Guidance
3 Committee considerations
The evidence
3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 11 sources, which was discussed by the committee. The evidence included 1 systematic review, 1 randomised controlled trial (2 publications providing 1- and 2‑year follow-up data), 2 non-randomised comparative studies and 6 case series, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: sustained reduction in tremor, improved quality of life and functional improvement.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: unintentional neurological consequences and intracerebral bleeding.
3.4 No patient commentary was sought because this procedure is currently only done in research in the UK.
Committee comments
3.5 The committee noted that essential tremor can have major consequences on the quality of life for many people.
3.6 This procedure is an alternative to more invasive methods used to lesion the thalamus. The lesion produced is permanent.
3.7 While this procedure does not preclude subsequent treatments for essential tremor (such as deep brain stimulation), the effects on those subsequent treatments are unknown.
3.8 There is a comprehensive training programme offered by the company manufacturing the device used in this procedure.
ISBN: 978-1-4731-2834-7