Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults (MSTvsEST)

August 18, 2020 updated by: Stefan Rowny, New York State Psychiatric Institute

Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy

To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in elderly patients with a major depressive episode, who are randomly assigned to receive an acute course of MST or ECT.

The investigators hypothesize:

  1. MST and ECT will have similar antidepressant efficacy
  2. MST will have less post-treatment amnesia than ECT as reflected in a primary measures of anterograde and retrograde amnesia following the acute treatment phase.
  3. At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in older adults currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. ECT is known to be highly effective in treating depression, but it can have some adverse cognitive side effects. MST is a new form of convulsive therapy that is being developed as a means of improving the side effect profile of ECT so that more patients may benefit without suffering significant detrimental effects on cognition.

Both ECT and MST rely on a therapeutic seizure, but they do so in different ways. In ECT, an electrical stimulator is used to pass electrical current between two electrodes placed on the surface of person's head, which causes some electricity to go through the brain and cause a seizure. In MST, a magnetic stimulator is used to create a magnetic field in a targeted area of the brain, which induces a small electrical field in the neurons that causes a seizure. Treatments will be administered three times a week.

In addition to the treatment sessions, this study will involve a number of assessments at different time-points (i.e., baseline prior to treatment, post-treatment, 2 months post-treatment and 6 months post-treatment) that are used to evaluate the person's antidepressant response and the physical and cognitive side effects of treatment.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 55-90
  • Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
  • Willing and capable to provide informed consent
  • Convulsive therapy clinically indicated
  • Hamilton Rating Scale for Depression (HRSD24)≥ 20
  • Mini Mental State Exam (MMSE) ≥ 24
  • For outpatients: responsible adult living with the patient

Exclusion Criteria:

  • Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure)
  • History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion
  • Presence of devices that may be affected by MST (pacemaker, medication pump, cochlear implant, implanted brain stimulator, or vagus nerve stimulator implanted)
  • History of head trauma with loss of consciousness for greater than 5 minutes
  • History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
  • History of substance abuse or dependence in past 3 months
  • Failure to respond to an adequate course of ECT in the current depressive episode
  • History of ECT in the past 6 months and/or failure to respond to an adequate trial of ECT lifetime
  • Presence of intracardiac lines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic Seizure Therapy (MST)
MagVenture MagPro MST device
Device: MagVenture MagPro MST
Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.
Active Comparator: RUL ECT
Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus
Biological: RUL ECT
RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Other Names:
  • Right Unilateral Electroconvulsive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression, 24-Item (HRSD-24)
Time Frame: baseline (pre-treatment) and post-treatment

The unabbreviated scale title is "Hamilton Rating Scale for Depression." As its title suggests, this is a clinical measure of major depressive disorder.

The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome:

0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression

Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study.
baseline (pre-treatment) and post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: Stefan B Rowny, MD, MFA, NYSPI/Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6427

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on MagVenture MagPro MST

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe