Hallucinations in Parkinson's Disease

NCT04592965 | Unknown

• 1 other identifier: UH_PD
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 6

Brief Summary

Investigation on how robotically mediated sensorimotor stimulation induces and triggers presence hallucinations in different clinical groups of parkinsonian patients, and in aged-matched controls

Conditions

Parkinson Disease Psychosis

Keywords

Parkinson; fMRI; hallucinations; presence hallucination; sense of presence; connectivity

Outcome Measures

Primary Outcomes (4)

• Sensitivity to the induction bodily illusions of Presence Hallucination, Passivity experiences, loss of agency, and control questions, through lab-tailored questionnaires (7-point Likert-scale)

  Note that for the measuring the sensitivity of each patient to the induction of the presence hallucination, passivity sensations, loss of agency, and control questions, the patients will perform two manipulations with the robotic system described in the introduction, in both the synchronous and asynchronous conditions

  5 minutes, at the end of each participant's session in arm 2

• Sensitivity to the induction bodily illusions of Presence Hallucination, Passivity experiences, loss of agency, and control questions, through lab-tailored questionnaires (7-point Likert-scale) in the MRI scanner

  After the sensorimotor task in the MRI scanner that induces the presence hallucination, ratings for the strength of the perceived sense of presence and associated phenomena are collected with the participants

  5 minutes, at the end of each participant's session in arm 4

• fMRI blood-oxygen level dependent signal response during resting state

  We will analyse resting state data from the different populations of PD patients in this study and healthy controls

  Approximately 30 minutes, during arm 3

• fMRI blood-oxygen level dependent signal during robotic stimulation

  We will analyse neural data from PH-induction inside the scanner, from the different populations of PD patients in this study and healthy controls

  Approximately 45 minutes, during arm 4

Secondary Outcomes (16)

• Dosage of dopaminergic medication (in daily equivalent mg/day)

  Approximately 10 minutes during screening

• Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  15 minutes during arm 1

• Scale for the Assessment of Positive Symptoms (SAPS)

  15 minutes during arm 1

• Hallucination questionnaire specific for PD

  15 minutes during arm 1

• The Hospital Anxiety and Depression Scale (HADS)

  5 minutes during arm 1

Study Arms (4)

Clinical and neuropsychological examinations

EXPERIMENTAL

Participants will be assessed by means of validated and lab-tailored clinical scales, alongside with semi-structured interviews, to assess the status of the disease (PD), amongst others, such as cognitive capabilities.

Behavioral: Clinical and neuropsychological assessments

Robot induced PH, through sensorimotor stimulation

EXPERIMENTAL

Participants will manipulate a patented robotic system designed to induce the PH and other accompanying bodily illusions. At the end, participants will report on various subjective experiences, by answering a structured questionnaire.

Behavioral: Induction of PH and associated bodily states

Resting-state fMRI acquistion

EXPERIMENTAL

We will acquire resting-state data in the MRI scanner for all the participants. Respiration and heart beat rate data will also be acquired.

Other: Resting-state fMRI acquisition

Robot induced PH, through sensorimotor stimulation (MRI)

EXPERIMENTAL

All healthy participants, and all patients who are deemed capable of performing the robotic manipulation task in the MRI scanner, will take part on this arm. Participants will perform a robotic manipulation task, with a patented robotic system, capable of inducing the PH and other accompanying bodily illusions in the MRI scanner. At the end participants will report on the various subjective experiences, by answering a structured questionnaire.

Other: Induction of PH and associated bodily states (MRI)

Interventions

Clinical and neuropsychological assessments BEHAVIORAL

The assessment of disease state, clinical condition, and of cognitive and neuropsychological attributes.

Clinical and neuropsychological examinations

Induction of PH and associated bodily states BEHAVIORAL

Assessment of subjective sensitivity to the induction of the PH and associated bodily states, for different populations of PD patients and healthy aged-matched controls

Robot induced PH, through sensorimotor stimulation

Resting-state fMRI acquisition OTHER

Investigation of neural mechanisms at rest, that are potentially disrupted at different degrees, for the different clinical groups of PD patients, compared to the healthy aged-matched controls

Resting-state fMRI acquistion

Induction of PH and associated bodily states (MRI) OTHER

Assessment of subjective sensitivity to the induction of the PH and associated bodily states, for different populations of PD patients and healthy aged-matched controls Assessment and comparison of the neural mechanisms responsible for the induction of the PH and associated bodily illusions, in different groups of PD patients and healthy aged-matched controls

Robot induced PH, through sensorimotor stimulation (MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Parkinson's disease (expect for healthy controls)
• Able to understand instructions and provide informed consent.
• Native speaking language of experimental site (or acquisition of language of experimental site before 6 years old).
• Montreal Cognitive Assessment (Nasreddine \& Patel, 2016) with score ≥ 22.
• Able to manipulate the robotic device.

You may not qualify if:

• For PD patients only: Neurological comorbidities other than Parkinson's disease (e.g. Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, chronic migraine, etc.)
• For healthy controls only: Parkinson's disease or other neurological illnesses
• History or current condition of substance abuse and/or dependence (e.g., alcohol, drugs).
• Suffering from or diagnosed with psychiatric illnesses according to DSM-V criteria (e.g., schizophrenia, bipolar disorders, autism, personality disorders, phobia etc.).
• Family history (1st and 2nd degree) of psychiatric disorders (e.g., schizophrenia or bipolar disorders).
• Severe somatic illnesses (e.g., cancer).
• Severe tremors or physical disability preventing optimal use of robotic device.
• Participating in a pharmacological study.
• Local or general anaesthesia 30 days prior experiment
• Inability to provide informed consent (legal guardianship)
• For the MRI part only: body weight exceeding 160kg, implanted metallic devices, implant for deep brain stimulation, foreign metallic objects, unstable angina, cardio-vascular diseases, tattoos with metallic components, external metallic objects, claustrophobia, pregnancy.

Sponsors & Collaborators

• Olaf Blanke: lead
• University Hospital, Geneva: collaborator
• Hôpital du Valais: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• Hospital de Sant Pau: collaborator

Study Sites (6)

Hospital de la Santa Creu I Sant Pau

Barcelona, 08041, Spain

NOT YET RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

NOT YET RECRUITING

Inselspital

Bern, 1310, Switzerland

RECRUITING

Campus Biotech

Geneva, 1202, Switzerland

ACTIVE NOT RECRUITING

Geneva University Hospital

Geneva, 1202, Switzerland

RECRUITING

Hôpital du Valais

Sion, 1951, Switzerland

RECRUITING

Related Publications (23)

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• Wood RA, Hopkins SA, Moodley KK, Chan D. Fifty Percent Prevalence of Extracampine Hallucinations in Parkinson's Disease Patients. Front Neurol. 2015 Dec 21;6:263. doi: 10.3389/fneur.2015.00263. eCollection 2015.

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Related Links

• Bernasconi F, Blondiaux E, Potheegadoo J, Stripeikyte G, ..., Blanke O. (2020) Sensorimotor hallucinations in Parkinson's Disease

MeSH Terms

Conditions

Hallucinations

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Olaf Blanke

  Ecole Polytechnique Fédérale de Lausanne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olaf Blanke

CONTACT

+41 21 693 9621; olaf.blanke@epfl.ch

Jevita Potheegadoo

CONTACT

+41 21 693 95 68; jevita.potheegadoo@epfl.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: October 19, 2020
• Study Start: August 17, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); CH (5)