Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease

Study Overview
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Brief Summary
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We investigate the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) - video game-based training (VBT) dexterity intervention in Parkinson's diseases. The short and long-term benefits of this training program will be evaluated. For these purposes, a blinded sham controlled randomized controlled trial will be performed.

Detailed Description
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Patients with Parkinson's disease (PD) often exhibit dexterous difficulties during the performance of activities of daily living (ADL) such as tying shoe laces, hand-writing, using remote controls, smartphone or tablet. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation is exergaming. To enhance training effects a combination of repetitive transcranial magnetic stimulation (rTMS) with exergaming will be tested.

Official Title
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Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease: a Randomized Controlled Pilot-study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Transcranial magnetic stimulation
* Other: Sham transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed PD Hoehn & Yahr I to IV Age 50-80 years old written and signed informed consent dexterous difficulties- Exclusion Criteria: Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA < 21) Inability to understand the scope of the study and to follow study procedures according to the protocol e.g. complete questionnaires (i.e. due to cognitive problems) Exclusion criteria for TMS and Sham application, such as current pregnancy, personal history of epilepsy or epileptic fits, and any psychiatric, neurologic, or medical history. Participation in another interventional trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: blinded randomised clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: real stimulation<br>The PD patients randomized in the experimental group will receive VBT each time preceded by a real rTMS stimulation. | Other: Transcranial magnetic stimulation<br>* Non-invasive brain stimulation<br>|
| Sham Comparator: sham stimulation<br>The PD patients randomized in the control group will receive VBT each time preceded by a sham TMS. | Other: Sham transcranial magnetic stimulation<br>* Non-invasive brain stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DextQ-24 | standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nine Hole Peg test (9-HPT) | The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD. | 3 weeks | 
| Coin rotation task (CRT) | The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial magnetic stimulation, dexterity, video game-based training