Clinical trial NCT05800470: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Movement Disorder, Functional
Keywords: Neurofeedback
Motor imagery
Parkinson's disease
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1: A cross-sectional study aims to investigate the influence of fatigue on the MI ability in PD compared to healthy controls Part 2: A randomized controlled trial compare the effect of fNIRS-based NFB-MI on balance and gait performance versus MI only in people with PD.
Primary purpose: OTHER

Brief 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 or MI group. Every participant will receive 12 sessions including three lab-visit sessions and nine home-bases training sessions. Each session consists of 10 min of MI, followed by 20 min of exercise focusing on balance and gait ability. During the lab-visit sessions, participants in experimental group will receive 10 minutes of NFB-MI. Outcome measures, including Mini Balance Evaluation Systems Test (Mini-BEST), Timed up-and-go test (TUG), gait performance, MI ability and fatigue, will be assessed at pre-, post-test, and follow-up. 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.

Eligibility criteria: Part 1

Additional Inclusion Criteria for PD:

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

Exclusion Criteria:

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

Part 2

Inclusion Criteria:

1. aged 40-85 y/o;
2. diagnosis of idiopathic PD by neurologist with Hoehn and Yahr stage \< 4;
3. stable medical condition;
4. 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:

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

Primary outcomes:
measure: Self-perceived fatigue for general fatigue level
timeFrame: Part 1 cross-sectional assessment (day 1 of the study)
measure: Motor imagery ability
timeFrame: Part 1 cross-sectional assessment (day 1 of the study and day 8 for second assessment)
measure: Kinesthetic and visual imagery ability
timeFrame: Part 1 cross-sectional assessment (day 1 of the study and day 8 for second assessment)
measure: Self-perceived fatigue for concurrent fatigue level
timeFrame: Part 1 cross-sectional assessment (day 8 of the study)
measure: Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to post-test
timeFrame: Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
measure: Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to follow-up
timeFrame: Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
measure: Change of Timed up-and-go test (TUG) from pre-test to post-test
timeFrame: Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
measure: Change of Timed up-and-go test (TUG) from pre-test to follow-up
timeFrame: Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
measure: Change of gait performance from pre-test to post-test
timeFrame: Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
measure: Change of gait performance from pre-test to follow-up
timeFrame: Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
Secondary outcomes:
measure: Change of self-perceived fatigue from pre-test to post-test
timeFrame: Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
measure: Change of self-perceived fatigue from pre-test to follow-up
timeFrame: Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
measure: Change of motor imagery ability from pre-test to post-test
timeFrame: Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
measure: Change of motor imagery ability from pre-test to follow-up
timeFrame: Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
measure: Change of kinesthetic and visual imagery ability from pre-test to post-test
timeFrame: Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
measure: Change of kinesthetic and visual imagery ability from pre-test to follow-up
timeFrame: Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ray-Yau Wang
role: PRINCIPAL_INVESTIGATOR
References: