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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867827
• Other study ID #: SPON997-11
• Status: Completed
• Phase: N/A
• First received: May 30, 2013
• Last updated: June 20, 2017
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: June 2017
• Source: Cardiff University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Neurofeedback and Physical Exercise

• Physical Exercise

Locations

Country	Name	City	State
United Kingdom	School of Medicine, Cardiff University	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Cardiff University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline in the 'Actigraph'		Change from baseline in the 'Actigraph' at 12 weeks
Secondary	Change from baseline in the 'GaitRite'		Change from baseline in the 'GaitRite' at 12 weeks

External Links

•   Paper reporting trial results