ClinicalTrials.gg
RecruitingNCT07777419PD-COGPSY-DBSUpdated Sep 4, 2026

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

An interventional study of DBS OFF state for left hemisphere and DBS OFF state for right hemisphere in Parkinsons Disease (PD), sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Parkinson Disease by Insel Gruppe AG, University Hospital Bern — 6 open to participants now, 7 under way, none of them phase 3. Parkinson Disease · Insel Gruppe AG, University Hospital Bern.

Started
2026
the only one that year
No phase
7 of 10
5 open now
Registered
10th of 10
by date

Among the 10 studies in Parkinson Disease by Insel Gruppe AG, University Hospital Bern, this one is the only one that started in 2026, is one of 7 with no phase, and was the 10th registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

6 of the 10 studies in Parkinson Disease by Insel Gruppe AG, University Hospital Bern are open now, in 8 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Parkinson Disease by Insel Gruppe AG, University Hospital Bern, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Parkinsons Disease (PD)

Browse trials for

Keywords

  • Deep Brain Stimulation
  • Neuropsychiatric symptoms
  • Cognition
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • native German or French speaker
  • with score ≥ 20

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Experimental Part II, right hemisphere first turned off

    Parkinson's disease patients of Part II, in whom the right hemisphere is first turned off

    Other: DBS OFF state for left hemisphere · Other: DBS OFF state for right hemisphere

  • Experimental
    Experimental Part II, left hemisphere first turned off

    Parkinson's disease patients of Part II, in whom the left hemisphere is first turned off

    Other: DBS OFF state for left hemisphere · Other: DBS OFF state for 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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.

Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 23 months is close to that.

Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 20, 2026
StartActual
Aug 1, 2026
Primary completionEst.
Jul 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07777419
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Aug 1, 2026
Primary completion
Jul 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 4, 2026

Study contacts

Deborah Amstutz, PhD
Contact
deborah.amstutz@insel.ch
+41 31 66 4 05 67
Mario Sousa, MD
Contact
mario.sousa@insel.ch
+41 31 63 2 86 52

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion