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Testing a new electrode during brain stimulation surgery

Researchers are assessing safety and how precisely a new electrode can direct stimulation.

Learning by observing or collecting information · Study reference: NL-OMON20700

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Results reported

Start (reported date)
2012-10-22

Planned dates can move. A study finishing does not tell us when a paper will be published.

Read the results reported in the registry

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age range not listed · Ask the team who can join

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Read all the rules for taking part

Sex eligibility reported by registry: Not reported

Inclusion criteria: 1. Diagnosis of idiopathic Parkinson's disease; 2. Clinical indication for STN DBS with MER; 3. Age > 18 years; 4. Subject is a male or non-pregnant female; 5. Ability to comply with the study assignments; 6. Ability to give informed consent. Exclusion criteria: 1. Parkinson's disease graded according to Hoehn and Yahr stage 5; 2. Score on MATTIS dementia rating scale <120; 3. Psychiatric contraindications to STN DBS; 4. General contraindications for stereotactic surgery and general anaesthesia (e.g. severe hypertension, blood coagulation disorder); 5. Subject has factors that would put the subject at an additional risk for intra-operative or postoperative bleeding. This includes underlying disorders of the coagulation cascade (eg, hemophilia), disorders that affect platelet count or function (eg, Von Willebrand's disease), as well as administration of any anti-platelet or anti-coagulant medication in the 7 days prior to surgery, or any history of anticoagulant or aspirin use or history of hemorrhagic stroke, that in the view of the neurosurgeon or neurologist would place the subject at an increased risk for intra-operative or postoperative bleeding; 6. Subject has a diagnosis of acute myocardial infarction or cardiac arrest less than or equal to 6 months prior to the screening testing; 7. Subject has a history of a seizure disorder; 8. Subject requires short surgery time due to general health issues, as determined by the investigator; 9. Subject is a woman who is pregnant or planning to become pregnant, or a woman of child-bearing potential, who is not using a medically-acceptable method of birth control. Women of child-bearing potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to the investigational procedure visit.
Full study name & original research details

Official study title

Intra-operative evaluation of efficacy and safety of a new lead for steering Deep Brain Stimulation. First Acute-in-Man Evaluation of Steering Brain Stimulation.

Short title used by the registry

Intra-operative evaluation of efficacy and safety of a new lead for steering Deep Brain Stimulation.

Original description

Intervention: Sapiens Deep brain stimulation lead. Primary outcome: 1. Description of and threshold for effects obtained by stimulation through Sapiens lead in standard mode; 2. Analysis of safety of stimulation with the Sapiens lead compared to control data. Secondary outcome: 1. Description of and threshold for effects obtained by stimulation through Sapiens lead in different modes; 2. Determination and comparison of ""therapeutic window"", obtained by stimulation through Sapiens lead in different modes.

Conditions reported: Parkinson's disease, Deep Brain StimulationZiekte van Parkinson, Diepe Hersenstimulatie

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Observational
Interventions
Sapiens Deep brain stimulation lead.
Phases
Not reported
Sponsor
Sapiens Steering Brain Stimulation B.V.H.C.F. Martens, PhDDirector of Clinical ScienceHigh Tech Campus 485656 AE EindhovenThe NetherlandsTel: +31 40 800 2104
Start date reported by registry
2012-10-22 (reported)

Registry updated: Not reported · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

P.R. Schuurman · +31 (0)20 5669111 · p.r.schuurman@amc.nl

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

No locations reported. Ask the study team where participation is available.

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.