Reducing adverse electroconvulsive treatment effects on memory by magnetic stimulation
| ISRCTN | ISRCTN05721091 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05721091 |
| Protocol serial number | G0401083 |
| Sponsor | University of Edinburgh (UK) |
| Funder | The Medical Research Council (MRC) (UK) |
- 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
Scientific
Kennedy Tower
Morningside Park
Edinburgh
EH10 5HF
United Kingdom
| Phone | +44 (0)131 5376505 |
|---|---|
| k.ebmeier@ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | We 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) studied | Memory impairment |
| Intervention | 1. 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 Spectrum™ 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 type | Other |
| Primary outcome measure(s) |
Last follow-up six months after course of treatment of last recruited subject recruited before 31st March 2008 or 80th subject recruited |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2008 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/04/2006 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Kennedy Tower
Edinburgh
EH10 5HF
United Kingdom
EH10 5HF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
