Reducing adverse electroconvulsive treatment effects on memory by magnetic stimu

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" Reducing adverse electroconvulsive treatment effects on memory by

magnetic stimulation "

http://www.controlled-trials.com/ISRCTN05721091

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Reducing adverse electroconvulsive treatment effects on memory by

magnetic

stimulation ISRCTN ISRCTN05721091 Title of trial/grant title

Reducing adverse electroconvulsive treatment effects on memory by

magnetic

stimulation Acronym N/A Serial number at source G0401083 Study

hypothesis 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? Research ethics

review

Ethics approval not yet received as of 07/06/06 Study design

Randomised

controlled trial Countries of trial United Kingdom Disease or

condition Memory impairment Participants - inclusion criteria 1.

Referred to and accepted by ECT service for treatment of major

depressive

episode2. Able to give informed consent to ECT and to trial

procedure3. If

patient is detained, ECT would be given with patient's consent (valid

T2 form

completed) Participants - exclusion criteria 1. Contraindications for

ECT

or anaesthesia2. Unable or unwilling to give informed consent to ECT

or to trial

procedure3. Patients with organic diagnoses (e.g. dementia,

schizophrenia and

substance abuse)

4. Patients with metallic implants or pacemakers

5. Pregnancy

6. Aged <18 years Anticipated start date 01/04/2006 Anticipated end

date 31/03/2008 Target number of participants 2 x 40 Interventions

1. Randomisation to either ECT or MST groups2. 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. Primary outcome(s) Last follow-up six months after

course of

treatment of last recruited subject recruited before 31st March 2008

or 80th

subject recruited Secondary outcome(s) Sources of funding Medical

Research Council (MRC), reference number: G0401083 Contact name Prof

Klaus Ebmeier Address Kennedy Tower

Morningside Park City/town Edinburgh Zip/Postcode EH10 5HF

Country United Kingdom Tel +44 (0)131 5376505 Email

k.ebmeier@... Sponsor University of Edinburgh (UK) Address

The University of Edinburgh

Old College

South Bridge City/town Edinburgh Zip/Postcode EH8 9YL

Country United Kingdom Sponsor website:

http://www.ed.ac.uk/contact.html Date applied 19/04/2006 Last edited

07/06/2006 Date ISRCTN assigned 07/06/2006

ISRCTN News 23 Oct 2006: ISRCTN records can now be accessed directly

from relevant PubMed abstracts 6 Sep 2006: Country of trial has been

added

to the data items required for trial registration with the ISRCTN 19

May

2006: WHO announces 20 data items required for trial registration 01

March

2006: ISRCTN is pleased to announce the current membership of its

Governing

Board 10 Jan 2006: ISRCTN Register is open to other study designs

apart

from randomised controlled trials More CCT news

© ISRCTN

[Guest guest]

This is poppycock. In the USA houses are required to be built so far away from

power lines because of cancer causing effects from the electromagnetic fields

generated. That's way, way less electromagnetic waves than this " magnetic

stimulation " .

Why can't these idiots study something like nutrients, better sleep,

reduction of toxins or exercise. Complete morons, very smart but

moronic none the less. How enigmatic that these fairly

brilliant guys can be so tunnel-vision stupid is beyond me.

Note to self: intelligence and common sense don't necessarily run together.

Jim

" Reducing adverse electroconvulsive treatment effects on memory by

magnetic stimulation "

http://www.controlled-trials.com/ISRCTN05721091

Unique identification scheme International

databases home | my details | ISRCTN Register | mRCT | UKCTR

| links | information | press Find

trials ISRCTN Register

tips on searching

Registration apply

for ISRCTN

Information

introduction governing board

ISRCTN FAQs data set

letter of agreement request information

guidance notes

[ ...Back to search results ] [ Print-friendly version ]

Reducing adverse electroconvulsive treatment effects on memory by

magnetic

stimulation ISRCTN ISRCTN05721091 Title of trial/grant title

Reducing adverse electroconvulsive treatment effects on memory by

magnetic

stimulation Acronym N/A Serial number at source G0401083 Study

hypothesis 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? Research ethics

review

Ethics approval not yet received as of 07/06/06 Study design

Randomised

controlled trial Countries of trial United Kingdom Disease or

condition Memory impairment Participants - inclusion criteria 1.

Referred to and accepted by ECT service for treatment of major

depressive

episode2. Able to give informed consent to ECT and to trial

procedure3. If

patient is detained, ECT would be given with patient's consent (valid

T2 form

completed) Participants - exclusion criteria 1. Contraindications for

ECT

or anaesthesia2. Unable or unwilling to give informed consent to ECT

or to trial

procedure3. Patients with organic diagnoses (e.g. dementia,

schizophrenia and

substance abuse)

4. Patients with metallic implants or pacemakers

5. Pregnancy

6. Aged <18 years Anticipated start date 01/04/2006 Anticipated end

date 31/03/2008 Target number of participants 2 x 40 Interventions

1. Randomisation to either ECT or MST groups2. 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 SpectrumT

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. Primary outcome(s) Last follow-up six months after

course of

treatment of last recruited subject recruited before 31st March 2008

or 80th

subject recruited Secondary outcome(s) Sources of funding Medical

Research Council (MRC), reference number: G0401083 Contact name Prof

Klaus Ebmeier Address Kennedy Tower

Morningside Park City/town Edinburgh Zip/Postcode EH10 5HF

Country United Kingdom Tel +44 (0)131 5376505 Email

k.ebmeier@... Sponsor University of Edinburgh (UK) Address

The University of Edinburgh

Old College

South Bridge City/town Edinburgh Zip/Postcode EH8 9YL

Country United Kingdom Sponsor website:

http://www.ed.ac.uk/contact.html Date applied 19/04/2006 Last edited

07/06/2006 Date ISRCTN assigned 07/06/2006

ISRCTN News 23 Oct 2006: ISRCTN records can now be accessed directly

from relevant PubMed abstracts 6 Sep 2006: Country of trial has been

added

to the data items required for trial registration with the ISRCTN 19

May

2006: WHO announces 20 data items required for trial registration 01

March

2006: ISRCTN is pleased to announce the current membership of its

Governing

Board 10 Jan 2006: ISRCTN Register is open to other study designs

apart

from randomised controlled trials More CCT news

© ISRCTN

[Guest guest]

very clever deception that only appears to us unenlightened poor souls to be

stupidity, think Hinkley California, Love Canal, does the Cuyahoga River still

catch fire, ya know come to think of it, will anybody be held responsible for

cleaning up the mess that has been left of so many lives

Re: Reducing adverse electroconvulsive treatment

effects on memory by magnetic stimu

This is poppycock. In the USA houses are required to be built so far away from

power lines because of cancer causing effects from the electromagnetic fields

generated. That's way, way less electromagnetic waves than this " magnetic

stimulation " .

Why can't these idiots study something like nutrients, better sleep,

reduction of toxins or exercise. Complete morons, very smart but

moronic none the less. How enigmatic that these fairly

brilliant guys can be so tunnel-vision stupid is beyond me.

Note to self: intelligence and common sense don't necessarily run together.

Jim

" Reducing adverse electroconvulsive treatment effects on memory by

magnetic stimulation "

http://www.controlled-trials.com/ISRCTN05721091

Unique identification scheme International

databases home | my details | ISRCTN Register | mRCT | UKCTR

| links | information | press Find

trials ISRCTN Register

tips on searching

Registration apply

for ISRCTN

Information

introduction governing board

ISRCTN FAQs data set

letter of agreement request information

guidance notes

[ ...Back to search results ] [ Print-friendly version ]

Reducing adverse electroconvulsive treatment effects on memory by

magnetic

stimulation ISRCTN ISRCTN05721091 Title of trial/grant title

Reducing adverse electroconvulsive treatment effects on memory by

magnetic

stimulation Acronym N/A Serial number at source G0401083 Study

hypothesis 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? Research ethics

review

Ethics approval not yet received as of 07/06/06 Study design

Randomised

controlled trial Countries of trial United Kingdom Disease or

condition Memory impairment Participants - inclusion criteria 1.

Referred to and accepted by ECT service for treatment of major

depressive

episode2. Able to give informed consent to ECT and to trial

procedure3. If

patient is detained, ECT would be given with patient's consent (valid

T2 form

completed) Participants - exclusion criteria 1. Contraindications for

ECT

or anaesthesia2. Unable or unwilling to give informed consent to ECT

or to trial

procedure3. Patients with organic diagnoses (e.g. dementia,

schizophrenia and

substance abuse)

4. Patients with metallic implants or pacemakers

5. Pregnancy

6. Aged <18 years Anticipated start date 01/04/2006 Anticipated end

date 31/03/2008 Target number of participants 2 x 40 Interventions

1. Randomisation to either ECT or MST groups2. 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 SpectrumT

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. Primary outcome(s) Last follow-up six months after

course of

treatment of last recruited subject recruited before 31st March 2008

or 80th

subject recruited Secondary outcome(s) Sources of funding Medical

Research Council (MRC), reference number: G0401083 Contact name Prof

Klaus Ebmeier Address Kennedy Tower

Morningside Park City/town Edinburgh Zip/Postcode EH10 5HF

Country United Kingdom Tel +44 (0)131 5376505 Email

k.ebmeier@... Sponsor University of Edinburgh (UK) Address

The University of Edinburgh

Old College

South Bridge City/town Edinburgh Zip/Postcode EH8 9YL

Country United Kingdom Sponsor website:

http://www.ed.ac.uk/contact.html Date applied 19/04/2006 Last edited

07/06/2006 Date ISRCTN assigned 07/06/2006

ISRCTN News 23 Oct 2006: ISRCTN records can now be accessed directly

from relevant PubMed abstracts 6 Sep 2006: Country of trial has been

added

to the data items required for trial registration with the ISRCTN 19

May

2006: WHO announces 20 data items required for trial registration 01

March

2006: ISRCTN is pleased to announce the current membership of its

Governing

Board 10 Jan 2006: ISRCTN Register is open to other study designs

apart

from randomised controlled trials More CCT news

© ISRCTN