Di Lazarro 2006.
| Methods | Prospective, double‐blind, randomised, placebo‐controlled trial Six months treatment |
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| Participants | Twenty participants (10 men and 10 women; mean age 61.2 ± 10.7 years) with definite ALS were enrolled and allocated to real (n = 10) and sham (n = 10) stimulation group (no more than 24 months of disease duration) | |
| Interventions | Experimental group: rTMS was performed using a butterfly coil held over motor cortex on each hemisphere. Stimulation protocol was the cTBS in which three pulses of stimulation are given at 50 Hz, repeated every 200 ms for a total of 600 pulses. The stimulus intensity was 80% of action motor threshold. rTMS was delivered for 5 consecutive days per month for 6 months Control group: Sham rTMS was performed using the same stimulator connected to the placebo butterfly coil which has no stimulating effect on the cortex but produces similar auditory and tactile sensations as the active coil. The site of stimulation and the number of stimuli was identical to those used for the active magnetic rTMS rTMS was delivered for 5 consecutive days per month for 6 months All participants were taking riluzole |
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| Outcomes | Primary outcomes: rate of decline of ALSFRS‐R score after the end of rTMS treatment (6 months) Secondary outcomes: rate of decline of MMT score after the end of rTMS treatment (6 months) |
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| Notes | It was a single centre trial carried out in Italy | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | 'Patients were randomly allocated by one of the authors (VD) not involved in follow‐up evaluations and data analysis. Stratified block randomisation was performed' ‐ the way the stratified block randomisation was carried out was not mentioned |
| Allocation concealment (selection bias) | Unclear risk | Allocation 'by one of the authors (VD) not involved in follow‐up evaluations and data analysis' ‐ no further details |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical stimulator used for the real rTMS and placebo rTMS, to ensure participants and the neurologists administering the intervention were unaware of the study group |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | The neurologists assessing the outcomes were stated to be blinded to group assignment |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Numbers lost to follow‐up and reasons for this were given, but intention‐to‐treat analysis was not performed |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in the results section of the manuscript |
| Other bias | Low risk | There were no other concerns regarding the risk of bias in this study |