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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010723
Receipt No. R000012307
Scientific Title Therapeutic Effects of Neurofeedback in Neurological Disorders
Date of disclosure of the study information 2013/06/15
Last modified on 2020/05/20

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Basic information
Public title Therapeutic Effects of Neurofeedback in Neurological Disorders
Acronym Therapeutic Effects of Neurofeedback in Neurological Disorders
Scientific Title Therapeutic Effects of Neurofeedback in Neurological Disorders
Scientific Title:Acronym Therapeutic Effects of Neurofeedback in Neurological Disorders
Region
Japan

Condition
Condition Parkinsonism
Spinocerebellar Degeneration
Stroke(with motor deficit[upper limb impairment/ gait and balance disorder]/ with speech dsyfunction)
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the therapeutic efficacy of Near-infrared spectropy mediated neurofeedback for the neurological disorders, including Parkinson disease, Spinocerebellar degeneration, and Stroke
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes for Parkinsonism: Timed-Up and go test
for Spinocerebellar degeneration:Timed-Up and go test
for Stroke with motor deficit:Timed-Up and go test
for Stroke with aphasia:Verbal Fluency test

Assessment timing:
Outcome measures were assessed at baseline, two weeks after(just after intervention completed), 4 weeks after(two weeks after intervention finished)
Statistical assessment:
unpaired T-test between groups comparing improvement from baseline to last observation.
Interaction between intervention and time course in repeated-measures ANOVA, with post-hoc analysis of group difference in improvement.
Key secondary outcomes for Parkinsonism:UPDRSpart3,Berg-balance scale, walking speed, Number of fall, other adverse effect
for Spinocerebellar degeneration:Scale for the assessment and rating of ataxia (SARA), Berg Balance Scale, number of falls, walking speed, 9holePEGtest, other adverse effect
for Stroke with motor deficit:Fugl-Meyer Scale, Berg-balance scale, walking speed, number of falls, other adverse effect
for Stroke with aphasia:Western Aphasia Battery(WAB), Standered Language Test for Aphasia(SLTA), other adverse effect

Assessment timing:
Outcome measures were assessed at baseline, two weeks after(just after intervention completed), 4 weeks after(two weeks after intervention finished)
Statistical assessment:
Interaction between intervention and time course in repeated-measures ANOVA, with post-hoc analysis of group difference in improvement.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Subjects are provideed feedback of cortical activity during task, and they are asked to try enhance their cortical activation during task.
After baseline clinical assessment, participant were provided Neurofeedback-based training three sessions per week for two weeks. In the Neurofeedback-basesd training, they were asked to imagine gait and balance related motorimagery, and the cortical activation signal were provided as feedback. All participants were provided usual rehabilitative intervention up to 180 min per day for more than 5 times per week, until two weeks passes after neurofeedback intervention were finished.
In patients participated study for gait disturbance as primary outcome, daily therapy should include at least 60 minutes of physical therapy. In patients participated study for upper limb paresis as outcome measures, daily therapy should include at least 60 minutes of occupational therapy. In patients participated study for aphasia as primary outcome measures, daily therapy should include at least 60 minutes of speech therapy.
Interventions/Control_2 Subjects are asked to try enhance their cortical activation during task, but they are provideed cortical activity from other subject. (Control)
After baseline clinical assessment, participant were provided Neurofeedback-based training three sessions per week for two weeks. In the Neurofeedback-basesd training, they were asked to imagine gait and balance related motorimagery, and the cortical activation signal were provided as feedback. All participants were provided usual rehabilitative intervention (including at least 60 minutes of physical and/or occupational therapy) up to 180 min per day for more than 5 times per week, until two weeks passes after neurofeedback intervention were finished.
In patients participated study for gait disturbance as primary outcome, daily therapy should include at least 60 minutes of physical therapy. In patients participated study for upper limb paresis as outcome measures, daily therapy should include at least 60 minutes of occupational therapy. In patients participated study for aphasia as primary outcome measures, daily therapy should include at least 60 minutes of speech therapy.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients meet all criteria described below are enrolled.
1) Age: 20 years or more, and 85 years or less
2) Written informed consent is obtained.
3) Fulfilled one of the following criteria
peech disturbance.
1. Patients with Parkinsonism
Patients showed at least two of the following; bradykinesia, rigidity, tremor, postural instability.
2. Patients with Spinocerebellar degeneration:
Patients showed progressive cerebellar ataxia with the course of more than 6 months. Patients with secondary cerebellar ataxia due to tumor, vascular accident, and metabolic disorders are excluded.
3. Patients with Stroke representing motor disturbance:
Patients who are suffered from first episode of cerebral infarction or intracerebral hemorrhage, and showed persistent motor disturbance.(obvious at the 12 weeks from onset)
4. Patients with Stroke representing motor disturbance:
Patients who are suffered from first episode of cerebral infarction or intracerebral hemorrhage, and showed persistent speech dysfunction (obvious at the 12 weeks from onset).
Key exclusion criteria Exclusion criteria includes:
1) severe cognitive dysfunction (MMSE<20).
2) severe carotid or intracerebral arterial stenosis (ICAstenosis>90% or MCA/ACA/PCA stenosis >75%)
3) Patients with large cortical lesion (> 1/3 of MCA territory).
4) unstable general condition.
5) undiagnosed patients.
6) with poor visual acuity (<0.05)
7) unable to understand examiners' order
8) with severe infection.
9) with scalp dermatitis
10) pregnant or lactating woman
11) being considered not to be enrolled in this study by attending physician.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Mochizuki
Organization Osaka University Graduate School of Medicine
Division name Dept. of Neurology
Zip code 565-0871
Address 2-2 d4 Yamadaoka Suita, Osaka
TEL 06-6879-3571
Email hmochizuki@neurol.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Masahito
Middle name
Last name Mihara
Organization Kawasaki Medical School
Division name Dept. of Neurology
Zip code 7010192
Address 577 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Homepage URL
Email mihara@neurol.med.osaka-u.ac.jp

Sponsor
Institute Dept. of Neurology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization the Japan Agency for Medical Research and development (AMED).

Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Morinomiya Hospital
Kawasaki Medical School
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kawasaki Medical School
Address 577 matsushima Kurashiki
Tel 086-462-1111
Email qqq@wwwwwww

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪大学医学部附属病院(大阪府)
森之宮病院(大阪府)
川崎医科大学(岡山県)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 117
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Papers under revision
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 04 Month 15 Day
Date of IRB
2013 Year 08 Month 15 Day
Anticipated trial start date
2014 Year 01 Month 17 Day
Last follow-up date
2019 Year 02 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 15 Day
Last modified on
2020 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012307

Research Plan
Registered date File name
2020/05/20 Protocol_english_for ref only.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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