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

Official title

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

Overview

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.

Interventions

• 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
• 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.

Primary outcome measures

• Self-perceived fatigue for general fatigue level [Time frame: Part 1 cross-sectional assessment (day 1 of the study)]
• Motor imagery ability [Time frame: Part 1 cross-sectional assessment (day 1 of the study and day 8 for second assessment)]
• Kinesthetic and visual imagery ability [Time frame: Part 1 cross-sectional assessment (day 1 of the study and day 8 for second assessment)]
• Self-perceived fatigue for concurrent fatigue level [Time frame: Part 1 cross-sectional assessment (day 8 of the study)]
• Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to post-test [Time frame: Part 2 pre-test, post-test (4 weeks)]
• Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to follow-up [Time frame: Part 2 pre-test and 4-week follow-up assessment (8 weeks)]
• Change of Timed up-and-go test (TUG) from pre-test to post-test [Time frame: Part 2 pre-test and post-test (4 weeks)]
• Change of Timed up-and-go test (TUG) from pre-test to follow-up [Time frame: Part 2 pre-test and 4-week follow-up assessment (8 weeks)]
• Change of gait performance from pre-test to post-test [Time frame: Part 2 pre-test and post-test (4 weeks)]
• Change of gait performance from pre-test to follow-up [Time frame: Part 2 pre-test and 4-week follow-up assessment (8 weeks)]

Secondary outcome measures (6)

• Change of self-perceived fatigue from pre-test to mid-test [Time frame: Part 2 pre-test and mid-test (2 weeks)]
• Change of self-perceived fatigue from pre-test to post-test [Time frame: Part 2 pre-test and post-test (4 weeks)]
• Change of motor imagery ability from pre-test to mid-test [Time frame: Part 2 pre-test and mid-test (2 weeks)]
• Change of motor imagery ability from pre-test to post-test [Time frame: Part 2 pre-test and post-test (4 weeks)]
• Change of kinesthetic and visual imagery ability from pre-test to mid-test [Time frame: Part 2 pre-test and mid-test (2 weeks)]
• Change of kinesthetic and visual imagery ability from pre-test to post-test [Time frame: Part 2 pre-test and post-test (4 weeks)]

Eligibility criteria

Part 1

Additional Inclusion Criteria for PD:

• diagnosis of idiopathic PD by neurologist with Hoehn and Yahr stage < 4;
• stable medical condition;
• capability of walking independently without walking devices.

Exclusion criteria

• cognitive impairment indicated by MMSE score < 24;
• motor imagery ability indicated by KVIQ score < 25;
• unable recognize 26 letters in the English alphabet
• history of diseases or conditions known to interfere with participating this study (e.g. epilepsy, metal implants in the brain, or deep brain stimulation);
• diagnosis of any other neurological disease or psychiatric disorder (e.g. stroke, anxiety disorder, or depression);
• using central nervous system medications other than for PD, e.g. antiepileptic drugs in recent 3 months.

Part 2

Inclusion criteria

• aged 40-85 y/o;
• diagnosis of idiopathic PD by neurologist with Hoehn and Yahr stage < 4;
• stable medical condition;
• capability of walking independently for 10 minutes, which is the time needed for imagery walking training in order to eliminate the possible influence of physical fatigue.

Exclusion criteria

• cognitive impairment indicated by MMSE score < 24;
• history of diseases or conditions known to interfere with participating this study (e.g. epilepsy, metal implants in the brain, or deep brain stimulation);
• diagnosis of any other neurological disease or psychiatric disorder (e.g. stroke, anxiety disorder, or depression);
• using central nervous system medications other than for PD, e.g. antiepileptic drugs in recent 3 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Taiwan · 1 center

• National Yang Ming Chiao Tung University — Taipei

Identifiers

NCT: NCT05800470 · NYCU112020AE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗