Parkinsons Disease (PD)
Conditions
Keywords
Deep Brain Stimulation, Neuropsychiatric symptoms, Cognition
Brief summary
With this study, the investigators want to investigate how deep brain stimulation (DBS) affects various cognitive and psychiatric symptoms of Parkinson's disease (PD). In particular, they will examine whether stimulation of the left hemisphere has a different effect than stimulation of the right hemisphere on cognitive and psychiatric symptoms.
Detailed description
Previous studies have shown that motor symptoms improve with DBS in PD. It is also know that DBS can have an effect on cognitive and psychiatric symptoms. However, in the studies completed so far, it has not yet been possible to conclusively assess the exact effect of the stimulation itself on various cognitive and psychiatric symptoms. In particular, there is currently no data on how the precise localization of stimulation at the target site-the subthalamic nucleus (STN)-affects cognitive and psychiatric symptoms. It is not yet clear whether electrical stimulation of the right subthalamic nucleus has different effects on cognition and mood than stimulation of the left subthalamic nucleus. The aim of this study is to investigate whether DBS of the left hemisphere affects cognition and mood differently than DBS of the right hemisphere.
Interventions
OTHERDBS OFF state for left hemisphere
DBS is turned off for the left hemisphere during the experiment
OTHERDBS OFF state for right hemisphere
DBS is turned off for the right hemisphere during the experiment
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Parkinson's disease * Treated with subthalamic nucleus deep brain stimulation (STN-DBS) * For part I: General research consent for the analysis of routine clinical data * For part II of the study: ability to provide informed consent * native German or French speaker * Montreal Cognitive Assessment with score ≥ 20
Exclusion criteria
* Atypical Parkinsonism * Other disease affecting the brain (e.g. Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, non-provoked epilepsy, brain tumour, etc.) * Haemorrhage during implantation of STN-DBS, which resulted in permanent cognitive or physical impairment * Schizophrenia, ongoing substance abuse, bipolar disorder or autism * For part II: Severe depressive disorder and/or suicidality * Insufficient quality or lack of brain imaging data pre and/or post STN-DBS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluency | Baseline visit | Change in composite verbal fluency score for left versus right hemispheric stimulation. To calculate the composite verbal fluency score, the standardized z-scores for phonemic and semantic verbal fluency task will be averaged. For the semantic fluency task, participants generate orally as many category names as possible during 2 minutes (German category 1: professions, category 2: hobbies; French category 1: furniture; category 2: fruit). During the phonemic fluency task, participants generate orally as many words as possible beginning with a certain letter while respecting the following rules: no repetition and no word with the same root, and no proper nouns (German: P-words, M-words; French: R-words, V-words). During each condition (right side stimulation OFF and left side stimulation OFF), one semantic fluency task and one phonemic fluency task will be performed (making sure the same letter and cateogry are only assessed once). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impulsivity | Baseline visit | Change for left versus right hemispheric stimulation in composite impulsivity score. The impulsivity score will be calculated by averaging the standardized z-values for a computerized Go/No-Go task (reaction time and mistakes) and a Stroop Task (inhibition time and mistakes). The Go/NoGo subtests measures selective attention and motor impulsivity. Subjects have to react as quickly as possible when they see a cross on the screen (x), but not when they see a plus sign (+). Both speed and number of mistakes are measured. The interference subtest of the Stroop test measures inhibitory control and selective attention. In the task, participants see color words (e.g., "RED," "BLUE," "GREEN") printed in a conflicting ink color. They are instructed to name the ink color rather than read the word. Time and number of mistakes are measured. |
| Neuropsychiatric | Baseline visit | Change for left versus right hemispheric stimulation in Neuropsychiatric Fluctuation Scale (NFS). The Neuropsychiatric Fluctuations Scale for Parkinson's Disease is a self-report questionnaire. The NFS includes 10 items evaluating OFF neuropsychiatric symptoms and 10 items evaluating ON neuropsychiatric symptoms. Each item is rated from 0 to 3. The total score of the NFS ranges from 0-60, with higher scores indicating better mood. The NFS will be admistered once during each intervention (stimulation right side OFF and stimulation left side OFF). |
Countries
Switzerland
Contacts
CONTACTDeborah Amstutz, PhD
CONTACTMario Sousa, MD
Outcome results
None listed