Parkinson's DiseaseNCT01867827
Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease
A study testing Neurofeedback and Physical Exercise and Physical Exercise in people with Parkinson's Disease, run by Cardiff University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Neurofeedback and Physical Exercise and Physical Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People with Parkinson's Disease
- Hoehn and Yahr stages 1-3 of the disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Medicine, Cardiff University
Cardiff, Wales, CF14 4XN
About this study
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.
- Conditions
- Parkinson's Disease
- Being tested
- Neurofeedback and Physical Exercise, Physical Exercise
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback and Physical ExerciseOther
Physical ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback and Physical Exercise | Experimental | 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. Receives: Other: Neurofeedback and Physical Exercise |
| Physical Exercise | Active comparator | 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. Receives: Other: Physical Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the 'Movement Disorder Society - Unified Parkinson's Disease Rating Scale' (MDS-UPDRS)
Measured: Change from Baseline in the 'Movement Disorder Society - Unified Parkinson's Disease Rating Scale' (MDS-UPDRS) in 12 weeks
Secondary outcomes (4)
Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39)
Measured: 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)
Measured: Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39) in 12 weeks
Change from baseline in the 'Actigraph'
Measured: Change from baseline in the 'Actigraph' at 12 weeks
Change from baseline in the 'GaitRite'
Measured: Change from baseline in the 'GaitRite' at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Linden, Cardiff University
- Investigators
- David Linden, MD, PhD, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867827
- Sponsor's protocol ID
- SPON997-11
- Status last verified
- Jun 2017
- First submitted
- 30 May 2013
- Last updated
- 21 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01867827
- Acronym / sponsor ID
- SPON997-11
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback and Physical Exercise | Experimental | Other: Neurofeedback and Physical ExerciseThis 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. |
| Physical Exercise | Active comparator | Other: Physical ExerciseThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- People with Parkinson's Disease
- Hoehn and Yahr stages 1-3 of the disease
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback and Physical Exercise | Other | Neurofeedback and Physical Exercise |
| Physical Exercise | Other | Physical Exercise |
Primary outcome
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
4 secondary outcomes
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)
Time frame: 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 'GaitRite'
Time frame: Change from baseline in the 'GaitRite' at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Paper reporting trial resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Linden, MD, PhD principal investigator
Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback and Physical Exercise and Physical Exercise in people with Parkinson's Disease, run by Cardiff University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.