Hallucinations in Parkinson's Disease

Olaf Blanke

Status: Unknown

Conditions: Parkinson Disease Psychosis

Treatments: Other: Resting-state fMRI acquisition; Behavioral: Induction of PH and associated bodily states; Other: Induction of PH and associated bodily states (MRI); Behavioral: Clinical and neuropsychological assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT04592965

UH_PD

Details and patient eligibility

About

Investigation on how robotically mediated sensorimotor stimulation induces and triggers presence hallucinations in different clinical groups of parkinsonian patients, and in aged-matched controls

Full description

Parkinson's Disease (PD) is a condition mostly known and characterized by motor symptoms, such as tremors, rigidity, bradykinesia, amongst others. Yet, recent bodies of research have identified a significant number of non-motor symptoms that also accompany the unfolding of this disease. These non-motor symptoms mainly focus on hallucinations that will develop with the course of the disease, and will affect approximately 50% of the patients suffering from Parkinson's. This number rises to 70% if minor hallucinations, mild phenomena and poorly-structured hallucinations, are included. Despite the potential impact in the patients' lives, and previous efforts to study these phenomena, the brain changes that underly hallucinations in PD are still poorly understood. With the current study the investigators aim to improve this understanding, by studying the most common minor hallucination in Parkinson's Disease, the Presence Hallucination (PH), which can be defined as the strange sensation of perceiving someone behind when no one is actually there. To study it in a controlled manner, the investigators will induce this hallucination with an extensively verified paradigm, which gives rise to this sensation through robotically-mediated sensorimotor stimulation, in both healthy individuals, and PD patients. The researchers intend to discern the sensitivity of different groups of PD patients to the induction of this hallucination, by targeting PD patients, with hallucinations including PH, with hallucinations but without PH, without any hallucinations, and an aged match control group with no neurological comorbidities. The investigators intended to extend previous work on the induction of the PH in PD patients, by identifying the neural correlates of this induction in these patients, in a similar fashion to previous work in healthy individuals. Moreover, the researchers also intend to extend the general understanding of the basis for hallucinations in PD by extending what was done in previous work, to more stratified cohorts of PD patients, that will not only be analysed in terms of static during rest, but also in terms of dynamic connectivity, and will also perform the PH-inducing task in the scanner, as mentioned before.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosed with Parkinson's disease (expect for healthy controls)
• 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 PD patients only: Neurological comorbidities other than Parkinson's disease (e.g. Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, chronic migraine, etc.)
• 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Clinical and neuropsychological examinations

Experimental group

Description:

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.

Treatment:

Behavioral: Clinical and neuropsychological assessments

Robot induced PH, through sensorimotor stimulation

Experimental group

Description:

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.

Treatment:

Behavioral: Induction of PH and associated bodily states

Resting-state fMRI acquistion

Experimental group

Description:

We will acquire resting-state data in the MRI scanner for all the participants. Respiration and heart beat rate data will also be acquired.

Treatment:

Other: Resting-state fMRI acquisition

Robot induced PH, through sensorimotor stimulation (MRI)

Experimental group

Description:

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.

Treatment:

Other: Induction of PH and associated bodily states (MRI)