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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Active Comparator | Active tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing. |
|
| Sham tDCS | Sham Comparator | Sham tDCS combined with a rehabilitative intervention consisting of cognitive training and sensory cueing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | anode over the motor and premotor cortex with cathodes placed over both mastoids. TDCS will be applied for 20 minutes at 2 mA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking parcours | 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. | from baseline to one month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| New Freezing of Gait Questionnaire (N-FOGQ) | NFOG-Q is a widely used and validated questionnaire for quantifying FOG severity and frequency in the daily living | from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention) |
| Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Benninger, MD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Sham tDCS | Device | anode and cathode placed 1 cm apart over the forehead and DC (1mA) applied for 1-2 min, short-circuited through the skin creating the same temporary "tingling" sensation without effects on the brain. |
|
| Rehabilitation Therapy | Behavioral | All patients will undergo a rehabilitation therapy intervention (2x a week for 4 weeks = 8 intervention sessions) with simultaneous sham or active tDCS. The trained physiotherapist will follow a standardized program with checklist. Each of the 8 training session will last approximately 45min. The rehabilitative interventions include:
|
|
| from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention) |
| 39-Item Parkinson's Disease Questionnaire (PDQ-39) | from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention) |
| Beck Depression Inventory (BDI) | from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention) |
| 10 Meter Walk Test (10MWT) | 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. | from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention) |
| Timed Up & GO (TUG) | 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. | from baseline to follow-up periods (immediately, 1 and 3 months after the last intervention) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |