| Methods |
Randomised cross‐over trial
Method of randomisation: not described
Blinding of outcome assessors: not described
Adverse events: none
Deaths: none
Dropouts
: none
ITT: yes |
| Participants |
Country: Italy
10 patients
Mean age: 72 years
Inclusion criteria: diagnosis of PD according to UK PD Brain Bank criteria, Hoehn
and Yahr stage 2 to 4 while “off” medication, Freezing of Gait Questionnaire (FOG‐Q) > 3 and freezing of gait (FOG) in
'on'
and
'off'
state, written informed consent
Exclusion criteria: contraindications to tDCS |
| Interventions |
Each participant underwent the following conditions (with a washout
period of three months):
(A) five consecutive sessions of sham tDCS, (2 mA for 20 minutes) over M1 of the leg with which the patient usually started walking after a FOG episode
(B) five consecutive sessions of anodal tDCS, 2 mA for 1 minute, over M1 of the leg with which the patient usually started walking after a FOG episode |
| Outcomes |
The following outcomes were recorded at baseline, and after the 1st and 5th treatment session of the two treatment blocks, 2 days and 2 and 4 weeks after the last tDCS session:
Italian validated Movement Disorders Society revision of the Unified Parkinson’s Disease Rating
Scale (MDS‐UPDRS) (impairment)
Stand Walk Sit (SWS) test (freezing of gait)
The following outcomes were recorded at baseline, 2 days and 2 and 4 weeks after the last tDCS session
FOG‐Q and Gait and falls questionnaire (gait, falls, freezing of gait episodes) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding of participants and personnel (performance bias)
Objective outcomes |
Low risk |
Participants apparently were blinded, but blinding of personnel not stated |
| Blinding of participants and personnel (performance bias)
Subjective outcomes |
Unclear risk |
Participants apparently were blinded, but blinding of personnel not stated |
| Blinding of outcome assessment (detection bias)
Objective outcomes |
Unclear risk |
No blinding of outcome assessors stated |
| Blinding of outcome assessment (detection bias)
Subjective outcomes |
High risk |
No blinding of outcome assessors stated |
| Incomplete outcome data (attrition bias)
Subjective outcomes |
Low risk |
No dropouts occurred |
| Selective reporting (reporting bias) |
Unclear risk |
All outcomes reported in the "methods" section have been reported; no protocol could be identified |
