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Enrolling by Invitation

NCT Number: NCT06841718

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Disease Brain Diseases Central Nervous System Diseases Freezing of Gait Mobility Limitation Movement Disorders Nervous System Diseases Neurodegenerative Disease Neurodegenerative Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of rehabilitation sciences

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Power spectral density (Watts/hertz) of beta frequencies

    Time frame: 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 outcomes

  1. Power spectral density (Watts/hertz) of theta frequencies bands

    Time frame: 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.

  2. Cross-frequency coupling between beta and theta frequency bands

    Time frame: 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.

  3. 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)

    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.

Other outcomes

  1. Power spectrum density and cross-frequency coupling in ON medication state

    Time frame: During walking protocol (duration 15-20 minutes)

    Comparing the PSD/CFC of the primary and secondary outcomes averaged across all FOG episodes to typical gait performance during optimal ON medication state (1 hour post-medication intake)

  2. Power spectrum density and cross-frequency coupling in OFF medication state

    Time frame: During walking protocol (duration 15-20 minutes)

    Comparing the PSD/CFC of the primary and secondary outcomes averaged across all FOG episodes to typical gait performance during the practically defined OFF medication state (after minimal 12 hours overnight withdrawal).

  3. Comparing the Power spectrum density and cross-frequency coupling in ON and OFF medication state

    Time frame: During walking protocol (duration 15-20 minutes)

    Comparing the PSD/CFC averaged across all FOG episodes compared to typical gait performance between OFF and ON medication states

  4. Comparing the Power spectrum density and cross-frequency coupling between different FOG manifestations

    Time frame: During walking protocol (duration 15-20 minutes)

    Comparing the averaged PSD/CFC between the different FOG manifestations (Akinetic vs. Kinetic FOG trembling vs. Kinetic non-trembling vs. Kinetic-festination) in the ON and OFF medication states.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Acronym: FOG-EEG

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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