Sun 2012.
Study characteristics | ||
Methods | Randomised, single‐blind, non‐placebo‐controlled, parallel‐design study Baseline evaluation period: 4 weeks Follow‐up period: 8 weeks 2 treatment arms: high‐intensity rTMS at 90% of RMT (n = 31) and low‐intensity rTMS at 20% RMT (n = 29) |
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Participants | 60 participants randomised. Mean age 20.5 years (SD 7 years). 41 male participants, 19 female participants Various types of epilepsies, but the majority were focal epilepsy with or without secondary generalisation. 20 participants had previously undergone surgical resection which failed to control the seizures. |
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Interventions | Treatment period: 2 weeks rTMS was delivered 3 times a day for 2 weeks to the focal epileptic zone best reflected on EEG with 500 stimuli at 0.5 Hz, separated by a 600‐second interval |
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Outcomes | Change in seizure frequency per week post‐treatment Proportion of people experiencing adverse events and withdrawals from the study Effect of rTMS on interictal ED at 60 minutes |
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Notes | The design of this study was different from the others due to no placebo control arm: there were four active treatment arms. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence numbers generated by computer‐assisted randomisation program |
Allocation concealment (selection bias) | Unclear risk | Concealment of allocation not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and study personnel blinded except for those delivering therapy |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor was blinded to intervention group of participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of missing data, and study attrition reported. ITT analysis used. |
Selective reporting (reporting bias) | Low risk | Study protocols were not available. Primary and secondary outcomes stated in the methods section were reported in the results, all expected outcomes were reported. |
Other bias | Low risk | No other sources of bias identified |