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NCT Number: NCT02583490

Low Pulse Amplitude Focal ECT (LAP Study)

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Colleage of Georgia, Augusta University

Evans, Georgia, 30809, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

spectrum 5000Q ECT device (RUL ECT)

Device

spectrum 5000Q ECT device (RUL LAP ECT)

Device

Primary outcomes

  1. Memory (cognitive side effects)

    Time frame: From Baseline to end of acute course (typically after 4 weeks)

    Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome)

  2. Time to reorientation

    Time frame: From Baseline to end of acute course (typically after 4 weeks)

    Measured by Time to Orientation Test (TRO, primary outcome)

Secondary outcomes

  1. Resilience

    Time frame: From Baseline to end of acute course (typically after 4 weeks)

    Connor-Davidson Resilience Scale

  2. Suicidal Ideation

    Time frame: From Baseline to end of acute course (typically after 4 weeks)

  3. Depression

    Time frame: From Baseline to end of acute course (typically after 4 weeks)

    used to determine remission status; measured by Montgomery-Åsberg Depression Rating Scale (MADRS)

  4. Depression

    Time frame: From Baseline to end of acute course (typically after 4 weeks)

    Patient Health Questionnaire (PHQ 9)

  5. Trauma symptoms

    Time frame: From Baseline to end of acute course (typically after 4 weeks)

    PTSD Checklist

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

Low Pulse Amplitude Focal Electroconvulsive Therapy

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 22, 2015
Registry last updated
Jun 20, 2019

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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