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 range18 Years
SexALL
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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\*
✕
What they're measuring
1
Power spectral density (Watts/hertz) of beta frequencies
Timeframe: During walking protocol (duration 15-20 minutes)
. 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