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

National Yang Ming Chiao Tung University

Status: Enrolling

Conditions: Parkinson Disease; Movement Disorder, Functional

Treatments: Other: fNIRS-based neurofeedback with motor imagery; Other: Kinesthetic motor imagery; Other: Motor training

Study type: Interventional

Funder types: Other

Identifiers

NCT05800470

NYCU112020AE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

93 participants in 3 patient groups

Neurofeedback combined with MI (NFB-MI)

Experimental group

Description:

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.

Treatment:

Other: Motor training

Other: fNIRS-based neurofeedback with motor imagery

Motor imagery

Active Comparator group

Description:

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.

Treatment:

Other: Motor training

Other: Kinesthetic motor imagery

Motor training

Active Comparator group

Description:

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.

Treatment:

Other: Motor training