fNIRS neurofeedback with motor imagery to improve balance and walking in Parkinson's disease

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

This will see if adding fNIRS-based neurofeedback to motor imagery can improve balance and walking in people with Parkinson's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: National Yang Ming Chiao Tung University (Academic / other)
• Locations: 1 site (Taipei, None Selected)
• Trial ID: NCT05800470 on ClinicalTrials.gov

What this trial studies

The study has two parts: a cross-sectional comparison of motor imagery ability and the effects of fatigue in people with Parkinson's disease versus age-matched healthy controls, and a randomized controlled trial testing interventions in people with Parkinson's. In the RCT, participants are randomly assigned to neurofeedback-plus-motor-imagery, motor-imagery-only, or motor training groups and receive 12 sessions over four weeks. Neurofeedback uses functional near-infrared spectroscopy (fNIRS) during 20-minute motor imagery sessions, followed by balance and gait training, while outcomes (Mini-BEST, TUG, gait measures) are measured before, after, and at follow-up. The cross-sectional part examines general and induced fatigue using validated scales and correlates fatigue levels with motor imagery ability.

Who should consider this trial

Good fit: Ideal candidates are people aged 40–85 with idiopathic Parkinson's disease (Hoehn and Yahr stage <4), stable medical treatment, able to walk independently for at least 10 minutes, and without major cognitive impairment or very low motor imagery ability.

Not a fit: Patients unlikely to benefit include those with significant cognitive impairment (MMSE <24), very low motor imagery ability (KVIQ <25), deep brain stimulation or brain metal implants, other neurological or psychiatric disorders, or who cannot attend in-person sessions.

Why it matters

Potential benefit: If successful, this approach could improve balance and gait and potentially reduce fall risk in people with Parkinson's disease.

How similar studies have performed: Related neurofeedback and motor imagery studies in Parkinson's have shown promising but preliminary results in small samples, so fNIRS-based neurofeedback for gait and balance remains relatively novel.

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.

Where this trial is running

Taipei, None Selected

• National Yang Ming Chiao Tung University — Taipei, None Selected, Taiwan (Recruiting)

Study contacts

• Principal investigator: Ray-Yau Wang — National Yang Ming Chiao Tung University
• Study coordinator: Ray-Yau Wang

Conditions Parkinson Disease; Movement Disorder, Functional; Neurofeedback; Motor imagery; Parkinson's disease