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NCT Number: NCT07777419

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBS OFF state for left hemisphere

Other

DBS is turned off for the left hemisphere during the experiment

DBS OFF state for right hemisphere

Other

DBS is turned off for the right hemisphere during the experiment

Primary outcomes

  1. Fluency

    Time frame: 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 outcomes

  1. Impulsivity

    Time frame: 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.

  2. Neuropsychiatric

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Amstutz, PhD

CONTACT

[email protected]

+41 31 66 4 05 67

Mario Sousa, MD

CONTACT

[email protected]

+41 31 63 2 86 52

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: PD-COGPSY-DBS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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