Low Pulse Amplitude Focal ECT (LAP Study)

Augusta University

Status and phase

Completed

Phase 3

Conditions

Depression

Treatments

Device: spectrum 5000Q ECT device (RUL LAP ECT)

Device: spectrum 5000Q ECT device (RUL ECT)

Study type

Interventional

Funder types

Other

Identifiers

NCT02583490

Low Pulse Amplitude Focal ECT

Details and patient eligibility

About

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.

Full description

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.

Enrollment

11 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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