Clinical trial NCT06841718: Investigating the Neural Signature of Freezing of Gait in Parkinson's Disease
Official title: Investigating the Neural Signature of Freezing of Gait Using Ambulatory Electroencephalography in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Parkinson Disease
Freezing of Gait
Basal Ganglia Diseases
Brain Disease
Movement Disorders
Neurodegenerative Disease
Keywords: Parkinson&#39;s Disease
electroencephalography (EEG)
freezing of gait
gait problems
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Parkinson's Disease who self-report to experience FOG more than once a day.

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.


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

Primary outcomes:
measure: Power spectral density (Watts/hertz) of beta frequencies
timeFrame: During walking protocol (duration 15-20 minutes)
Secondary outcomes:
measure: Power spectral density (Watts/hertz) of theta frequencies bands
timeFrame: During walking protocol (duration 15-20 minutes)
measure: Cross-frequency coupling between beta and theta frequency bands
timeFrame: During walking protocol (duration 15-20 minutes)
measure: Power spectral density (Watts/hertz) and cross-frequency coupling (CFC) of beta and theta frequencies bands over other cortical areas.
timeFrame: During walking protocol (duration 15-20 minutes)
Other outcomes:
measure: Power spectrum density and cross-frequency coupling in ON medication state
timeFrame: During walking protocol (duration 15-20 minutes)
measure: Power spectrum density and cross-frequency coupling in OFF medication state
timeFrame: During walking protocol (duration 15-20 minutes)
measure: Comparing the Power spectrum density and cross-frequency coupling in ON and OFF medication state
timeFrame: During walking protocol (duration 15-20 minutes)
measure: Comparing the Power spectrum density and cross-frequency coupling between different FOG manifestations
timeFrame: During walking protocol (duration 15-20 minutes)
Locations:
city: Leuven
country: Belgium
facility: Department of rehabilitation sciences
Study officials:
affiliation: KU Leuven
name: Moran Gilat, PhD
role: PRINCIPAL_INVESTIGATOR
References: