Benzodiazepine use will be limited to no more than 3 mg per day of lorazepam or its equivalents. Antidepressants and antipsychotics will be held constant during the ECT course of the study

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No