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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05800470
• Other study ID #: NYCU112020AE
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: National Yang Ming Chiao Tung University
• Contact: Ray-Yau Wang
• Phone: +88628267210
• Email: rywang[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conversion Disorder
• Movement Disorders
• Parkinson Disease

Intervention

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.
• Kinesthetic motor imagery
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming Chiao Tung University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-perceived fatigue for general fatigue level	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 of the study)
Primary	Motor imagery ability	The walking tasks during motor imagery: walkways of 5 m in length, 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 2 sessions in the following sequence: IW- walkway (35cm), and AW- walkway. Each session contains three repeated trials of walking over 5 m 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 of the study and day 8 for second assessment)
Primary	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 of the study and day 8 for second assessment)
Primary	Self-perceived fatigue for concurrent fatigue level	Chinese version of the Brunel Mood Scale (BRUMS-C) will be used to measure subjective perception of fatigue. Fatigue is a subscale of BRUMS-C consisted with 4-item. Participants indicated whether they have felt on a five-point Likert scale (0 = not at all,1 = a little, 2 = moderately, 3 = quite a bit, 4 = extremely) using the "How do you feel right now?" response timeframe. The total score obtained simply by adding 4-item scores together (i.e., 0-16), with higher scores indicating more fatigue.	Part 1 cross-sectional assessment (day 8 of the study)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)