Status:
UNKNOWN
Can tDCS Enhance Efficacy of Rehabilitative Intervention for Freezing of Gait in Parkinson's Disease?
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief Summary
Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and responds often incompletely to conventional therapy. The pathogenesis remains largely unknown and therapeutic ...
Eligibility Criteria
Inclusion
- men and women aged 30 to 80 years with DOPA-responsive PD Hoehn and Yahr (HY) grade of 2 to 4 while "off"
- must be on a regimen including levodopa
- total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
- Gait difficulties with Freezing of Gait as defined by MDS-UPDRS I score ≥ 2 in FOG
- Optimal conventional PD medication for \> 1 month prior to screening
- scheduled for rehabilitative intervention for the treatment of freezing of gait
Exclusion
- 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 such as an implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tDCS.
- Study would cause 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 meters.
- 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 (the physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview).
- presence of other co-morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
- presence of clinically significant hallucinations
- participation in any rehabilitation therapy for FOG within the last six months prior to screening
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02205216
Start Date
September 1 2014
Last Update
July 7 2015
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011