Parkinson DiseaseNCT03837548
A Study of Neurofeedback for the Treatment of Parkinson's Disease
A study testing Training with Neurofeedback and The other Training with Neurofeedback in people with Parkinson Disease, run by Osaka University at 1 site in Japan.
Trial summary
This study aims to reveal relationship between brain activities and the symptoms of Parkinson disease when a neurofeedback training was applied for them. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Training with Neurofeedback and The other Training with Neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2019to 31 Mar 2022
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with age more than 20
- Subjects obtained the consent
- Subjects with Parkinson disease and healthy subjects
Who cannot join
- The subjects who can not conduct the tasks
- Subjects with severe illness
- Subjects whom the experimenter think as in appropriate
- Subjects with implantable devices such as pacemaker
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Osaka University
Suita, Osaka, 5650871
Takufumi Yanagisawa, Ph.D., +81-6-6879-3652, tyanagisawa@nsurg.med.osaka-u.ac.jp
About this study
Official title: A Phase 1 Double-Blind Crossover Comparative Study of Neurofeedback for the Treatment of Parkinson's Disease
This study aims to reveal relationship between brain activities and the symptoms of Parkinson disease when a neurofeedback training was applied for them.
- Conditions
- Parkinson Disease
- Being tested
- Training with Neurofeedback, The other Training with Neurofeedback
- Keywords
- Parkinson's Disease, Magnetoencephalography, Neurofeedback
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with NeurofeedbackOther
Neurofeedback the brain activities by Magnetoencephalography
The other Training with NeurofeedbackOther
Neurofeedback the brain activities by Magnetoencephalography
| Study group | Role | What they receive |
|---|---|---|
| Training with Neurofeedback | Experimental | Not described Receives: Other: Training with Neurofeedback |
| The other Training with Neurofeedback | Experimental | Not described Receives: Other: The other Training with Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alteration of Brain Activities
measured by magnetoencephalography
Measured: At the time Immediately following the training
Secondary outcomes (1)
The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part Ⅲ scores
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
The total score is the sum of the subscale scores for Part III and ranges from 0 (no disability) to 132 (total dependence).
Measured: At the time Immediately following the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Jun 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837548
- Sponsor's protocol ID
- 18027-2
- Other IDs
- UMIN000032937
- Status last verified
- Aug 2019
- First submitted
- 15 Jan 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Izutsu N, Yanagisawa T, Fukuma R, Kishima H. Magnetoencephalographic neurofeedback training decreasesbeta-low-gammaphase-amplitude coupling of the motor cortex of healthy adults: a double-blinded randomized crossover feasibility study. J Neural Eng. 2023 May 9;20(3). doi: 10.1088/1741-2552/acd0d6.
PubMed 37105162
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-Blind Crossover Comparative Study of Neurofeedback for the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03837548
- Acronym / sponsor ID
- 18027-2
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Magnetoencephalography, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 12 Feb 2019 (actual)
- 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.
This study aims to reveal relationship between brain activities and the symptoms of Parkinson disease when a neurofeedback training was applied for them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training with Neurofeedback | Experimental | Other: Training with Neurofeedback |
| The other Training with Neurofeedback | Experimental | Other: The other Training with Neurofeedback |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with age more than 20
- Subjects obtained the consent
- Subjects with Parkinson disease and healthy subjects
Key exclusion criteria (4 listed)
- The subjects who can not conduct the tasks
- Subjects with severe illness
- Subjects whom the experimenter think as in appropriate
- Subjects with implantable devices such as pacemaker
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 |
|---|---|---|
| Training with NeurofeedbackNeurofeedback the brain activities by Magnetoencephalography | Other | Training with Neurofeedback |
| The other Training with NeurofeedbackNeurofeedback the brain activities by Magnetoencephalography | Other | The other Training with Neurofeedback |
Primary outcome
Alteration of Brain Activities
Time frame: At the time Immediately following the training
measured by magnetoencephalography
1 secondary outcome
The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part Ⅲ scores
Time frame: At the time Immediately following the training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Derived from this study: PubMed 37105162Izutsu N, Yanagisawa T, Fukuma R, Kishima H. Magnetoencephalographic neurofeedback training decreasesbeta-low-gammaphase-amplitude coupling of the motor cortex of healthy adults: a double-blinded randomized crossover feasibility study. J Neural Eng. 2023 May 9;20(3). doi: 10.1088/1741-2552/acd0d6.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with Neurofeedback and The other Training with Neurofeedback in people with Parkinson Disease, run by Osaka University at 1 site in Japan.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Sep 2019. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takufumi Yanagisawa, Ph.D. (+81-6-6879-3652, tyanagisawa@nsurg.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alteration of Brain Activities (time frame: At the time Immediately following the training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03837548, which also lists 1 linked publication.
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 11 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.