Skip to main content
. 2016 Mar 21;2016(3):CD009645. doi: 10.1002/14651858.CD009645.pub3

Ang 2012.

Methods Study design: RCT
Number of dropouts: none
Number of adverse effects: none (Ang 2015 [pers comm])
Deaths: none
ITT: yes
Participants Country: Singapore
Sample size: 19 participants; mean age (SD) 54 (10) years; mean UE‐FM (SD) 34 (8)
Inclusion criteria: not explicitly stated
Exclusion criteria: history of seizures; major depression; implants that interfered with tDCS; being able to operate an EEG‐based motor imagery brain‐computer interface (MI‐BCI); further therapy aiming at improving function in the affected upper limb
Interventions 2 arms:
  1. Dual‐tDCS with the anode placed over M1 of the affected hemisphere and the cathode placed over M1 the unaffected hemisphere (1 mA for 20 minutes) followed by 8 minutes of evaluation and 60 minutes of therapy using EEG‐based MI‐BCI with robotic feedback with the MIT‐Manus device 5 times a week for 2 weeks

  2. Sham tDCS with the anode placed over M1 of the affected hemisphere and the cathode placed over M1 the unaffected hemisphere (1 mA for 30 seconds) followed by 8 minutes of evaluation and 60 minutes of therapy using EEG‐based MI‐BCI with robotic feedback with the MIT‐Manus device 5 times a week for 2 weeks

Outcomes Outcomes were measured at baseline, at the end of intervention period at 2 weeks and at 2 week follow‐up:
  1. UE‐FM

  2. Online MI‐BCI performance

  3. event‐related desynchronisation laterality coefficient

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk People were randomised by "A randomization stratification generated using a computer‐generated random sequence" (Ang 2015 [pers comm])
Allocation concealment (selection bias) Unclear risk Quote: "Interventions of the subjects were applied by an engineer and a research assistant respectively. For tDCS, the research assistant was the only person who knew the randomization sequence for the subjects allocation" (Ang 2015 [pers comm])
Blinding of participants and personnel (performance bias) 
 Subjective outcome measures Low risk There were no subjective outcome measures
Blinding of participants and personnel (performance bias) 
 Objective outcome measures Low risk Participants were blinded; personnel were not blinded (Ang 2015 [pers comm])
Blinding of outcome assessment (detection bias) 
 Subjective outcome measures Low risk There were no subjective outcome measures
Blinding of outcome assessment (detection bias) 
 Objective outcome measures Low risk Quote: "Yes, the outcome assessors for Fugl‐Meyer were blinded to group allocation" (Ang 2015 [pers comm])
Incomplete outcome data (attrition bias) 
 Subjective outcome measures Low risk There were no subjective outcome measures
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) Unclear risk Not all of the secondary outcome measures listed in the published trial protocol have been reported, but will be presented in further publications (RMT of affected M1; grip strength; BBT; MRI parameters)