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Completed

NCT Number: NCT01867827

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine, Cardiff University

Cardiff, Wales, CF14 4XN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurofeedback and Physical Exercise

Other

Physical exercise

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cardiff University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2013
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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