5 Safety

Guidance

This section describes safety 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 overview.

5.1

No device-related serious adverse events were reported in the randomised controlled trial of 164 patients.

5.2

Slight 'unsustained' dizziness (n=1), drowsiness (n=1) and tiredness (n=2) were reported in a case series of 42 patients after treatment with low- or high-intensity transcranial magnetic stimulation (TMS). None of these events recurred or needed medical attention.

5.3

Amyostasia (muscle tremor causing difficulty in standing, n=1), irritability (n=1), 'vigorous dreams' (n=1) and phonophobia (n=1) were reported after repeated TMS (rTMS) treatment in the case series of 27 patients.

5.4

The specialist advisers listed transient muscle contraction, pain at the stimulation site and hearing impairment during rTMS as additional anecdotal adverse events. The specialist advisers considered theoretical adverse events to include local scalp irritation, mood disorders, cognitive impairment, triggering of epilepsy during treatment and 'kindling' leading to seizures. One adviser raised the theoretical possibility of 'permanent neural changes' with prolonged use of rTMS.