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

June 20, 2017 updated by: David Linden, Cardiff University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • School of Medicine, Cardiff University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Neurofeedback and Physical Exercise
Active Comparator: 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.
Other: Physical Exercise

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff University

Investigators

  • Principal Investigator: David Linden, MD, PhD, Cardiff University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPON997-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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