NCT04579887

Brief Summary

Investigation on how robotically mediated sensorimotor stimulation induces and triggers presence hallucinations in patients with Parkinson disease

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

July 15, 2020

Last Update Submit

October 1, 2020

Conditions

Parkinson Disease Psychosis

Keywords

ParkinsonfMRIconnectivityhallucinationspsychosispresence hallucination

Outcome Measures

Primary Outcomes (2)

  • fMRI bold signal response during robotic manipulation

    Analysis of changes of BOLD activity during the asynchronous condition as compared to the synchronous condition

    Approximately 45 minutes during each participant's experimental session in arm 1

  • 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

    Approximately 5 minutes at the end of each participant's experimental session in arm 1

Study Arms (1)

Brain changes triggered by PH induction in Parkinson's disease

EXPERIMENTAL

Clinical and neuropsychological evaluations + Sensorimotor task for PH-induction

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

Interventions

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

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.

Brain changes triggered by PH induction in Parkinson's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Inselspital

Bern, 3010, Switzerland

RECRUITING

Campus Biotech

Geneva, 1202, Switzerland

ACTIVE NOT RECRUITING

HUG

Geneva, 1205, Switzerland

RECRUITING

Hôpital du Valais

Sion, 1951, Switzerland

RECRUITING

Related Publications (6)

  • 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.

    PMID: 25904081BACKGROUND

  • 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.

    PMID: 27786242BACKGROUND

  • 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.

    PMID: 26733937BACKGROUND

  • 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.

    PMID: 19498436BACKGROUND

  • 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.

    PMID: 21551471BACKGROUND

  • 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.

    PMID: 25447995BACKGROUND

Related Links

MeSH Terms

Conditions

HallucinationsPsychotic Disorders

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Olaf Blanke

    Ecole Polytechnique Fédérale de Lausanne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olaf Blanke

CONTACT

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

Jevita Potheegadoo

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

July 15, 2020

First Posted

October 8, 2020

Study Start

August 17, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(4)