Psychological Effects of Levodopa in Parkinson's Disease

NCT05119075 | Completed

• 1 other identifier: 2021-01608
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief Summary

The investigators aim is to study neuropsychiatric symptoms and underlying abnormalities in resting-state fMRI in patients with Parkinson's disease (PD) suffering from neuropsychiatric fluctuations, to enhance the understanding of the pathophysiological mechanisms underlying neuropsychiatric symptoms.

Conditions

Parkinson Disease

Keywords

Neuropsychiatric fluctuations; Creativity; Shame; Embarrassment; Non-motor symptoms; Hallucinations; Bradyphrenia

Outcome Measures

Primary Outcomes (5)

• Correlation of functional connectivity abnormalities with neuropsychiatric fluctuations

  Score on the Neuropsychiatric Fluctuations Scale (NFS)

  ≤ 6 weeks

• Correlation of functional connectivity abnormalities with shame

  Score on the Shame Visual Analogic Scale

  ≤ 6 weeks

• Correlation of functional connectivity abnormalities with hallucinations

  Score on robot-induced presence hallucination (PH) ratings

  ≤ 6 weeks

• Correlation of functional connectivity abnormalities with bradyphrenia

  Score on the Bradyphrenia Scale

  ≤ 6 weeks

• Correlation of functional connectivity abnormalities with creativity

  Score on the Creative Thinking Scale

  ≤ 6 weeks

Secondary Outcomes (4)

• The role of dopamine on hallucinations

  ≤ 6 weeks

• The role of dopamine on creativity

  ≤ 6 weeks

• The role of dopamine on shame

  ≤ 6 weeks

• The role of dopamine on bradyphrenia

  ≤ 6 weeks

Study Arms (2)

Dopaminergic ON-drug state first, dopaminergic OFF-drug state second

EXPERIMENTAL

The following examinations and assessments will be performed at visit 3 on regular treatment in dopaminergic ON-drug state and at visit 4 in dopaminergic OFF-drug state (overnight withdrawal of all antiparkinsonian drugs): * MRI assessment, * Cognitive, neuropsychiatric and neurological assessment, * Robot-induced hallucinations through sensorimotor stimulation.

Other: Dopaminergic OFF-drug state; Other: Dopaminergic ON-drug state

Dopaminergic OFF-drug state first, dopaminergic ON-drug state second

EXPERIMENTAL

The following examinations and assessments will be performed at visit 3 in dopaminergic OFF-drug state (overnight withdrawal of all antiparkinsonian drugs) and at visit 4 on regular treatment in dopaminergic ON-drug state: * MRI assessment, * Cognitive, neuropsychiatric and neurological assessment, * Robot-induced hallucinations through sensorimotor stimulation.

Other: Dopaminergic OFF-drug state; Other: Dopaminergic ON-drug state

Interventions

Dopaminergic OFF-drug state OTHER

Dopaminergic OFF-drug state: Overnight withdrawal of dopaminergic antiparkinsonian drugs during visit 3 or 4. The sequence of drug conditions (dopaminergic OFF-drug/ON-drug state or ON-drug/OFF-drug state) will be randomized.

Dopaminergic OFF-drug state first, dopaminergic ON-drug state second; Dopaminergic ON-drug state first, dopaminergic OFF-drug state second

Dopaminergic ON-drug state OTHER

Dopaminergic ON-drug state: Patient will be evaluated in his/her regular treatment in dopaminergic ON-drug state at visit 3 or 4. The sequence of drug conditions (dopaminergic OFF-drug/ON-drug state or ON-drug/OFF-drug state) will be randomized.

Dopaminergic OFF-drug state first, dopaminergic ON-drug state second; Dopaminergic ON-drug state first, dopaminergic OFF-drug state second

Eligibility Criteria

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

You may qualify if:

• Adults above 18 years old
• Male or female
• Diagnosed with Parkinson's disease
• Able to understand instructions, neuropsychological tests and provide written informed consent
• Able to understand the locally used language of the experimental site and speak fluently
• Presence of neuropsychiatric fluctuations, defined as the sum ≥ 3 of items included in the Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD) part 2

You may not qualify if:

• Structural brain disease other than Parkinson's disease
• Substance abuse and/or dependence (other than DRT)
• Ongoing depression with suicidal ideation
• Severe tremors/dyskinesia/ interfering with MRI performance
• Participating in a pharmacological study
• Inability to provide informed consent (legal guardianship)
• MRI contraindications
• Pregnancy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital, Geneva: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (4)

University Hospital Inselspital, Berne

Bern, 3010, Switzerland

Location

EPFL Campus Biotech

Geneva, 1202, Switzerland

Location

EPFL Institute of Bioengineering

Geneva, 1202, Switzerland

Location

University Hospital Geneva (HUG)

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Parkinson Disease; Hallucinations

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Krack, Prof.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 12, 2021
• Study Start: November 10, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)