Back to resultsReal-time fMRI Neurofeedback for Treatment of Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Neurofeedback and Physical Exercise
Physical Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
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
Sites / Locations
- School of Medicine, Cardiff University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neurofeedback and Physical Exercise
Physical Exercise
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from Baseline in the 'Movement Disorder Society - Unified Parkinson's Disease Rating Scale' (MDS-UPDRS)
Secondary Outcome Measures
Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39)
Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39)
Change from baseline in the 'Actigraph'
Change from baseline in the 'GaitRite'
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01867827
Brief Title
Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease
Official Title
Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiff University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback and Physical Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neurofeedback and Physical Exercise
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Primary Outcome Measure Information:
Title
Change from Baseline in the 'Movement Disorder Society - Unified Parkinson's Disease Rating Scale' (MDS-UPDRS)
Time Frame
Change from Baseline in the 'Movement Disorder Society - Unified Parkinson's Disease Rating Scale' (MDS-UPDRS) in 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39)
Time Frame
Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39) at 4 weeks
Title
Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39)
Time Frame
Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39) in 12 weeks
Title
Change from baseline in the 'Actigraph'
Time Frame
Change from baseline in the 'Actigraph' at 12 weeks
Title
Change from baseline in the 'GaitRite'
Time Frame
Change from baseline in the 'GaitRite' at 12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Linden, MD, PhD
Organizational Affiliation
Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine, Cardiff University
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://doi.org/10.3389/fnbeh.2016.00111
Description
Paper reporting trial results
Learn more about this trial
Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease
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