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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Physical Exercise; Other: Neurofeedback and Physical Exercise

• Registration Number: NCT01867827
• Lead Sponsor: Cardiff University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-04
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Exercise	Physical Exercise	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.
Neurofeedback and Physical Exercise	Neurofeedback and Physical Exercise	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

School of Medicine, Cardiff University; 🇬🇧 Cardiff, Wales, United Kingdom