Therapeutic Effects of Neurofeedback in Neurological Disorders

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000010723
• Date of registration: 15/06/2013
• Prospective Registration: Yes
• Primary sponsor: Dept. of Neurology, Osaka University Graduate School of Medicine
• Public title: Therapeutic Effects of Neurofeedback in Neurological Disorders
• Scientific title: Therapeutic Effects of Neurofeedback in Neurological Disorders - Therapeutic Effects of Neurofeedback in Neurological Disorders
• Date of first enrolment: 2014/01/17
• Target sample size: 180
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012307
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Phase II,III

Countries of recruitment

Japan

Contacts

• Name: Masahito Mihara
• Affiliation: Kawasaki Medical School Dept. of Neurology

• Name: Hideki Mochizuki
• Affiliation: Osaka University Graduate School of Medicine Dept. of Neurology

Key inclusion & exclusion criteria

Inclusion criteria:
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.

Age minimum: 20years-old
Age maximum: 85years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Parkinsonism Spinocerebellar Degeneration Stroke(with motor deficit[upper limb impairment/ gait and balance disorder]/ with speech dsyfunction)

Intervention(s)

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.
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

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Morinomiya Hospital Kawasaki Medical School

Ethics review

Status: YES
Approval date: 15/08/2013
Contact:

qqq@wwwwwww

Kawasaki Medical School

086-462-1111

qqq@wwwwwww

Results

• Results available: Yes
• Date Completed: 21/02/2019