NCT02205216.

Trial name or title	Can transcranial direct stimulation enhance the efficacy of a rehabilitative intervention for the treatment of freezing of gait in Parkinson's disease? A double blind randomized controlled study
Methods	Randomised controlled trial
Participants	Estimated enrolment: 40 Inclusion criteria: aged 30 to 80 years; with DOPA‐responsive PD Hoehn and Yahr (HY) grade of 2 to 4 while off; on a regimen including levodopa (total dose of levodopa and dopamine agonists using dopamine equivalents > 300 mg/d; MDS‐UPDRS I score > 2 in Freezing of Gait; optimal conventional PD medication for > 1 month prior to screening; scheduled for rehabilitation for the treatment of freezing of gait Exclusion criteria: significant concurrent medical or psychiatric disease; history of seizures and epilepsy; dementia or other neurodegenerative disease besides PD; pallidotomy, implanted electrodes and generator for deep brain stimulation; pregnancy; surgically or traumatically implanted foreign bodies; undue risk or stress (for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness); significant postural instability with daily falls, inability to walk the parcours or inability to walk 10 metres ; presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MoCA) < 20 or mentally impaired patients having no capacity to provide their own consent; presence of other co‐morbid conditions that can contribute to gait dysfunction; clinically significant hallucinations; participation in any rehabilitation therapy for FOG within the last six months prior to screening
Interventions	2 arms: (1) A‐tDCS (2 mA for 20 minutes) over the motor and premotor cortex with cathodes placed over both mastoids during a 45‐minute rehabilitation session; 2 times a week for 4 weeks (2) S‐tDCS (1 mA for 1‐2 minutes) over the motor and premotor cortex with cathodes placed over both mastoids during a 45‐minute rehabilitation session; 2 times a week for 4 weeks
Outcomes	Outcomes will be recorded at baseline and at 1‐ month follow‐ up Primary outcome measures: Walking parcours Secondary outcome measures: New Freezing of Gait Questionnaire (N‐FOGQ) MDS‐UPDRS 39‐Item Parkinson's Disease Questionnaire (PDQ‐39) Beck Depression Inventory 10‐metre Walk Test Timed Up and GO
Starting date	September 2014
Contact information	David Benninger, MD Centre Hospitalier Universitaire Vaudois Lausanne, Vaud, Switzerland, 1011
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