NCT07427498

Brief Summary

The goal of this observational study is to better understand the mechanisms of hallucinations in patients with Parkinson's disease. The main question it aims to answer is: Do prior expectations increase the rate of false perceptions during a visual stimulus detection task more in Parkinson's disease patients with visual hallucinations compared to those without? Participants will undertake a computer task involving face detection and a battery of neuropsychological tests.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
30mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Nov 2028

First Submitted

Initial submission to the registry

February 12, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.6 years

First QC Date

February 12, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

Parkinsonhallucinationneuropsychiatryprior

Outcome Measures

Primary Outcomes (1)

  • Effect of Prior Expectations on False Alarm Rates in Parkinson's Disease Patients With and Without Visual Hallucinations

    The primary outcome measures the false alarm rate during a visual stimulus detection task, specifically the percentage of trials in which participants report perceiving a stimulus when none was presented. The study will assess whether prior expectations (cues indicating the likelihood of a stimulus) increase false alarm rates more in Parkinson's disease patients with visual hallucinations compared to those without. The primary statistical analysis will test for an interaction effect (p \< 0.05) between cue (prior expectation), stimulus presence, and group (patients with vs. without hallucinations) using a generalized linear mixed model.

    Baseline

Secondary Outcomes (4)

  • Comparison of False Alarm Rates Between Parkinson's Patients Without Hallucinations and Healthy Volunteers

    Baseline

  • Impact of Prior Expectations on Perceptual Confidence in Parkinson's Disease Patients With and Without Visual Hallucinations

    Baseline

  • Neuropsychological Profile Differences Between Parkinson's Patients With and Without Hallucinations

    Baseline

  • Beta Power Differences in the Subthalamic Nucleus During False Alarms in Parkinson's Patients With Deep Brain Stimulation

    Baseline

Study Arms (3)

Hallucinations

Patients with Parkinson's disease with hallucinations

No hallucinations

Patients with Parkinson's disease without hallucinations

Control group

Age and sex matched group of healthy participants

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will recruit Parkinson's disease patients (disease duration ≥1 year, no major cognitive impairment) from CHU Grenoble-Alpes, including 15 with minor hallucinations (e.g., passage/presence sensations) and 15 with major hallucinations (e.g., complex visual hallucinations). Patients with active psychosis are excluded. Healthy volunteers (matched by age, gender, and education) will be recruited via ads in senior associations and affiliated institutions (CHUGA, GIN). Matching tolerates ±5 years for age and ±2 years for education; those without a high school diploma will be matched without strict education criteria. Ads may also appear on institutional websites.

You may qualify if:

  • Adults diagnosed with Parkinson's disease (with or without visual hallucinations) or healthy volunteers.
  • Age 18 - 85 years.
  • Consent to participate.

You may not qualify if:

  • Currently participating in another clinical or therapeutic trial involving the testing of a drug treatment.
  • Inability to perform cognitive tests due to:
  • Non-psychiatric (somatic) conditions likely to affect cognitive abilities. Peripheral sensory or motor deficits. Acute clinical conditions (e.g., agitation, impaired consciousness).
  • Diagnosis of dementia.
  • Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code (Code de la Santé Publique), including:
  • Pregnant women, women in labor, or breastfeeding mothers. Individuals deprived of liberty by judicial or administrative decision. Individuals receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 (excluding those covered by Article L. 1121-8).
  • Individuals admitted to a healthcare or social institution for purposes other than research.
  • Minors or adults under legal guardianship or unable to express consent.
  • \- Individuals with a hierarchical relationship to any professional involved in the study.
  • Only for healthy volunteers:
  • \- Personal history of diagnosed neurological disorders.
  • \- Participants included in the study but found to have a MoCA score below 24 will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospitals

La Tronche, France

Location

MeSH Terms

Conditions

Parkinson DiseaseHallucinations

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Castrioto

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Castrioto, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations