UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Dept. of Neurology, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Morinomiya Hospital
Kawasaki Medical School

Name of secondary funder(s)

Organization

Kawasaki Medical School

Address

577 matsushima Kurashiki

Tel

086-462-1111

Email

qqq@wwwwwww

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

06

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Main results already published

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 related information

Registered date

2013

Year

05

Month

15

Day

Last modified on

2022

Year

11

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012307