Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease

Last updated: March 2, 2024
Sponsor: University Hospital, Geneva
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)states

Clinical Study ID

NCT06301282
2021-02341
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. To date, the interplay between cortical activity linked to motor and non-motor symptoms and Parkinson's disease fluctuations linked to dopaminergic medication remain poorly understood.

The aim of the study is to characterize the cortical electroencephalographic oscillatory correlates of Parkinson's disease motor and non-motor fluctuations and the temporal dynamics of their dopaminergic modulation.

For this purpose, the investigators will apply an innovative approach using the differential non-linear temporal dynamics of motor and non-motor state during the transition from the dopaminergic withdrawal phase (i.e. OFF-levodopa state) to the dopaminergic effect phase (i.e. ON-levodopa state) following an acute levodopa administration.

This research will allow to precisely disentangle the network dynamics subtending motor and non-motor symptoms of Parkinson's disease as well as precisely identify the electroencephalographic spectral modulations explaining the neuropsychiatric effects of levodopa. The identification of such biomarkers could pave the way toward innovative therapeutic approaches such as neurofeedback and transmagnetic stimulation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Parkinson's disease (PD) based on United Kingdom PD Society Brain BankCriteria
  • Patients in the PD phase called "fluctuation stage". PD can be defined according tothe four following disease stages: de novo stage (i.e. at the time of diagnosis,dopamine replacement therapy not yet introduced), honeymoon stage (i.e. dopaminereplacement therapy compensates PD symptoms), motor and non-motor fluctuations stage (fluctuations in the clinical effect of the dopamine replacement therapy) and thedecline phase (i.e. onset of cognitive impairment and falls).
  • Presence of motor and non-motor fluctuations are based on:
  • For motor fluctuations: a score of 1 on item 4.1 and/or 1 on item 4.3 of theMovement Disorder Society Unified Parkinson's Disease Rating Scale IV
  • For non-motor fluctuations: a score of 2 on item III of the Behavioral Assessmentof PD
  • To be on dopaminergic replacement therapy. The daily dose of dopaminergic replacementtherapy will be converted into a common unit (levodopa equivalent daily dose) to getan idea of the dopaminergic replacement therapy dose needed per day for each patient The course of PD, and in particular the time of each PD phase, is very variable from onepatient to another. A precise duration of illness can therefore not be included in theinclusion criteria. The dose of dopaminergic replacement therapy required for each patientis also extremely variable from one patient to another and cannot be included in theinclusion criteria. Healthy controls will be subjects:

• Without any known central nervous system (CNS) lesion or CNS clinical signs onexamination

Exclusion

Exclusion Criteria:

  • Age greater than 80 years
  • Dementia or mild cognitive impairment based on a score <24 on the MOntreal CognitiveAssessment,
  • Ongoing depression with suicidal ideation,
  • Any clinically meaningful non-stable renal, hepatic, cardiovascular, respiratory,cerebrovascular disease or other serious progressive physical diseases,
  • Participating in a pharmacological study,
  • Intolerable "OFF-levodopa" states when the effects of the PD medication wear off (e.g., severe pain, anxiety, depression at the end of the dose or in the morning uponwaking),
  • Inability to provide informed consent (legal guardianship),
  • Inability to speak or read French.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)states
Phase:
Study Start date:
March 03, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • University Hospital, Geneva

    Geneva, 1204
    Switzerland

    Active - Recruiting

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