Zanette 2008.
Methods | Prospective RCT 2 weeks treatment and 2 weeks follow‐up |
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Participants | 10 patients with probable or definite ALS were enrolled. 5 participants in active stimulation group and 5 participants in sham stimulation group Age: 43 to 72 years Men: 7 Women: 3 Disease duration: 7 to 18 months |
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Interventions | Experimental group: for upper‐limb cortical areas on both sides, a Super Rapid magnetic stimulator (The Magstim Co., UK) connected to a figure‐of‐eight focal coil was performed (5Hz, 20 trains of 15 stimuli, 60 s interval between trains; 110% resting motor threshold). rTMS was delivered for 5 consecutive days per week for 2 weeks Control group: performed using the same stimulator connected to a specific sham coil that have no stimulating effect on the cortex but produces similar auditory and scalp sensations as the active coil treatment with manipulation, which delivered 5 consecutive days per week for 2 weeks All participants were taking riluzole |
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Outcomes | Changes in ALSFRS‐R scores, muscle strength and fatigue 2 weeks after the end of rTMS | |
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 | "a randomised trial on a group of ALS patients", the detailed method was not stated |
Allocation concealment (selection bias) | Unclear risk | "a randomised trial on a group of ALS patients", the detailed method was not stated |
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 | Unclear risk | The study report does not state whether investigators were blinded to treatment assignment until completion of the final analyses. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Four weeks assessments were available for all randomised participants |
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 |
ALS: amyotrophic lateral sclerosis; ALSFRS‐R: Amyotrophic Lateral Sclerosis Functional Rating Scale‐Revised; BDNF: brain derived neurotrophic factor; RCT: randomised controlled trial; rTMS: repetitive transcranial magnetic stimulation.