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. 2016 Mar 21;2016(3):CD009645. doi: 10.1002/14651858.CD009645.pub3

Di Lazzaro 2014a.

Methods Study design: RCT
Number of dropouts: none
Number of adverse effects: not reported
Deaths: none
ITT: yes
Participants Country: Italy
Sample size: 14 (7 in the experimental and 7 in the control group)
Inclusion criteria: first ischaemic cerebral infarction confirmed by MRI; admitted to Stroke Unit; aged between 18 to 90 years; acute phase of stroke
Exclusion criteria: prestroke disability; not understanding instructions for motor testing; excessive pain in any joint of the paretic limbs; contraindications to single‐pulse TMS; advanced diseases of inner organs; concurrent neurologic or psychiatric diseases; history of substance abuse; use of neuropsychotropic drugs
Interventions 2 arms
  1. Bilateral tDCS (anode over M1 of the lesioned hemisphere and cathode over M1 of the non‐lesioned hemisphere, simultaneously) (2 mA for 40 minutes) for 5 continuous days

  2. Sham tDCS (anode over M1 of the lesioned hemisphere and cathode over M1 of the non‐lesioned hemisphere, simultaneously) (2 mA for 30 seconds) for 5 continuous days

Outcomes Outcomes were measured at baseline and at the end of intervention period
  1. Action Research Arm Test

  2. 9 Hole Peg Test

  3. Handgrip strength

  4. Motor Activity Log Scale

  5. National Institute of Health Stroke Scale

  6. Modified Rankin Scale

  7. Adverse event monitoring and reporting

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomized to real or sham tDCS treatment through a block randomization stratification approach"
Allocation concealment (selection bias) Unclear risk Not described by the authors
Blinding of participants and personnel (performance bias) 
 Subjective outcome measures Low risk Participants and personnel were blinded; quote "The investigators who applied real/sham tDCS were kept blind to the intervention by using the pre‐programmed stimulation mode in the stimulator settings"
Blinding of participants and personnel (performance bias) 
 Objective outcome measures Low risk Participants and personnel were blinded; quote "The investigators who applied real/sham tDCS were kept blind to the intervention by using the pre‐programmed stimulation mode in the stimulator settings"
Blinding of outcome assessment (detection bias) 
 Subjective outcome measures Low risk Quote: "An evaluator, blinded to the treatment, assessed the effects of the intervention"
Blinding of outcome assessment (detection bias) 
 Objective outcome measures Low risk Quote: "An evaluator, blinded to the treatment, assessed the effects of the intervention."
Incomplete outcome data (attrition bias) 
 Subjective outcome measures Low risk All participants apparently completed the study. No treatment withdrawals, no losses to follow‐up, no trial group changes and no major adverse events were stated
Incomplete outcome data (attrition bias) 
 Objective outcome measures Low risk All participants apparently completed the study. No treatment withdrawals, no losses to follow‐up, no trial group changes and no major adverse events were stated
Selective reporting (reporting bias) High risk All outcomes listed in the methods section reported except 'Adverse events', which was not reported clearly