Investigating the Neural Signature of Freezing of Gait in Parkinson's Disease

• Conditions: Parkinson Disease; Freezing of Gait; Basal Ganglia Diseases; Brain Disease; Movement Disorders; Neurodegenerative Disease

• Registration Number: NCT06841718
• Lead Sponsor: KU Leuven

Brief Summary

Freezing of Gait (FOG) is a disabling symptom of Parkinson's disease (PD) and a leading cause for falls. Current medical management is inadequate to alleviate FOG so there is need for improved treatments. A major draw-back in the development of better treatments for FOG is the difficulty in detecting episodes and our poor understanding of its underlying pathophysiology.

This study will investigate the cortical signature of FOG using ambulatory electroencephalography (EEG) to help improve FOG detection algorithms and provide novel insights into the underlying pathophysiology, which together will guide therapy development.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-04
• Study First Submitted: 2025-01-27
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Clinical diagnosis of Parkinson's disease (PD) made by a Neurologist*
2. Modified Hoehn & Yahr (H&Y) Stage I to IV in the ON medication state
3. Age above 18 years*
4. Able to walk 5 minutes while unassisted by a walker or another person (the use of a cane is allowed).*
5. Mini Mental State Examination>= 21
6. At least three hours in-between regular medication intakes to allow for stable testing time.*
7. Self-reported FOG with a severity of at least 1 FOG episode per day, based on items 1 and 2 of the New Freezing of Gait Questionnaire, irrespective of FOG occurring ON- or OFF-medication.*
8. Stable medication scheme for at least 7 days before enrollment.

Exclusion Criteria

1. Participation in another clinical intervention study*

2. Acute musculoskeletal or other neurological, psychiatric, or cardiovascular conditions affecting gait or any other medical condition which, in the opinion of the investigator, may prevent the participant from completing the protocol in full

3. Unable to adhere to assessment procedures leading to missing or unusable data, as determined by the investigators

4. Not a stable medication scheme for at least 7 days before the assessment.*

5. Occurrence of any of the following within 3 months prior to informed consent:

   • Orthopedic surgery of the lower extremity
   • Myocardial infarction
   • Hospitalization for unstable angina
   • Coronary artery bypass graft
   • Percutaneous coronary intervention
   • Implantation of a cardiac resynchronization therapy device
   • Implantation of deep brain stimulation

6. Substance abuse that may interfere with the patient's compliance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Power spectral density (Watts/hertz) of beta frequencies	During walking protocol (duration 15-20 minutes)	The averaged power spectral density (PSD) of the beta (12-25 Hz) frequency band measured over the motor cortices during freezing of gait (FOG) episodes compared to typical gait performance in the same individual with Parkinson's disease as measured during different walking trajectories in the home setting.

Secondary Outcome Measures

Name	Time	Method
Power spectral density (Watts/hertz) of theta frequencies bands	During walking protocol (duration 15-20 minutes)	The averaged power spectral density (PSD) of the theta (4-7 Hz) frequency band measured over the prefrontal cortices during freezing of gait (FOG) episodes compared to typical gait performance in the same individual with Parkinson's disease as measured during different walking trajectories in the home setting.
Cross-frequency coupling between beta and theta frequency bands	During walking protocol (duration 15-20 minutes)	The averaged cross-frequency coupling (CFC) between the beta (12-25 Hz) and theta (4-7 Hz) frequency bands as measured over the motor and prefrontal cortices during freezing of gait (FOG) episodes compared to typical gait performance in the same individual with Parkinson's disease as measured during different walking trajectories in the home setting.
Power spectral density (Watts/hertz) and cross-frequency coupling (CFC) of beta and theta frequencies bands over other cortical areas.	During walking protocol (duration 15-20 minutes)	The averaged power spectral density (PSD) of the beta (12-25 Hz) and theta (4-7 Hz) frequency band measured over other cortical areas (prefrontal, motor, temporal, parietal, visual) during freezing of gait (FOG) episodes compared to typical gait performance in the same individual with Parkinson's disease as measured during different walking trajectories in the home setting.

Trial Locations

Locations (1)

Department of rehabilitation sciences; 🇧🇪 Leuven, Belgium