Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-08-17
2021-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Presence Hallucination in Parkinson's Disease
NCT04579887
Role of Retina in Mechanisms of Illusions and Visual Hallucinations Observed in Idiopathic Parkinson's Disease
NCT03454269
Psychological Effects of Levodopa in Parkinson's Disease
NCT05119075
Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease
NCT03105401
Psychiatric and Cognitive Manifestations of Parkinson's Disease
NCT00360633
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clinical and neuropsychological examinations
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.
Clinical and neuropsychological assessments
The assessment of disease state, clinical condition, and of cognitive and neuropsychological attributes.
Robot induced PH, through sensorimotor stimulation
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.
Induction of PH and associated bodily states
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
Resting-state fMRI acquistion
We will acquire resting-state data in the MRI scanner for all the participants. Respiration and heart beat rate data will also be acquired.
Resting-state fMRI acquisition
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
Robot induced PH, through sensorimotor stimulation (MRI)
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.
Induction of PH and associated bodily states (MRI)
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical and neuropsychological assessments
The assessment of disease state, clinical condition, and of cognitive and neuropsychological attributes.
Induction of PH and associated bodily states
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
Resting-state fMRI acquisition
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
Induction of PH and associated bodily states (MRI)
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Geneva
OTHER
Hôpital du Valais
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
Hospital de Sant Pau
OTHER
Olaf Blanke
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Olaf Blanke
Professor Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Olaf Blanke
Role: PRINCIPAL_INVESTIGATOR
Ecole Polytechnique Fédérale de Lausanne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
Inselspital
Bern, , Switzerland
Campus Biotech
Geneva, , Switzerland
Geneva University Hospital
Geneva, , Switzerland
Hôpital du Valais
Sion, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Ffytche DH, Aarsland D. Psychosis in Parkinson's Disease. Int Rev Neurobiol. 2017;133:585-622. doi: 10.1016/bs.irn.2017.04.005. Epub 2017 Jun 16.
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.
Lenka A, Pagonabarraga J, Pal PK, Bejr-Kasem H, Kulisevsky J. Minor hallucinations in Parkinson disease: A subtle symptom with major clinical implications. Neurology. 2019 Aug 6;93(6):259-266. doi: 10.1212/WNL.0000000000007913. Epub 2019 Jul 9.
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.
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.
Pagonabarraga J, Soriano-Mas C, Llebaria G, Lopez-Sola M, Pujol J, Kulisevsky J. Neural correlates of minor hallucinations in non-demented patients with Parkinson's disease. Parkinsonism Relat Disord. 2014 Mar;20(3):290-6. doi: 10.1016/j.parkreldis.2013.11.017. Epub 2013 Dec 10.
Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
Andreasen NC, Arndt S, Miller D, Flaum M, Nopoulos P. Correlational studies of the Scale for the Assessment of Negative Symptoms and the Scale for the Assessment of Positive Symptoms: an overview and update. Psychopathology. 1995;28(1):7-17. doi: 10.1159/000284894.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Stiasny-Kolster K, Mayer G, Schafer S, Moller JC, Heinzel-Gutenbrunner M, Oertel WH. The REM sleep behavior disorder screening questionnaire--a new diagnostic instrument. Mov Disord. 2007 Dec;22(16):2386-93. doi: 10.1002/mds.21740.
Beck AT, Baruch E, Balter JM, Steer RA, Warman DM. A new instrument for measuring insight: the Beck Cognitive Insight Scale. Schizophr Res. 2004 Jun 1;68(2-3):319-29. doi: 10.1016/S0920-9964(03)00189-0.
Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
Radakovic R, Abrahams S. Developing a new apathy measurement scale: Dimensional Apathy Scale. Psychiatry Res. 2014 Nov 30;219(3):658-63. doi: 10.1016/j.psychres.2014.06.010. Epub 2014 Jun 19.
Weintraub D, Hoops S, Shea JA, Lyons KE, Pahwa R, Driver-Dunckley ED, Adler CH, Potenza MN, Miyasaki J, Siderowf AD, Duda JE, Hurtig HI, Colcher A, Horn SS, Stern MB, Voon V. Validation of the questionnaire for impulsive-compulsive disorders in Parkinson's disease. Mov Disord. 2009 Jul 30;24(10):1461-7. doi: 10.1002/mds.22571.
Schmitt E, Krack P, Castrioto A, Klinger H, Bichon A, Lhommee E, Pelissier P, Fraix V, Thobois S, Moro E, Martinez-Martin P. The Neuropsychiatric Fluctuations Scale for Parkinson's Disease: A Pilot Study. Mov Disord Clin Pract. 2018 Mar 23;5(3):265-272. doi: 10.1002/mdc3.12607. eCollection 2018 May-Jun.
Pagonabarraga J, Kulisevsky J, Llebaria G, Garcia-Sanchez C, Pascual-Sedano B, Gironell A. Parkinson's disease-cognitive rating scale: a new cognitive scale specific for Parkinson's disease. Mov Disord. 2008 May 15;23(7):998-1005. doi: 10.1002/mds.22007.
Ruff RM, Allen CC, Farrow CE, Niemann H, Wylie T. Figural fluency: differential impairment in patients with left versus right frontal lobe lesions. Arch Clin Neuropsychol. 1994 Jan;9(1):41-55.
Reitan RM, Hom J, Wolfson D. Verbal processing by the brain. J Clin Exp Neuropsychol. 1988 Aug;10(4):400-8. doi: 10.1080/01688638808408248.
Wechsler, D. (2008). Wechsler Adult Intelligence Scale (4th ed.). San Antonio, TX: Pearson Assessment
Cardebat D, Demonet JF, Viallard G, Faure S, Puel M, Celsis P. Brain functional profiles in formal and semantic fluency tasks: a SPECT study in normals. Brain Lang. 1996 Feb;52(2):305-13. doi: 10.1006/brln.1996.0013.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UH_PD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.