Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01867827
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
David Linden, 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Neurofeedback and Physical Exercise Other: Physical Exercise Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease
Study Start Date : March 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. Change from baseline in the 'Actigraph' [ Time Frame: Change from baseline in the 'Actigraph' at 12 weeks ]
  4. Change from baseline in the 'GaitRite' [ Time Frame: Change from baseline in the 'GaitRite' at 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867827


Locations
Layout table for location information
United Kingdom
School of Medicine, Cardiff University
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
Cardiff University
Investigators
Layout table for investigator information
Principal Investigator: David Linden, MD, PhD Cardiff University

Additional Information:
Layout table for additonal information
Responsible Party: David Linden, Professor of Translational Neuroscience, Cardiff University
ClinicalTrials.gov Identifier: NCT01867827     History of Changes
Other Study ID Numbers: SPON997-11
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases