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Parkinson Disease PsychosisNCT04579887

Presence Hallucination in Parkinson's Disease

A study testing Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations in people with Parkinson Disease Psychosis, run by Olaf Blanke at 4 sites in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Investigation on how robotically mediated sensorimotor stimulation induces and triggers presence hallucinations in patients with Parkinson disease Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease Psychosis
What is being tested?
Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesSwitzerland
Study dates
17 Aug 2020to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Olaf Blanke contact

+41 21 693 9621

olaf.blanke@epfl.ch

Jevita Potheegadoo contact

+41 21 693 95 68

jevita.potheegadoo@epfl.ch

Switzerland4 sites, 3 recruiting

  • Inselspital

    Bern, 3010

    Paul Krack, +41 21 664 03 71, paul.krack@insel.ch

    Paul Krack

    Recruiting

  • Campus Biotech

    Geneva, 1202

    Active, not recruiting

  • HUG

    Geneva, 1205

    Pierre Burkhard, +41 22 372 83 18, pierre.burkhard@hcuge.ch

    Pierre Burkhard

    Recruiting

  • Hôpital du Valais

    Sion, 1951

    Joseph-André Ghika, +41 27 603 40 89, joseph-andre.ghika@hopitalvs.ch

    Joseph-André Ghika

    Recruiting

Other trials in Switzerland

About this study

Official title: Unravelling Dysfunctional Brain Networks in Patients With Parkinson's Disease Suffering From Presence Hallucination

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

Read the 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.

Being tested
Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations
Keywords
Parkinson, fMRI, connectivity, hallucinations, psychosis, presence hallucination
Medical subject headings
Hallucinations, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04579887
Study groupRoleWhat they receive
Brain changes triggered by PH induction in Parkinson's diseaseExperimentalClinical and neuropsychological evaluations + Sensorimotor task for PH-induction
Receives: Other: Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fMRI bold signal response during robotic manipulation

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

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

  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)

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start17 Aug 2020
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04579887
Sponsor's protocol ID
PD_PH
Status last verified
Oct 2020
First submitted
15 Jul 2020
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25904081

  • 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.

    PubMed 27786242

  • 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.

    PubMed 26733937

  • 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.

    PubMed 19498436

  • 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.

    PubMed 21551471

  • 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.

    PubMed 25447995

Questions about this trial

What is this clinical trial studying?

A study testing Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations in people with Parkinson Disease Psychosis, run by Olaf Blanke at 4 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Olaf Blanke (+41 21 693 9621, olaf.blanke@epfl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fMRI bold signal response during robotic manipulation (time frame: Approximately 45 minutes during each participant's experimental session in arm 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04579887, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

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