NCT05800470

The Effects of fNIRS-based Neurofeedback Training on Balance and Gait in Parkinson's Disease

The Novel Application of fNIRS-based Neurofeedback to Enhance Effects of Motor Imagery on Balance and Gait Performance in Individuals With Parkinson's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: National Yang Ming Chiao Tung University · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

Summary

A cross-sectional study (part 1) aims to investigate the influence of fatigue on the MI ability in PD compared to healthy controls. A randomized controlled trial (part 2) aims to compare the effect of fNIRS-based NFB-MI on balance and gait performance versus MI only in people with PD.

Detailed description

To fulfill out study purposes, a cross-sectional study (Part I) and an interventional randomized controlled trial (Part II) are designed. In Part I, people with PD and the age-matched healthy controls will be recruited and perform imagery and actual walking tasks. The level of general fatigue will be measured by Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) in people with PD. The level of concurrent fatigue will be induced by 30-minute cognitive tasks consisting of A-X continuous performance test, 2 back and mental rotation test and will be assessed by Brunel Mood Scale (BRUMS-C) in people with PD. Independent t test will be used to compare the MI ability between PD group and healthy control group. The Pearson's correlation coefficient will be used to examine the relationships between general fatigue level (MFI) and MI ability and between concurrent fatigue level (BRUMS) and MI ability in people with PD. In Part II, people with PD will be randomly allocated to either NFB-MI, MI or MT group. Every participant will receive 12 sessions of training in four weeks. NFB-MI and MI training will consist of 20-min MI with or without neurofeedback respectively followed by 20-min of balance and gait training. In the MT group, participants will receive 40-min of balance and gait training. Outcome measures, including Mini Balance Evaluation Systems Test (Mini-BEST), Timed up-and-go test (TUG), gait performance, will be assessed at pre-, post-test, and follow-up. MI ability and fatigue will be assessed at pre-, mid-and post-test. A two-way analysis of variance (ANOVA) with repeated measure will be used to determine the time by group interaction for all the outcomes. Post hoc test with Bonferroni correction will be applied for significant interaction. Significant level for part I and part II will be set at p \< 0.05.

Conditions

• Parkinson Disease
• Movement Disorder, Functional

Interventions

Type	Name	Description
OTHER	fNIRS-based neurofeedback with motor imagery	A multichannel wearable fNIRS (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) will be used to detect the cortical activity in SMA. The HbO concentration will be processed and displayed as a visual feedback during MI training.
OTHER	Kinesthetic motor imagery	Prior to each task, participants will watch a video of a person executing balance tasks and walking tasks. The balance tasks will include static and dynamic standing tasks such as sit-to-stand, tandem stance, standing on a balance board, reaching out to different directions and single leg stance. The walking tasks consists of tandem walking, crossing obstacles, sideward walking, backward walking, and turning. The participants will be asked to kinesthetically imagine movements in the first-person perspective, and the researcher will give the explicit instruction encouraging them to focus on the feeling (i.e. tactile, proprioceptive and kinesthetic sensations). Each MI session consists of 10-min of balance tasks and 10-min of walking tasks.
OTHER	Motor training	The tasks for balance and gait training are similar to those during the MI training. The difficulty of the tasks will be modified individually for each participant. The researcher will ensure the safety.

Timeline

• Start date: 2025-03-19
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-04-05
• Last updated: 2025-08-07

Locations

1 site across 1 country: Taiwan