NCT06841718Enrolling by invitation
Investigating the Neural Signature of Freezing of Gait in Parkinson's Disease
Investigating the Neural Signature of Freezing of Gait Using Ambulatory Electroencephalography in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 24 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 28 (estimated)
- First submitted
- 27 Jan 2025
- Start date
- 4 Nov 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- KU Leuven
- Diseases
- Parkinson disease
- NCT number
- NCT06841718
What you commit to
- Study type: Observational
- Planned participants: 28
- From 4 Nov 2024 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Participation in another clinical intervention study\*
- Unable to adhere to assessment procedures leading to missing or unusable data, as determined by the investigators
- Substance abuse that may interfere with the patient's compliance
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of rehabilitation sciences Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.