Reducing adverse electroconvulsive treatment effects on memory by magnetic stimulation

ISRCTN ISRCTN05721091
DOI https://doi.org/10.1186/ISRCTN05721091
Secondary identifying numbers G0401083
Submission date
19/04/2006
Registration date
07/06/2006
Last edited
06/10/2009
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Klaus Ebmeier
Scientific

Kennedy Tower
Morningside Park
Edinburgh
EH10 5HF
United Kingdom

Phone +44 (0)131 5376505
Email k.ebmeier@ed.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesWe propose a two-year pilot randomised controlled trial of electroconvulsive treatment (ECT) versus magnetic seizure therapy (MST) in 80 Edinburgh patients recruited from 100 new treatment courses started per year in Edinburgh (75 after giving informed consent) to examine the following questions:
1. Is MST less liable than ECT to cause anterograde and retrograde memory impairment and what is the likely size of the effect?
2. Is MST equally effective to ECT within the power of a moderately large randomised study with blind evaluation of symptom change?
3. Is MST more user-friendly and user-acceptable than ECT?
4. What is the balance of cost versus benefit comparing ECT and MST in patients referred for ECT?
Ethics approval(s)Ethics approval not yet received as of 07/06/06
Health condition(s) or problem(s) studiedMemory impairment
Intervention1. Randomisation to either ECT or MST groups
2. ECT protocol (treatment as usual): ECT will be administered in line with the latest guidelines from the Royal College of Psychiatrists. Seizure threshold will be measured at the outset of treatment, bilateral ECT given with a dose 50% above threshold, and right unilateral ECT given with a dose initially 300% above threshold. Treatment will be given with a modern constant current ECT machine using doses of 100-400 mC (mode = 150 mC, 800 mA, 20-120 Hz; pulse width 1 ms; MECTA Spectrumâ„¢ 5000 M), and monitored by electroencephalogram (EEG). The clinical team responsible for the patient will determine the need for and duration of treatment, usually between 6 and 12 treatments.
3. MST protocol: MST will be administered mirroring the dose titration process above. Prefrontal coil placement will be used with a stimulation frequency between 50 and 100 Hz at various output strengths. Seizures will be monitored using EEG (split electrodes to prevent heating). The clinical team responsible for the patient will determine the need for and duration of treatment, usually between 6 and 12 treatments. The responsible team can request exit from the protocol and transfer to ECT, if there are clinical concerns, such as deterioration or emerging suicidality.

Added 06/10/09: the trial was stopped due to participant recruitment issues.
Intervention typeOther
Primary outcome measureLast follow-up six months after course of treatment of last recruited subject recruited before 31st March 2008 or 80th subject recruited
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2006
Completion date31/05/2008
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants2 x 40
Key inclusion criteria1. Referred to and accepted by ECT service for treatment of major depressive episode
2. Able to give informed consent to ECT and to trial procedure
3. If patient is detained, ECT would be given with patient's consent (valid T2 form completed)
Key exclusion criteria1. Contraindications for ECT or anaesthesia
2. Unable or unwilling to give informed consent to ECT or to trial procedure
3. Patients with organic diagnoses (e.g. dementia, schizophrenia and substance abuse)
4. Patients with metallic implants or pacemakers
5. Pregnancy
6. Aged <18 years
Date of first enrolment01/04/2006
Date of final enrolment31/05/2008

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Kennedy Tower
Edinburgh
EH10 5HF
United Kingdom

Sponsor information

University of Edinburgh (UK)
University/education

The University of Edinburgh
Old College
South Bridge
Edinburgh
EH8 9YL
Scotland
United Kingdom

Website http://www.ed.ac.uk/contact.html
ROR logo "ROR" https://ror.org/01nrxwf90

Funders

Funder type

Government

The Medical Research Council (MRC) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan