Presence Hallucination in Parkinson's Disease

NCT ID: NCT04579887

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-17
• Study Completion Date: 2021-06-30

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.

Conditions

Parkinson Disease Psychosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Brain changes triggered by PH induction in Parkinson's disease

Clinical and neuropsychological evaluations + Sensorimotor task for PH-induction

Group Type: EXPERIMENTAL

Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations

Intervention Type: OTHER

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.

Interventions

Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

Hôpital du Valais

OTHER

Sponsor Role: collaborator

Olaf Blanke

OTHER

Sponsor Role: lead

Responsible Party

Olaf Blanke

Professor Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Olaf Blanke

Role: PRINCIPAL_INVESTIGATOR

Ecole Polytechnique Fédérale de Lausanne

Locations

Inselspital

Bern, , Switzerland

Site Status: RECRUITING

Campus Biotech

Geneva, , Switzerland

Site Status: ACTIVE_NOT_RECRUITING

HUG

Geneva, , Switzerland

Site Status: RECRUITING

Hôpital du Valais

Sion, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Olaf Blanke

Role: CONTACT

olaf.blanke@epfl.ch

+41 21 693 9621

Jevita Potheegadoo

Role: CONTACT

jevita.potheegadoo@epfl.ch

+41 21 693 95 68

Facility Contacts

Paul Krack

Role: primary

paul.krack@insel.ch

+41 21 664 03 71

Pierre Burkhard

Role: primary

pierre.burkhard@hcuge.ch

+41 22 372 83 18

Joseph-André Ghika

Role: primary

joseph-andre.ghika@hopitalvs.ch

+41 27 603 40 89

References

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.

Reference Type: BACKGROUND

PMID: 25904081 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27786242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26733937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19498436 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21551471 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25447995 (View on PubMed)

Other Identifiers

PD_PH

Identifier Type: -

Identifier Source: org_study_id