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Enrolling by invitation NCT06841718

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

— Observational Parkinson Disease Freezing of Gait Basal Ganglia Diseases Brain Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinson Disease, Freezing of Gait, Basal Ganglia Diseases, Brain Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • Power spectral density (Watts/hertz) of beta frequencies [Time frame: During walking protocol (duration 15-20 minutes)]
Secondary outcome measures (3)
  • Power spectral density (Watts/hertz) of theta frequencies bands [Time frame: During walking protocol (duration 15-20 minutes)]
  • Cross-frequency coupling between beta and theta frequency bands [Time frame: During walking protocol (duration 15-20 minutes)]
  • Power spectral density (Watts/hertz) and cross-frequency coupling (CFC) of beta and theta frequencies bands over other cortical areas. [Time frame: During walking protocol (duration 15-20 minutes)]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of Parkinson's disease (PD) made by a Neurologist\*
  • Modified Hoehn \& Yahr (H\&Y) Stage I to IV in the ON medication state
  • Age above 18 years\*
  • Able to walk 5 minutes while unassisted by a walker or another person (the use of a cane is allowed).\*
  • Mini Mental State Examination>= 21
  • At least three hours in-between regular medication intakes to allow for stable testing time.\*
  • 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.\*
  • Stable medication scheme for at least 7 days before enrollment.

Exclusion criteria

  • Participation in another clinical intervention study\*
  • 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
  • Unable to adhere to assessment procedures leading to missing or unusable data, as determined by the investigators
  • Not a stable medication scheme for at least 7 days before the assessment.\*
  • 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
  • Substance abuse that may interfere with the patient's compliance

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Department of rehabilitation sciences — Leuven

Identifiers

NCT: NCT06841718 · s69013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗