Can tDCS Enhance Efficacy of Rehabilitative Intervention for Freezing of Gait in Parkinson's Disease?

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Device: Sham tDCS; Device: Active tDCS; Behavioral: Rehabilitation Therapy

• Registration Number: NCT02205216
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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 alternatives are needed. Rehabilitative interventions that consist of learning cognitive strategies with sensory cueing to prevent and to overcome FOG represent the most efficacious intervention, but difficulties in learning and execution of these cognitive strategies are the main cause of failure. Transcranial direct current stimulation (tDCS) enhances motor task learning and execution in patients with PD and might enhance the efficacy of rehabilitative interventions.

This study intends to address the following question whether tDCS can enhance the efficacy of rehabilitative interventions in the treatment of freezing of gait in Parkinson's disease?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Study Start: 2014-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-03
• Last Update Posted: 2015-07-07
• Primary Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Rehabilitation Therapy	Active tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
Sham tDCS	Sham tDCS	Sham tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
Active tDCS	Active tDCS	Active tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.
Sham tDCS	Rehabilitation Therapy	Sham tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing.

Primary Outcome Measures

Name	Time	Method
Walking parcours	from baseline to one month follow-up	This standardized parcours, performed under guidance of a physiotherapist, includes real-life conditions which are known to precipitate freezing. Time needed to perform the parcours and number of FOG episodes will be assessed.

Secondary Outcome Measures

Name	Time	Method
39-Item Parkinson's Disease Questionnaire (PDQ-39)	from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)
New Freezing of Gait Questionnaire (N-FOGQ)	from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)	NFOG-Q is a widely used and validated questionnaire for quantifying FOG severity and frequency in the daily living
Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)
10 Meter Walk Test (10MWT)	from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)	10MWT measures the time taken and the number of steps needed to walk a 10-meter distance from a standing position. Gait testing includes three averaged trials.
Timed Up & GO (TUG)	from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)	TUG requires patients to get up of a standard armed-chair, to walk 3 meters away, to turn around a cone, to walk back and to sit down.
Beck Depression Inventory (BDI)	from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland