Investigating neuromodulation techniques for improving gait in Parkinson's disease
Exploring the Possible Beneficial Impact of Non-invasive and Invasive Neuromodulation on Freezing of Gait in Parkinson's Disease During Different Ambulatory Complexities: An Electrophysiological and fMRI Study
This study is testing different brain stimulation techniques to see if they can help people with Parkinson's disease improve their walking and reduce episodes of freezing while they walk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT06505460 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effects of both non-invasive and invasive neuromodulation techniques on freezing of gait (FOG) in patients with Parkinson's disease. It will utilize an artificial intelligence algorithm to identify and quantify FOG episodes through video and pressure data during walking tasks. Additionally, the study will investigate the underlying neural mechanisms of FOG using advanced electrophysiological methods and fMRI. Finally, it will assess the impact of interventions such as transcranial direct current stimulation and deep brain stimulation on gait performance in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 to 90 diagnosed with Parkinson's disease who experience freezing of gait and have not achieved satisfactory control with medication.
Not a fit: Patients with advanced Parkinson's disease at Hoehn and Yahr Stage 5 or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for managing freezing of gait in Parkinson's disease patients.
How similar studies have performed: While some studies have explored neuromodulation techniques in Parkinson's disease, this specific approach combining AI and various neuromodulation methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients meet the diagnosis of PD based on the established consensus criteria 2. Age above 20 years old and below 90 years 3. For MRgFUS patients: a. At least one of the 3 cardinal symptoms (akinesia, tremor, rigidity) reaches an intensity of at least 2/4. b. Parkinsonian symptoms cannot be satisfactorily controlled by optimal pharmacological treatment including L-dopa and other antiparkinsonian drugs. c. stable medication for PD ≥ 30 days. 4. DBS patients must meet Taiwan Health Insurance criteria: PD duration exceeding 5 years, positive response to levodopa (≥33% UPDRS motor score improvement), and presence of motor complications (e.g., wearing off, on-off, levodopa-related dyskinesia, or medically intractable tremor). Exclusion Criteria: 1. Congestive heart failure (Functional III or above) or advanced cancer with distant metastasis. 2. PD at Hoehn and Yahr Stage 5. 3. DBS exclusion criteria: overt dementia or major depression.
Where this trial is running
Taichung
- China Medical University Hospital/Neuro Depart — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chon-Haw Tsai, PHD
- Email: 008079@tool.caaumed.org.tw
- Phone: 8864-22052121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.