Neurofeedback with Gait imagery for PD

JRCT ID: jRCTs062220027

Registered date:08/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson Disease
• Date of first enrollment: 18/01/2023
• Target sample size: 50
• Study type: Interventional

Intervention(s)

In This study, participants asked to perform motor imagery training with neurofeedback, which provided as visual indicator based on the brain activities measured by the near-infrared spectroscopy mediated neurofeedback system (NIRS-NFB). this intervention consist of 4 training session per week for 4 weeks.
Participants would perform motor imagery training after waring this NIRS-NFB system attached to their head. In each session, participants asked to perform two different task sets, consist of rising-up from the chair task and walking along task. Each task is consisted of several 5 seconds imagery periods and pseudo-randomized 8-16 seconds rest periods. They are asked to perform motor imagery task only during the imagery periods, and stay calm during rest periods. Each intervention session contains less than 30 minurtes of imagery training and lasts within 40 minutes

Outcome(s)

• Primary Outcome: 10m walk test
• Secondary Outcome: 10m walk test, MDS-UPDRS, Mini-BESTest, 3m-Timued Up and Go test, FOGQ, PDQ8, number of falls, any adverse effect

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) patients who had written informed consent
2) age older than 39 year old
3) PD patients with diagnosis of clinically probable or clinically established PD in MDS criteria
4) Patients with Hoehn-Yahr stage 2 to 4
5) Patients who can walk 10 m safely with or without aid
6) Patients whose anti-Parkinsonian drug is not changed for at least 2 months at the time of registration
7) Patients who can understand the verbal order and perform task

Exclude criteria

1) moderate to severe dmentia with MMSE score< 22
2) Patients with cortical lesion covering media premotor area including the supplementary motor area
3) Patients with history of symptomatic stroke or Epilepsy
4) patients with severe Anterior Cerebral Artery stenosis (>90%)
5) Patients wiht history of neurosurgical operation including Deep brain stimulation and trans-arterialaneurysm coil embolization)
6) Patients unstable in vital signs
7) Patients with corrected binocular visual acuity less than 1/20
8) Patients with scalp lesion which needed treatment
9) Women with Pregnancy, lactating, or suspected pregnancy
10) Patients who is unable to perform brain MRI scannning
11) Patients with past or current history of clinically established psychological illness (needs wnti-psychotic drugs).
12) Patients have experienced experimental brain stimulation intervention (including repetitive trans
cranial magnetic stimuration or transcranial direct/alternative current stimulation) within 6 months prior to the enrollment.
13) Patients with severe, unpredicable wearing-off which disturb stable evaluation in each visit
14) Patients with muscloskeltal complication which affect gait performance
15) Patients assumed to be inadequate fore enrollment by their attending physician

Related Information

• Primary Sponsor: Mihara Masahito
• Source(s) of Monetary Support: Japan Society for the Promotion of Science Secondary Sponsor