Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease

Study Overview
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Brief Summary
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The aim of the study is to train patients with Parkinson's Disease to increase activity in a brain area that is involved in the control of motor functions with the use of a technique called real-time fMRI neurofeedback (NF) along with regular physical exercise. This will be a randomised and controlled clinical trial to evaluate the benefits of a novel treatment. The investigators expect NF training along with physical exercise practise to better improve motor functions compared to physical exercise alone.

Official Title
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Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Neurofeedback and Physical Exercise
* Other: Physical Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with Parkinson's Disease Hoehn and Yahr stages 1-3 of the disease Exclusion Criteria: Patients with dementia or significant comorbidity those who fail the safety screening to go into an MRI scanner those who cannot travel to the University
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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback and Physical Exercise<br>This group will undergo neurofeedback intervention in the fMRI scanner in weeks 1,5 and 12. They will also undergo physical exercise training on WiiFit device once a week after the first month till the end of the study at 12 weeks. | Other: Neurofeedback and Physical Exercise<br> <br> |
| Active Comparator: Physical Exercise<br>This group will undergo Physical Exercise intervention on the WiiFit device 3 times a week in the first month and once a week after the first month till the end of the study at 12 weeks. | Other: Physical Exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the 'Movement Disorder Society - Unified Parkinson's Disease Rating Scale' (MDS-UPDRS) |  | Change from Baseline in the 'Movement Disorder Society - Unified Parkinson's Disease Rating Scale' (MDS-UPDRS) in 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39) |  | Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39) at 4 weeks | 
| Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39) |  | Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39) in 12 weeks | 
| Change from baseline in the 'Actigraph' |  | Change from baseline in the 'Actigraph' at 12 weeks | 
| Change from baseline in the 'GaitRite' |  | Change from baseline in the 'GaitRite' at 12 weeks |