Cazzoli 2012.
Study characteristics | ||
Methods | Hybrid 3‐arm design. Here, combining first 2 arms “cTBS then sham” and “sham then cTBS” to create 2‐arm parallel design without cross‐over Setting: Switzerland, neurorehabilitation clinic | |
Participants | 24 first‐stroke patients with left‐sided neglect and normal or corrected‐to‐normal vision cTBS‐sham = 16, control = 8 Diagnosis of neglect: deficits in at least 2 out of 3 classes of paper‐pencil tests Sex (all patients): 17 men, 7 women Mean age (all patients), years = 58 Stroke type: 14 ischaemic, 10 haemorrhagic Mean (SE) between stroke and treatment = 27 (4.4) days Exclusion criteria: history of epilepsy, prior head trauma, drug and alcohol abuse, major psychiatric disorder | |
Interventions | Continuous TBS was applied by means of a MagPro X100 stimulator 60 mm outer radius (Magnetic Coil Transducer MC‐125). Continuous TBS was delivered with the same protocol described previously (Nyffeler et al, 2008, 2009; Cazzoli et al, 2009a, b). In brief, the continuous TBS protocol comprised 801 pulses, delivered in a continuous train and consisting of 267 bursts. Each burst contained 3 pulses at 30 Hz, repeated at 6 Hz. The total duration of 1 single, continuous TBS train was 44 seconds. Overall, 8 continuous TBS trains were applied over 2 days. Four continuous TBS trains were applied on Day 1 (2 continuous TBS trains with an interval of 15 minutes, third and fourth trains 60 and 75 minutes after first continuous TBS train, respectively; see Nyffeler et al, 2009), and 4 continuous TBS trains on Day 2 (same time intervals as for Day 1). Continuous TBS was applied over P3, according to the International 10–20 EEG System. This site overlies the posterior parietal cortex in proximity of the intraparietal sulcus (Hilgetag et al, 2001). The coil was held tangentially to the scalp, with the handle pointing posteriorly, the current flowing clockwise as viewed from above. Patients were asked to close their eyes during continuous TBS application. Continuous TBS was delivered at 100% of patients’ individual resting motor threshold. Sham was applied with the same protocol as described above, except for use of a sham coil (Magnetic Coil Transducer MC‐P‐B70) Control group received treatment as usual |
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Outcomes |
Measured immediately post treatment |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “were randomly allocated”. Split 16:8 could be lucky but suggests structure |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants | High risk | Blinding only within groups combined here |
Blinding of personnel | High risk | Not clear whether personnel blinded within combined groups, but not applicable to this combined comparison |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Assessment by “four independent raters who were responsible for the care of each particular patient”. Unclear how they could have been blinded for this combined comparison |
Incomplete outcome data (attrition bias) All outcomes | Low risk | “All patients included completed the study protocol…all patients were assessed with all tests”, with limited exceptions |
Selective reporting (reporting bias) | Low risk | All reported with equal (low) detail |
Other bias | Low risk | No evidence of this |