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 3 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial (with 1 secondary analysis) and 1 open-label trial. It is presented in the summary of key evidence section in the overview.
The professional experts and the committee considered the key efficacy outcomes to be: improved quality of life, reduced symptoms and reduced need for medication.
The professional experts and the committee considered the key safety outcomes to be: pain, skin irritation, negative effect on cognitive function and worsening of symptoms.
Patient commentary was sought but none was received.
The committee was informed that the procedure is primarily indicated for people for whom medication is unsuitable.
The device has regulatory approval for use in people aged 7 and over, but all the evidence that the committee considered was from children.
The committee was informed that treatment usually takes place at night and that a course of treatment may need to be repeated.