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

NCT05800470 | Recruiting

• 1 other identifier: NYCU112020AE
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Movement Disorder, Functional

Keywords

Neurofeedback; Motor imagery; Parkinson's disease

Outcome Measures

Primary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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, post-test (4 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 and 4-week follow-up assessment (8 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 and post-test (4 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 and 4-week follow-up assessment (8 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 and post-test (4 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 and 4-week follow-up assessment (8 weeks)

Secondary Outcomes (6)

• Change of self-perceived fatigue from pre-test to mid-test

  Part 2 pre-test and mid-test (2 weeks)

• Change of self-perceived fatigue from pre-test to post-test

  Part 2 pre-test and post-test (4 weeks)

• Change of motor imagery ability from pre-test to mid-test

  Part 2 pre-test and mid-test (2 weeks)

• Change of motor imagery ability from pre-test to post-test

  Part 2 pre-test and post-test (4 weeks)

• Change of kinesthetic and visual imagery ability from pre-test to mid-test

  Part 2 pre-test and mid-test (2 weeks)

Study Arms (3)

Neurofeedback combined with MI (NFB-MI)

EXPERIMENTAL

Participants in both NFB-MI and MI groups will receive a total of 12 sessions of training in 4 weeks. NFB-MI group will receive fNIRS-based neurofeedback during MI training in lab. Prior to each NFB-MI session, 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. Each MI training session (consisting of 5 trials for balance and walking tasks) includes 45 seconds of imagery tasks followed by 15 seconds of rest, repeated twice. The training will take approximately 20 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; Other: Motor training

Motor imagery

ACTIVE COMPARATOR

Participants in both NFB-MI and MI groups will receive a total of 12 sessions of training in 4 weeks. MI group will practice kinesthetic MI under supervision in lab setting. Participants will watch a video of a person executing balance tasks and walking in different environments before MI training. The explicit instruction will be given by the researcher. Each MI training session (consisting of 5 trials for balance and walking tasks) includes 45 seconds of imagery tasks followed by 15 seconds of rest, repeated twice. The training will take approximately 20 minutes. In each training session, actual balance and gait tasks will be practiced for 20 min after MI training. 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.

Other: Kinesthetic motor imagery; Other: Motor training

Motor training

ACTIVE COMPARATOR

The tasks for balance and gait training are similar to those during the MI training. The balance and gait training will be practiced for 20 min in MI and NFB-MI groups, and will be practiced for 40 min in MT group. The difficulty of the tasks will be modified individually for each participant. The researcher will ensure the safety.

Other: Motor training

Interventions

fNIRS-based neurofeedback with motor imagery OTHER

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.

Neurofeedback combined with MI (NFB-MI)

Kinesthetic motor imagery OTHER

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.

Motor imagery

Motor training OTHER

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.

Motor imagery; Motor training; Neurofeedback combined with MI (NFB-MI)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, None Selected, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Conversion Disorder

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Somatoform Disorders; Mental Disorders

Study Officials

• Ray-Yau Wang

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ray-Yau Wang

CONTACT

+88628267210; rywang@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will be blinded to the allocation until the last assessment (4-week follow-up).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 and MT group in people with PD.

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: April 5, 2023
• Study Start: March 19, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

TW (1)