Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 30, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJune 21, 2017
June 1, 2017
10 months
May 30, 2013
June 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (2)
Neurofeedback and Physical Exercise
EXPERIMENTALThis 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.
Physical Exercise
ACTIVE COMPARATORThis 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.
Interventions
Eligibility Criteria
You may qualify if:
- People with Parkinson's Disease
- Hoehn and Yahr stages 1-3 of the disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Medicine, Cardiff University
Cardiff, Wales, CF14 4XN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Linden, MD, PhD
Cardiff University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Translational Neuroscience
Study Record Dates
First Submitted
May 30, 2013
First Posted
June 4, 2013
Study Start
March 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
June 21, 2017
Record last verified: 2017-06