Impact of Subthalamic Nucleus Deep Brain Stimulation on COGnitive and PSYchiatric Symptoms in Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • DBS OFF state for left hemisphere

    Other intervention

    DBS is turned off for the left hemisphere during the experiment

  • DBS OFF state for right hemisphere

    Other intervention

    DBS is turned off for the right hemisphere during the experiment

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Experimental Part II, right hemisphere first turned offExperimental treatment 2 interventions
Group B: Experimental Part II, left hemisphere first turned offExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Fluency

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).

Time frame
Baseline visit

Secondary outcomes

1

Impulsivity

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.

Time frame
Baseline visit
2

Neuropsychiatric

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).

Time frame
Baseline visit

Other outcomes

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