NCT07369310

Brief Summary

The goal of this clinical trial is to learn whether an objective, data-guided approach to programming deep brain stimulation (DBS) can improve motor outcomes in people with Parkinson's disease who undergo DBS surgery. The study includes adults aged 30 to 70 years with Parkinson's disease who are candidates for DBS. The main questions it aims to answer are: Does DBS programming based on objective markers (brain imaging and brain signals) reduce the amount of daily time patients spend in the OFF state more than conventional clinical programming? Does this programming approach improve quality of life and motor symptoms compared with standard programming? Researchers will compare conventional DBS programming based on clinical monopolar review with DBS programming guided by electrode location on neuroimaging and beta brain signals recorded from the implanted device, to see if the objective approach leads to better motor control and less OFF time. Participants will: Undergo DBS surgery using a clinically approved DBS system Be randomly assigned to one of two DBS programming strategies Wear inertial sensors at home for several days at different time points to objectively measure motor symptoms Attend scheduled clinical visits for DBS programming and motor and non-motor assessments Have adaptive DBS activated after 3 months and continue follow-up until 6 months after programming begins

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
29mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Sep 2028

First Submitted

Initial submission to the registry

January 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 21, 2026

Last Update Submit

January 26, 2026

Conditions

Parkinson's DiseaseParkinsonParkinsons Disease (PD)Motor FluctuationsDBSDeep Brain Stimulation

Keywords

Parkinson's DiseaseDeep Brain StimulationDBS ProgrammingMonopolar ReviewLocal Field PotentialsBeta OscillationsBrainSenseMedtronic PerceptNeuroimaging-Guided ProgrammingObjective ProgrammingAdaptive Deep Brain StimulatoinWearable SensorsInertial SensorsMotor FluctuationsOFF TimeDyskinesiaNeuromodulationSubthalamic Nucleus

Outcome Measures

Primary Outcomes (1)

  • Change in Daily OFF Time Assessed by Wearable Sensors

    Percentage change in daily time spent in the OFF state, measured objectively using PDMonitor® inertial sensors. OFF time will be quantified from continuous 7-day recordings performed at baseline (preoperative) and at 3 months after initiation of DBS programming. The outcome reflects motor fluctuations in real-life conditions.

    From baseline (preoperative 7-day recording) to 3 months after start of DBS programming

Secondary Outcomes (4)

  • Change in Quality of Life (PDQ-39 Total Score)

    From baseline to 3 months after start of DBS programming

  • Change in Motor Symptoms (MDS-UPDRS Part III)

    From baseline to 3 months after start of DBS programming

  • Change in fluctuation severity (MDS-UPDRS Part IV)

    From baseline and at 3 months after initiation of DBS programming.

  • Change in Non-Motor Symptoms (MDS-NMS)

    From baseline to 3 months after start of DBS programming

Other Outcomes (5)

  • Effect of Adaptive DBS on Daily OFF Time Assessed by Wearable Sensors

    From 3 months to 6 months after start of DBS programming

  • Effect of Adaptive DBS on Quality of Life (PDQ-39 Total Score)

    From 3 months to 6 months after start of DBS programming

  • Effect of Adaptive DBS on Motor Symptoms (MDS-UPDRS Part III)

    From 3 months to 6 months after start of DBS programming

  • +2 more other outcomes

Study Arms (2)

Conventional DBS Programming (Monopolar Review)

ACTIVE COMPARATOR

Participants in this arm will undergo DBS programming using the conventional clinical approach based on monopolar review.

Device: Conventional DBS Programming (Monopolar Review)

Objective-Guided DBS Programming (Imaging + Local Field Potentials)

EXPERIMENTAL

Participants in this arm will undergo DBS programming guided by objective markers. Selection of stimulation contacts will be informed by postoperative anatomical reconstruction of electrode location using Brainlab Elements™ and by beta-band local field potential (LFP) activity recorded with BrainSense™ from the implanted DBS system.

Device: Objective-Guided DBS Programming (Imaging and Local Field Potential-Based)

Interventions

Conventional DBS Programming (Monopolar Review)DEVICE

DBS programming performed using the conventional clinical monopolar review approach. Stimulation contacts and parameters are selected through systematic clinical testing based on clinician assessment of motor benefit and stimulation-related side effects, together with patient-reported symptoms. Programming does not incorporate postoperative electrode localization from neuroimaging or neurophysiological biomarkers. All participants are implanted with a CE-marked DBS system (Percept™ PC or RC with SenSight™ leads), and programming begins approximately 5 weeks after surgery following standard clinical practice. At 3 months after initial programming, Adaptive DBS is activated in all patients.

Conventional DBS Programming (Monopolar Review)
Objective-Guided DBS Programming (Imaging and Local Field Potential-Based)DEVICE

DBS programming guided by objective anatomical and neurophysiological markers. Stimulation contact selection is informed by postoperative electrode reconstruction using Brainlab Elements™ and by LFP activity recorded with BrainSense™ from the implanted DBS system. These objective data are integrated with standard clinical testing to guide programming decisions. All participants are implanted with the same CE-marked DBS system (Percept™ PC or RC with SenSight™ leads), and programming starts approximately 5 weeks after surgery, following the same schedule as the comparator arm. At 3 months after initial programming, Adaptive DBS will be activated in all patients.

Objective-Guided DBS Programming (Imaging + Local Field Potentials)

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30 and 70 years.
  • Confirmed diagnosis of idiopathic Parkinson's disease according to the MDS diagnostic criteria (Postuma et al., 2015).
  • Indication for deep brain stimulation surgery based on CAPSIT-PD criteria.

You may not qualify if:

  • Presence of severe surgical complications (e.g., intracranial hemorrhage, infection).
  • Postoperative adverse events requiring electrode repositioning.
  • Any other medical or neurological condition that could interfere with safe participation in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Related Publications (3)

  • Muller M, van Leeuwen MFC, Hoffmann CF, van der Gaag NA, Zutt R, van der Gaag S, Schouten AC, Contarino MF. From subthalamic local field potentials to the selection of chronic deep brain stimulation contacts in Parkinson's disease - A systematic review. Brain Stimul. 2025 Sep-Oct;18(5):1499-1510. doi: 10.1016/j.brs.2025.08.004. Epub 2025 Aug 11.

    PMID: 40803531BACKGROUND

  • Neumann WJ, Gilron R, Little S, Tinkhauser G. Adaptive Deep Brain Stimulation: From Experimental Evidence Toward Practical Implementation. Mov Disord. 2023 Jun;38(6):937-948. doi: 10.1002/mds.29415. Epub 2023 May 6.

    PMID: 37148553BACKGROUND

  • Shah A, Nguyen TK, Peterman K, Khawaldeh S, Debove I, Shah SA, Torrecillos F, Tan H, Pogosyan A, Lachenmayer ML, Michelis J, Brown P, Pollo C, Krack P, Nowacki A, Tinkhauser G. Combining Multimodal Biomarkers to Guide Deep Brain Stimulation Programming in Parkinson Disease. Neuromodulation. 2023 Feb;26(2):320-332. doi: 10.1016/j.neurom.2022.01.017. Epub 2022 Feb 24.

    PMID: 35219571BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available. De-identified data may be shared upon reasonable request with the study investigators, subject to approval of a methodologically sound proposal, institutional review board approval as applicable, and execution of a data use agreement.

Locations

ES(1)