Repetitive transcranial magnetic stimulation for depression

5 Safety

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 interventional procedure overview.

5.1 A self‑limiting complex partial seizure was reported in 1 patient who had unilateral repetitive transcranial magnetic stimulation (rTMS), at a frequency of 20 Hz and at 110% of the motor threshold. The patient was awake after 8 seconds; she was alert with no postictal confusion and had no memory of what happened. No subsequent physical sequelae were reported.

5.2 A hypomanic episode was reported in 1 patient, soon after completion of therapy, in a randomised controlled trial of 130 patients treated by 1 Hz or 2 Hz rTMS. The exact timing of occurrence was not reported.

5.3 Headache was reported in 10% (46/472) of patients treated by high‑frequency rTMS, 4% (4/109) treated by low‑frequency rTMS and 3% (12/461) given sham stimulation in a systematic review of 40 randomised controlled trials that included 1592 patients with depression (type unspecified).

5.4 Scalp discomfort was reported in 9% (45/472) of patients treated by high‑frequency rTMS, 2% (2/109) treated by low‑frequency rTMS and 2% (9/461) given sham stimulation in the systematic review of 40 randomised controlled trials that included 1592 patients with depression (type unspecified).

5.5 Pain at the rTMS application site was reported in 6% (6/99) of patients in a case series of 120 patients with major depressive disorder treated by rTMS.

5.6 Facial twitching was reported in 2% (9/472) of patients treated by high‑frequency rTMS, none treated by low‑frequency rTMS (n=109) and none given sham stimulation (n=461) in the systematic review of 40 randomised controlled trials that included 1592 patients with depression (type unspecified).

5.7 Local erythema was reported in 1% (6/472) of patients treated by high‑frequency rTMS, none treated by low‑frequency rTMS (n=109) and none given sham stimulation (n=461) in the systematic review of 40 randomised controlled trials that included 1592 patients with depression (type unspecified).

5.8 Drowsiness was reported in 3% (12/472) of patients treated by high‑frequency rTMS, none treated by low‑frequency rTMS (n=109) and none given sham stimulation (n=461) in the systematic review of 40 randomised controlled trials that included 1592 patients with depression (type unspecified).

5.9 Vertigo was reported in no patients in the conventional rTMS (n=98) group and 1 patient in the theta‑burst TMS group (n=87) in a non‑randomised comparative study of 185 patients with treatment resistant depression.

5.10 Increasingly hostile thoughts were reported in no patients in the conventional rTMS group (n=98) and 1 patient in the theta‑burst rTMS group (n=85) in the non‑randomised comparative study of 185 patients with treatment‑resistant depression. The timing of occurrence was not reported.

5.11 Device‑related insomnia was reported in 1 patient in the case series of 120 patients with major depressive disorder treated by rTMS.

5.12 Device‑related arthralgia was reported in 1 patient in the case series of 120 patients with major depressive disorder treated by rTMS.

5.13 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: discomfort, unpleasant twitching, worsening psychomotor agitation in patients with mixed affective disorder, transient confusion, transient problems with concentration and/or working memory, and transient hearing loss. They did not suggest any theoretical adverse events.