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

NCT ID: NCT01867827

Last Updated: 2017-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Neurofeedback and Physical Exercise

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Physical Exercise

Intervention Type OTHER

Interventions

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Neurofeedback and Physical Exercise

Intervention Type OTHER

Physical Exercise

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiff University

OTHER

Sponsor Role lead

Responsible Party

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David Linden

Professor of Translational Neuroscience

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Linden, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiff University

Locations

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School of Medicine, Cardiff University

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://doi.org/10.3389/fnbeh.2016.00111

Paper reporting trial results

Other Identifiers

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SPON997-11

Identifier Type: -

Identifier Source: org_study_id

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