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

Study Overview
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Brief Summary
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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
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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 questionnaire for fatigue, motor imagery ability, and brain activation during walking tasks will be recorded and compared between groups using independent t test. Pearson's correlation coefficient will be used to determine the relationship between fatigue and MI ability. 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.

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

Conditions
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Parkinson Disease, Movement Disorder, Functional

Intervention / Treatment
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* Other: fNIRS-based neurofeedback with motor imagery
* Other: Kinesthetic motor imagery


Participation Criteria
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Eligibility Criteria
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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; 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. obtaining the Handbook of Disabilities verified by the government of local cities in Taiwan. 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. obtaining the Handbook of Disabilities verified by the government of local cities in Taiwan.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback combined with MI (NFB-MI)<br>Participants in both NFB-MI and MI groups will receive a total of 12 sessions of training in 3 weeks. At the first, 4th and 8th session, NFB-MI group will receive fNIRS-based neurofeedback during MI training in lab setting. Prior to each NFB-MI session during lab visit, participants will watch a video of a person executing balance tasks and walking in different environments. The explicit instruction will be given by the researcher. One trial of MI training consists of 30 seconds of imagery tasks and 20 seconds of rest, and the trial will be repeated 12 times. The training will take approximately 10 minutes. Visual feedback with a thermometer based on the changes of HbO concentration will be displayed on the screen during NFB-MI training. In each training session, actual balance and gait tasks will be practiced for 20 min. The difficulty of the tasks will be modified individually for each participant. | Other: fNIRS-based neurofeedback with motor imagery<br>* 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.<br>|
| Active Comparator: Motor imagery<br>Participants in both NFB-MI and MI groups will receive a total of 12 sessions of training in 3 weeks. At the first, 4th and 8th session, MI group will practice kinesthetic MI under supervision in lab setting. Prior to each NFB-MI session during lab visit, participants will watch a video of a person executing balance tasks and walking in different environments. The explicit instruction will be given by the researcher. One trial of MI training consists of 30 seconds of imagery tasks and 20 seconds of rest, and the trial will be repeated 12 times. The training will take approximately 10 minutes. In each training session, actual balance and gait tasks will be practiced for 20 min. The difficulty of the tasks will be modified individually for each participant. The researcher will ensure the safety of executing each task during lab visit. Participants will be asked to practice at home and be checked by the daily phone call. | Other: Kinesthetic motor imagery<br>* Participants will be asked to practice MI with kinesthetic strategy in the first-person perspective for balance and gait tasks in 10 mins. After the MI training, they will receive 20-min balance and gait training, the same as in experimental group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-perceived fatigue | Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) will be used to measure subjective perception of fatigue. MFI-TC is a 20-item self-report scale evaluating different dimensions of fatigue (general fatigue/physical fatigue, reduced activity, reduced motivation and mental fatigue). Each item is scored on a 1 (strongly agree) to 5 (strongly disagree) scale to assess how well the statement describe the participant's experience of fatigue. Ten positively phrased items (item 2, 5, 9, 10, 13, 14, 16, 17, 18, 19) were reverse-scored before adding up scores. The total score obtained simply by adding 20-item scores together (i.e., 20-100), with higher scores indicating more fatigue. | Part 1 cross-sectional assessment (day 1) | 
| Motor imagery ability | There are two conditions for walking tasks during motor imagery: wide and narrow walkways of 15 m in length, and respectively 2 m and 35 cm in width. participants will be asked to stand upright at the starting line, and then perform imagery walking (IW) and actual walking (AW) task in a total of four sessions in the following sequence: IW-wide walkway (2m), AW-wide walkway, IW-narrow walkway (35cm), and AW-narrow walkway. Each session contains three repeated trials of walking over 15 m wide or narrow walkways. The MI ability will be indicated by the index of performance (IP) calculated by [(AW - IW/ AW) * 100]. IP closer to zero indicates better MI ability. | Part 1 cross-sectional assessment (day 1) | 
| Kinesthetic and visual imagery ability | Kinesthetic and visual imagery questionnaire-short version (KVIQ-10) will be used to assess kinesthetic and visual imagery ability. 5 movement will be demonstrated by the assessor and mimicked by the participant. The participant will be asked to visually and kinesthetically imagine the movement without doing the movement. The clarity of the image (visual subscale) and the intensity of the sensations (kinesthetic subscale) will be scored on a five point ordinal scale. The total scores ranged from 10 to 50, and higher scores indicate better ability on kinesthetic and visual imagery. | Part 1 cross-sectional assessment (day 1) | 
| Brain activation | The hemodynamic signals during AW and IW in all the participants will be recorded. A multichannel wearable functional near-infrared spectroscopy (fNIRS) imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) will be used to detect the cortical activity in prefrontal cortex (PFC), premotor cortex (PMC) and supplementary motor areas (SMA). | Part 1 cross-sectional assessment (day 1) | 
| Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to post-test | Mini-BEST is used to measure dynamic balance ability in four domains: anticipatory postural adjustment, reactive postural adjustments, sensory integration and dynamic gait. Mini-BEST consists of 14 items scored on a 0-2 scale, with 2 items assess right and left sides. The total scores will be 0-32, and higher scores indicate better balance ability. The scores at pre-test subtracting from the scores at post-test will be presented. | Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks) | 
| Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to follow-up | Mini-BEST is used to measure dynamic balance ability in four domains: anticipatory postural adjustment, reactive postural adjustments, sensory integration and dynamic gait. Mini-BEST consists of 14 items scored on a 0-2 scale, with 2 items assess right and left sides. The total scores will be 0-32, and higher scores indicate better balance ability.The scores at pre-test subtracting from the scores at follow-up will be presented. | Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks) | 
| Change of Timed up-and-go test (TUG) from pre-test to post-test | Functional mobility will be indicated by TUG. Participants will be asked to stand up from a chair, walk at comfortable speed for 3 m, turn around and sit back on the chair. The completing duration will be measured, and the mean value across 3 trials of TUG will be documented as the final performance. The shorter completing duration indicates better mobility function. The duration at pre-test subtracting from the duration at post-test will be presented. | Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks) | 
| Change of Timed up-and-go test (TUG) from pre-test to follow-up | Functional mobility will be indicated by TUG. Participants will be asked to stand up from a chair, walk at comfortable speed for 3 m, turn around and sit back on the chair. The completing duration will be measured, and the mean value across 3 trials of TUG will be documented as the final performance. The shorter completing duration indicates better mobility function. The duration at pre-test subtracting from the duration at follow-up will be presented. | Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks) | 
| Change of gait performance from pre-test to post-test | The gait parameters will be measured by a GAITRite system (CIR system, Inc., Havertown, Pennsylvania). The GAITRite system is a 4.57 m long, 0.9 m wide straight walkway containing pressure-sensitive sensors in a 3.66 m by 0.61 m area. The participants will be instructed to walk along the walkway at their comfortable speed for 3 times. The values at pre-test subtracting from the values at post-test will be presented. | Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks) | 
| Change of gait performance from pre-test to follow-up | The gait parameters will be measured by a GAITRite system (CIR system, Inc., Havertown, Pennsylvania). The GAITRite system is a 4.57 m long, 0.9 m wide straight walkway containing pressure-sensitive sensors in a 3.66 m by 0.61 m area. The participants will be instructed to walk along the walkway at their comfortable speed for 3 times. The values at pre-test subtracting from the values at follow-up will be presented. | Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of self-perceived fatigue from pre-test to post-test | Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) will be used to measure subjective perception of fatigue. MFI-TC is a 20-item self-report scale evaluating different dimensions of fatigue (general fatigue/physical fatigue, reduced activity, reduced motivation and mental fatigue). Each item is scored on a 1 (strongly agree) to 5 (strongly disagree) scale to assess how well the statement describe the participant's experience of fatigue. Ten positively phrased items (item 2, 5, 9, 10, 13, 14, 16, 17, 18, 19) were reverse-scored before adding up scores. The total score obtained simply by adding 20-item scores together (i.e., 20-100), with higher scores indicating more fatigue. The scores at pre-test subtracting from the scores at post-test will be presented. | Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks) | 
| Change of self-perceived fatigue from pre-test to follow-up | Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) will be used to measure subjective perception of fatigue. MFI-TC is a 20-item self-report scale evaluating different dimensions of fatigue (general fatigue/physical fatigue, reduced activity, reduced motivation and mental fatigue). Each item is scored on a 1 (strongly agree) to 5 (strongly disagree) scale to assess how well the statement describe the participant's experience of fatigue. Ten positively phrased items (item 2, 5, 9, 10, 13, 14, 16, 17, 18, 19) were reverse-scored before adding up scores. The total score obtained simply by adding 20-item scores together (i.e., 20-100), with higher scores indicating more fatigue. The scores at pre-test subtracting from the scores at follow-up will be presented. | Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks) | 
| Change of motor imagery ability from pre-test to post-test | There are two conditions for walking tasks during motor imagery: wide and narrow walkways of 15 m in length, and respectively 2 m and 35 cm in width. participants will be asked to stand upright at the starting line, and then perform imagery walking (IW) and actual walking (AW) task in a total of four sessions in the following sequence: IW-wide walkway (2m), AW-wide walkway, IW-narrow walkway (35cm), and AW-narrow walkway. Each session contains three repeated trials of walking over 15 m wide or narrow walkways. The MI ability will be indicated by the index of performance (IP) calculated by [(AW - IW/ AW) * 100]. IP closer to zero indicates better MI ability. The scores at pre-test subtracting from the scores at post-test will be presented. | Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks) | 
| Change of motor imagery ability from pre-test to follow-up | There are two conditions for walking tasks during motor imagery: wide and narrow walkways of 15 m in length, and respectively 2 m and 35 cm in width. participants will be asked to stand upright at the starting line, and then perform imagery walking (IW) and actual walking (AW) task in a total of four sessions in the following sequence: IW-wide walkway (2m), AW-wide walkway, IW-narrow walkway (35cm), and AW-narrow walkway. Each session contains three repeated trials of walking over 15 m wide or narrow walkways. The MI ability will be indicated by the index of performance (IP) calculated by [(AW - IW/ AW) * 100]. IP closer to zero indicates better MI ability. The scores at pre-test subtracting from the scores at follow-up will be presented. | Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks) | 
| Change of kinesthetic and visual imagery ability from pre-test to post-test | Kinesthetic and visual imagery questionnaire-short version (KVIQ-10) will be used to assess kinesthetic and visual imagery ability. 5 movement will be demonstrated by the assessor and mimicked by the participant. The participant will be asked to visually and kinesthetically imagine the movement without doing the movement. The clarity of the image (visual subscale) and the intensity of the sensations (kinesthetic subscale) will be scored on a five point ordinal scale. The total scores ranged from 10 to 50, and higher scores indicate better ability on kinesthetic and visual imagery. The scores at pre-test subtracting from the scores at post-test will be presented. | Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks) | 
| Change of kinesthetic and visual imagery ability from pre-test to follow-up | Kinesthetic and visual imagery questionnaire-short version (KVIQ-10) will be used to assess kinesthetic and visual imagery ability. 5 movement will be demonstrated by the assessor and mimicked by the participant. The participant will be asked to visually and kinesthetically imagine the movement without doing the movement. The clarity of the image (visual subscale) and the intensity of the sensations (kinesthetic subscale) will be scored on a five point ordinal scale. The total scores ranged from 10 to 50, and higher scores indicate better ability on kinesthetic and visual imagery. The scores at pre-test subtracting from the scores at follow-up will be presented. | Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurofeedback, Motor imagery, Parkinson's disease