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

NCT ID: NCT06841718

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2026-09-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Home assessment

All 28 participants will undergo a single home based assessment including a gait protocol as well as administering clinimetrics and questionnaires. Patients will be tested early in the morning after at least 12 hours without the anti-parkinsonian medication (= 'partial' OFF medication) and then about 1 hour after the intake of the first morning medication dose, when the subject reports reaching self-reported ON state (= ON medication). The gait protocol consist out of A) a trajectory in the participants home from the living room towards the bathroom and back, including a 360° turn as well as a figure-8 turn and going through a doorway and B) a daily living task. All tests will be conducted in a fixed order. The protocol will be conducted as a single task, with a dual task (serial subtraction task), with voluntary stops during different parts of the trajectory, and with an auditory cue (rhythm set 10% slower then typical cadence).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Moran Gilat

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moran Gilat, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

Department of rehabilitation sciences

Leuven, , Belgium

Countries

Belgium

Other Identifiers

s69013

Identifier Type: -

Identifier Source: org_study_id