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Presence Hallucination in Parkinson's Disease

Primary Purpose

Parkinson Disease Psychosis

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations
Sponsored by
Olaf Blanke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease Psychosis focused on measuring Parkinson, fMRI, connectivity, hallucinations, psychosis, presence hallucination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with Parkinson's disease
  • 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.

Exclusion Criteria:

  • Neurological comorbidities other than Parkinson's disease (e.g. Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, chronic migraine, etc.)
  • 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)
  • The following are due to the MRI scanner: body weight exceeding 160kg, implanted metallic devices, foreign metallic objects, unstable angina, cardio-vascular diseases, tattoos with metallic components, external metallic objects, claustrophobia, pregnancy.

Sites / Locations

  • InselspitalRecruiting
  • Campus Biotech
  • HUGRecruiting
  • Hôpital du ValaisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain changes triggered by PH induction in Parkinson's disease

Arm Description

Clinical and neuropsychological evaluations + Sensorimotor task for PH-induction

Outcomes

Primary Outcome Measures

fMRI bold signal response during robotic manipulation
Analysis of changes of BOLD activity during the asynchronous condition as compared to the synchronous condition
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 assessment of 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

Secondary Outcome Measures

Full Information

First Posted
July 15, 2020
Last Updated
October 1, 2020
Sponsor
Olaf Blanke
Collaborators
University Hospital, Geneva, Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern, Hôpital du Valais
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1. Study Identification

Unique Protocol Identification Number
NCT04579887
Brief Title
Presence Hallucination in Parkinson's Disease
Official Title
Unravelling Dysfunctional Brain Networks in Patients With Parkinson's Disease Suffering From Presence Hallucination
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olaf Blanke
Collaborators
University Hospital, Geneva, Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern, Hôpital du Valais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigation on how robotically mediated sensorimotor stimulation induces and triggers presence hallucinations in patients with Parkinson disease
Detailed Description
Parkinson's Disease (PD) is primarily known and characterized by motor symptoms such as tremor, rigidity and bradykinesia. However, a significant number of non-motor symptoms also accompany the unfolding of this disease. In fact, hallucinations are experienced by approximately 60% of the patients. The most common and amongst one of the earliest hallucinations in Parkinson's Disease, is the Presence Hallucination (PH), i.e., the strange sensation of perceiving someone behind when no one is actually there. In the present study the researchers aim at investigating the behavioural and neural mechanisms underlying symptomatic PH in PD. To do so the researchers intend to induce the PH in a repeated and controlled manner in the MRI scanner, with an extensively verified paradigm which gives rise to this sensation by means of robotically-mediated sensorimotor stimulation. This setup has in fact been shown to trigger the occurrence of symptomatic PH in these patients. The possibility to induce PH while the patient is in the MRI will allow the researchers to investigate online the brain networks associated with it. With analysis on the fine brain connectivity changes during PH-induction, the investigators intend to pinpoint the exact mechanism behind the appearance of this hallucination in these patients, in a similar fashion to previous work with the PH-induction in healthy individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease Psychosis
Keywords
Parkinson, fMRI, connectivity, hallucinations, psychosis, presence hallucination

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain changes triggered by PH induction in Parkinson's disease
Arm Type
Experimental
Arm Description
Clinical and neuropsychological evaluations + Sensorimotor task for PH-induction
Intervention Type
Other
Intervention Name(s)
Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations
Intervention Description
Parkinsonian patients will undergo a two distinct experimental sessions, conducted in two separate days. In day 1, they will complete a series of validated and lab-tailored clinical evaluations, alongside with semi-structured interviews. These tests are designed to assess, the extent of the movement disorder, the predominance of positive symptoms and presence hallucination, potential cognitive impairment, amongst other relevant measures, for sleep assessment, loneliness, apathy and depression. In day 2 patients will perform the described robotic manipulation task in the MRI.
Primary Outcome Measure Information:
Title
fMRI bold signal response during robotic manipulation
Description
Analysis of changes of BOLD activity during the asynchronous condition as compared to the synchronous condition
Time Frame
Approximately 45 minutes during each participant's experimental session in arm 1
Title
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)
Description
Note that for the assessment of 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
Time Frame
Approximately 5 minutes at the end of each participant's experimental session in arm 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Parkinson's disease 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. Exclusion Criteria: Neurological comorbidities other than Parkinson's disease (e.g. Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, chronic migraine, etc.) 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) The following are due to the MRI scanner: body weight exceeding 160kg, implanted metallic devices, foreign metallic objects, unstable angina, cardio-vascular diseases, tattoos with metallic components, external metallic objects, claustrophobia, pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olaf Blanke
Phone
+41 21 693 9621
Email
olaf.blanke@epfl.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Jevita Potheegadoo
Phone
+41 21 693 95 68
Email
jevita.potheegadoo@epfl.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaf Blanke
Organizational Affiliation
Ecole Polytechnique Fédérale de Lausanne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Krack
Phone
+41 21 664 03 71
Email
paul.krack@insel.ch
First Name & Middle Initial & Last Name & Degree
Paul Krack
Facility Name
Campus Biotech
City
Geneva
ZIP/Postal Code
1202
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
HUG
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Burkhard
Phone
+41 22 372 83 18
Email
pierre.burkhard@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Pierre Burkhard
Facility Name
Hôpital du Valais
City
Sion
ZIP/Postal Code
1951
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph-André Ghika
Phone
+41 27 603 40 89
Email
joseph-andre.ghika@hopitalvs.ch
First Name & Middle Initial & Last Name & Degree
Joseph-André Ghika

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25904081
Citation
Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
Results Reference
background
PubMed Identifier
27786242
Citation
Postuma RB, Berg D. Advances in markers of prodromal Parkinson disease. Nat Rev Neurol. 2016 Oct 27;12(11):622-634. doi: 10.1038/nrneurol.2016.152.
Results Reference
background
PubMed Identifier
26733937
Citation
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.
Results Reference
background
PubMed Identifier
19498436
Citation
Diederich NJ, Fenelon G, Stebbins G, Goetz CG. Hallucinations in Parkinson disease. Nat Rev Neurol. 2009 Jun;5(6):331-42. doi: 10.1038/nrneurol.2009.62.
Results Reference
background
PubMed Identifier
21551471
Citation
Fenelon G, Soulas T, Cleret de Langavant L, Trinkler I, Bachoud-Levi AC. Feeling of presence in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2011 Nov;82(11):1219-24. doi: 10.1136/jnnp.2010.234799. Epub 2011 May 7.
Results Reference
background
PubMed Identifier
25447995
Citation
Blanke O, Pozeg P, Hara M, Heydrich L, Serino A, Yamamoto A, Higuchi T, Salomon R, Seeck M, Landis T, Arzy S, Herbelin B, Bleuler H, Rognini G. Neurological and robot-controlled induction of an apparition. Curr Biol. 2014 Nov 17;24(22):2681-6. doi: 10.1016/j.cub.2014.09.049. Epub 2014 Nov 6.
Results Reference
background
Links:
URL
https://www.biorxiv.org/content/10.1101/2020.05.11.054619v1
Description
Bernasconi F, Blondiaux E, Potheegadoo J, Stripeikyte G, ..., Blanke O (2020) sensorimotor hallucinations in Parkinson's disease

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Presence Hallucination in Parkinson's Disease

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