Investigating the Neural Signature of Freezing of Gait in Parkinson's Disease (NCT06841718) | Clinical Trial Compass
By InvitationNot Applicable
Investigating the Neural Signature of Freezing of Gait in Parkinson's Disease
Belgium28 participantsStarted 2024-11-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.\*
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Power spectral density (Watts/hertz) of beta frequencies
Timeframe: During walking protocol (duration 15-20 minutes)
. 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:
. Substance abuse that may interfere with the patient's compliance