JOURNAL TRANSCRIPT
NICE interventional procedure consultation document, June 2015
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Interventional procedure consultation document
Repetitive transcranial magnetic stimulation for depression Depression causes low mood or sadness that can last for weeks or months. People with depression often feel hopeless and lose interest in things they used to enjoy. Other symptoms include sleeping badly, and having no appetite or sex drive. Transcranial magnetic stimulation is a possible treatment for depression that uses a powerful electromagnet, placed on the scalp, to produce electric currents in the brain.
The National Institute for Health and Care Excellence (NICE) is examining repetitive transcranial magnetic stimulation for depression and will publish guidance on its safety and efficacy to the NHS. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about repetitive transcranial magnetic stimulation for depression. This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
comments on the provisional recommendations
the identification of factual inaccuracies
additional relevant evidence, with bibliographic references where possible.
Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation. The process that NICE will follow after the consultation period ends is as follows.
The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
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NICE interventional procedure consultation document, June 2015
The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS.
For further details, see the Interventional Procedures Programme process guide, which is available from the NICE website. Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so. In order to help us promote equality through our guidance, we should be grateful if you would consider the following question: Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others? Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate. Closing date for comments: 23 July 2015 Target date for publication of guidance: November 2015
1
Provisional recommendations
1.1
The evidence on repetitive transcranial magnetic stimulation for depression shows no major safety concerns. The evidence on its efficacy in the short term is adequate, although the clinical response is variable and some patients may not benefit. Repetitive transcranial magnetic stimulation for depression may be used with normal arrangements for clinical governance and audit, provided that patients are informed, during the consent process, about the other treatment options available and they understand the
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NICE interventional procedure consultation document, June 2015
possibility that they may derive little or no benefit from the procedure. 1.2
NICE encourages publication of further evidence on patient selection, the use of maintenance treatment and long-term outcomes.
2
Indications and current treatments
2.1
Depression is a common disorder. It is characterised by persistent sadness, loss of interest or pleasure, feelings of guilt or low selfworth, disturbed sleep, appetite and libido, tiredness and poor concentration. It is also often accompanied by feelings of hopelessness and suicidal thoughts. Depression can last from weeks to years, and can be recurrent. It can substantially impair an individual’s ability to function at work or cope with daily life. Treatments for depression include a range of psychological therapies and antidepressant medications. In severe depression, electroconvulsive therapy or transcranial direct current stimulation are sometimes used.
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The procedure
3.1
Repetitive transcranial magnetic stimulation (rTMS) does not need anaesthesia and can be done on an outpatient basis. A purposemade electromagnetic coil is held against the scalp with the intention of inducing electric currents in the cerebral cortex. Imaging may be used to help target specific areas of the brain. Treatment is usually considered for patients with depression that has not responded to antidepressant medication.
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NICE interventional procedure consultation document, June 2015
3.2
In rTMS, repetitive pulses of electromagnetic energy are delivered at various frequencies or stimulus intensities. Conventional rTMS uses continuous pulses of electromagnetic energy whereas thetaburst rTMS uses intermittent pulses. Stimulation can either be delivered unilaterally, over the left or right dorso-lateral prefrontal cortex, or bilaterally over both cortices. Bilateral stimulation may be done sequentially or simultaneously. Treatment with rTMS usually comprises daily sessions lasting about 30 minutes, typically for 2 to 6 weeks.
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Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview. 4.1
In a systematic review of 40 randomised controlled trials including 1592 patients with depression (type unspecified) treated by repetitive transcranial magnetic stimulation (rTMS, n=751) or sham stimulation (n=632), meta-analysis of mean changes in unspecified depression rating scales showed a significant effect in favour of rTMS (Hedges’ g value of 0.55, p