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

NCT06841718 | Enrolling By Invitation

• 1 other identifier: s69013
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

Parkinson's Disease; electroencephalography (EEG); freezing of gait; gait problems

Outcome Measures

Primary Outcomes (1)

• Power spectral density (Watts/hertz) of beta frequencies

  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.

  During walking protocol (duration 15-20 minutes)

Secondary Outcomes (3)

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

  During walking protocol (duration 15-20 minutes)

• Cross-frequency coupling between beta and theta frequency bands

  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.

  During walking protocol (duration 15-20 minutes)

Other Outcomes (4)

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

  During walking protocol (duration 15-20 minutes)

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

  During walking protocol (duration 15-20 minutes)

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

  During walking protocol (duration 15-20 minutes)

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with Parkinson's Disease who self-report to experience FOG more than once a day.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Department of rehabilitation sciences

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Parkinson Disease; Basal Ganglia Diseases; Brain Diseases; Movement Disorders; Neurodegenerative Diseases; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Moran Gilat, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 24, 2025
• Study Start: November 4, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

BE (1)