The Antidepressive Effect of rTMS as add-on to ECT (TMS)

February 4, 2021 updated by: Poul Erik Buchholtz, University of Aarhus

The Antidepressant Efficacy of Repetitive Transcranial Magnetic Stimulation ( rTMS) as add-on to Electroconvulsive Therapy (ECT). A Double Blind Randomized Controlled Trial.

The aim of the present study is to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission .

To investigate the correlation between blood concentration of specific inflammation makers and change in depressive symptoms during treatment

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

ECT is a well-established and effective method for the treatment of severe depression. During the last decades, rTMS has appeared as a potential new non-invasive antidepressant method, which may be a potential alternative to ECT due to fewer side effects.

Both methods expose the brain to an electric current. But while ECT is associated with global cerebral stimulation elicited by an epileptic seizure, rTMS implies non-convulsive focal stimulation through a time varying magnetic field. Thus, the antidepressant effect of rTMS does not depend on seizure activity and consequently requires no anesthesia. In addition, rTMS seems not to be associated with cognitive disturbances.

Previous research indicates that the antidepressant effect of rTMS is associated with specific stimulation of the dorsolateral prefrontal cortex. The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex (1-4). Few have used right prefrontal low frequency rTMS, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation (5-10). Both models have been used with varying results. Meta-analysis of the antidepressant effect of rTMS (11,x) have found a modest, statistically significant antidepressant effect but generally definite conclusions on the antidepressant effect of rTMS has been difficult to draw, probably because of small and selected study populations, varying ways of stimulation and other confounding factors in the clinical setting.

The important clinical question of whether rTMS may substitute ECT in the treatment of depression has almost exclusively been elucidated in studies using high frequency stimulation of the left frontal cortex. Some of these suggest that the effectiveness of rTMS is equal to that of ECT in non-delusional patients (12-19). However, a recent investigation has compared the antidepressant efficacy and side effects of right prefrontal low frequency rTMS with ECT. In this study the mean Hamilton total 17-item (HAM-D score) scores were reduced significantly over time in both groups (ECT: p<0.001, rTMS: p<0.001); but ECT was more effective than rTMS on a short term after 3 weeks of treatment. The outcome did not point to right frontal low frequency rTMS as a first line substitute for ECT, but it might have place in the treatment of depression as add on to other types of treatment.

ECT is normally administered 3 times a week for 3-4 weeks. Daily treatment sessions might accelerate remission, but is impossible because of cognitive side effects. However, rTMS seems not to be associated with reduction in cognitive performance and might potentiate the antidepressant efficacy of ECT. Therefore the investigators have found it clinical interesting to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission .

In addition we want to investigate te correlation between change in depressive symptoms and

-blood concentration of specific inflammation CNS- makers

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

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

  • Denmark
    • Risskov
      • Aarhus, Risskov, Denmark, 8240
        • Aarhus University Hospital, Risskov

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients admitted to the Psychiatric Hospital of Aarhus

  • Patients referred for ECT
  • Age 18-80 years
  • Moderate or severely depressed patients (ICD-10(DSM-IV)
  • HAM-D score (17-item) ≥20 and/or Ham-D subscale ≥10.

Exclusion Criteria:

  • Organic brain disease
  • Epilepsy or disposition to epilepsy
  • Metallic objects in chest or brain
  • Cardiac pacemaker
  • Somatic diseases associated with brain dysfunction
  • Pregnancy
  • Severe agitation or delirium
  • Alcohol or drug dependence (ICD-10)
  • Use of coercive measures
  • The patient does not wish to participate

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low frequency rTMS
Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week
Device: Low frequency (1 hz) rTMS, as add-on to ECT
Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.
Sham Comparator: Sham-rTMS
Sham right prefrontal rTMS 2 times a week
Device: Sham-rTMS
Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission
Time Frame: 7 weeks
The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcomeRemission is defined by a Hamilton 17-item total score < 8.
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response
Time Frame: 7 weeks
The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcome. Response is defined by a reduction in the Hamilton 17 item score of >= 50%
7 weeks

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Poul Erik Buchholtz, MD, Poul Erik Buchholtz, MD Telephone: 004578472109 Email: poulhans@rm.dk

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)

April 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 25, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-509-12

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.

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