Individualized stimulation parameters in deep brain stimulation for Parkinson's Disease based on disease phenotype and brain connectivity: a feasibility study (iDBS trial)

Individualized stimulation parameters in deep brain stimulation for Parkinson's Disease based on disease phenotype and brain connectivity: a feasibility study (iDBS trial) - PDBS-PD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57446

Enrollment

Registered

2024-07-04

Start date

2026-05-15

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease Parkinson's disease

Interventions

Patients will be randomized to receive either (i) computational DBS programming (n=12) or (ii) conventional trial-and-error based DBS programming (n=12).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: o Patients that are eligible for bilateral STN-DBS surgery for idiopathic PD in  the Radboud university medical center o Patients are implanted with Boston Scientific Cartesia X directional leads. o Patients have given written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: o Any significant medical condition that is likely to interfere with study  procedures. o Participation in any other clinical trial (e.g. drug, device, or biologics)  concurrently or within the preceding 30 days.  

Design outcomes

Primary

Measure	Time frame
The primary endpoints are safety (occurrence of stimulation induced side-effects, duration of induced side effects (temporary or permanent), severity of the stimulation induced side-effects) and technical feasibility (time from surgery to DBS-initiation, time from surgery to reaching optimal DBS stimulation settings) of the computational workflow.	—

Secondary

Measure	Time frame
The secundary endpoints are the practical feasibility of a larger randomized trial (inclusion rate of patients meeting the inclusion criteria, withdrawal/drop-out within the study period, adherence to the research protocol with regard to the DBS programming), difference in UPDRS-III OFF-medication condition before surgery and UPDRS-III OFF-medication ON-stimulation condition at 3, 6 and 12-months follow-up between the two arms, difference in Levodopa Equivalent Daily Dose (LEDD) before surgery and at 3, 6 and 12-months follow-up between the two arms, difference in Parkinson Disease Questionnaire-39 (PDQ-39) before surgery and at 3, 6 and 12-months follow-up between the two arms, number of hospital consultations (by phone or as an outpatient) during the follow-up period, and difference in energy usage of the IPG between the two arms.	—

Measure

Time frame

The secundary endpoints are the practical feasibility of a larger randomized trial (inclusion rate of patients meeting the inclusion criteria, withdrawal/drop-out within the study period, adherence to the research protocol with regard to the DBS programming), difference in UPDRS-III OFF-medication condition before surgery and UPDRS-III OFF-medication ON-stimulation condition at 3, 6 and 12-months follow-up between the two arms, difference in Levodopa Equivalent Daily Dose (LEDD) before surgery and at 3, 6 and 12-months follow-up between the two arms, difference in Parkinson Disease Questionnaire-39 (PDQ-39) before surgery and at 3, 6 and 12-months follow-up between the two arms, number of hospital consultations (by phone or as an outpatient) during the follow-up period, and difference in energy usage of the IPG between the two arms.

—

Countries

Netherlands

Contacts

Public ContactR.S. Vinke

Radboud Universitair Medisch Centrum

Saman.Vinke@radboudumc.nl+31 (0)24 361 64 04

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026