Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease

NCT07105280 | Not Yet Recruiting

• 1 other identifier: CTRL-PD study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This multi-center pilot study compares conventional DBS (cDBS) and adaptive DBS (aDBS) in Parkinson's disease patients using the Medtronic Percept™ system. The aim of the study is to identify which patients benefit most from aDBS, and to explore patient and LFP signal characteristics as well as stimulation parameters as potential predictors of treatment preference and efficacy. The study utilizes a blinded, randomized N-of-1 trial design, where each patient tests the following:

• Original cDBS settings (cDBS);
• Optimized cDBS settings (O-cDBS);
• Optimized aDBS settings (O-aDBS) Each setting is evaluated for a minimum of 2 and maximum of 7 days at home in a randomized order (patient blinded). The main study outcome consists of the patient's final preference among the three DBS programs: original cDBS, O-cDBS, or O-aDBS. Secondary outcomes focus on differences between cDBS, O-cDBS and O-aDBS regarding the following parameters (among others):
• Quality of life (PDQ-39);
• Patient satisfaction (5-point Likert Scale);
• (Non)-motor fluctuations (MDS-UPDRS-III + MDS-NMS-Q);
• Time spent in "ON"/"OFF" motor phases (symptom diary + MDS-UPDRS IV);
• Time spent experiencing dyskinesia (symptom diary + MDS-UPDRS IV);
• Time spent with the most bothersome symptom (symptom diary + MDSUPDRS IV);
• Stimulation parameters;
• Local field potentials. The study also incorporates real-world home-based assessments using the Experience Sampling Method (ESM) to capture motor and non-motor symptom fluctuations in daily life and identify differences among the three settings.

Conditions

Parkinson's Disease (PD)

Keywords

deep brain stimulation; adaptive therapy; closed-loop therapy; local field potentials; subhtalamic nucleus; parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Patient preference of DBS settings

  The patient's choice for one of the three program options (standard cDBS, O-cDBS, or O-aDBS)

  after the three week trial phase of the study

Secondary Outcomes (14)

• Quality of life per DBS settings

  Reported after each week with one of the DBS settings (at 7 days, 14 days and 21 days)

• General Prompt Experience Sampling Method score per DBS settings

  Reported average daily score within each week with one of the DBS settings (at 1-7 days, 8-14 days and 15-21 days)

• Patient satisfaction per DBS settings

  Reported after each week with one of the DBS settings (at 7 days, 14 days and 21 days)

• Time spent in ON/OFF per DBS settings according to symptom diary

  Reported after each week with one of the DBS settings (at 7 days, 14 days and 21 days)

• Time spent with dyskinesia per DBS setting according to symptom diary

  Reported after each week with one of the DBS settings (at 7 days, 14 days and 21 days)

Other Outcomes (9)

• Cognitive functioning at baseline

  prior to or at study start (no more than 6 months old)

• Disease duration at baseline

  at baseline (start of study participation)

• Age at baseline

  at baseline (start of study participation)

Study Arms (1)

N-of-1 study arm

EXPERIMENTAL

Main study arm where each participant tests conventional DBS, optimized conventional DBS, and optimized adaptive DBS for seven days each, in a blinded and randomized sequence

Device: Conventional DBS; Device: Optimized conventional DBS; Device: Optimized adaptive DBS

Interventions

Conventional DBS DEVICE

Treatment for a minimum of 2 to a maximum of 7 days with the patient's original conventional DBS (cDBS) settings.

N-of-1 study arm

Optimized conventional DBS DEVICE

Treatment for a minimum of 2 to a maximum of 7 days with a previously optimized version of the patient's original conventional DBS (O-cDBS) settings.

N-of-1 study arm

Optimized adaptive DBS DEVICE

Treatment for a minimum of 2 to a maximum of 7 days with previously optimized adaptive DBS (O-aDBS) settings.

N-of-1 study arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Parkinson's disease with bilateral DBS in the STN
• DBS surgery with implantation of the Percept™ PC/RC system performed at least 6 months ago
• Symptoms such as dysarthria, freezing, or ON-OFF fluctuations that are insufficiently controlled
• A usable LFP signal is present on at least one side

You may not qualify if:

• Patients for whom switching to aDBS, operating the remote control independently, or making regular visits to the DBS center is deemed clinically unsafe or unreliable by the treating physician - for example, due to active or unstable cognitive or psychiatric conditions.
• High impedance, defective DBS electrodes, or insufficient LFP signal quality, or bilateral stimulation primarily on the most ventral or dorsal contact points, preventing proper functioning of aDBS.
• Patients who have objected to the use of their electronic health record data for medical scientific research.

Sponsors & Collaborators

• HagaZiekenhuis: lead
• Maastricht University Medical Center: collaborator
• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC): collaborator

Study Sites (2)

Amsterdam UMC

Amsterdam, 1105AZ, Netherlands

Location

Maastricht UMC+

Maastricht, 6229HX, Netherlands

Location

Related Publications (2)

• Bronte-Stewart H, Beudel M, Ostrem J, Little S, Almeida L, Zamora AR, et al. Chronic Adaptive DBS Provides Similar "On" Time with Trend of Improvement Compared to Continuous DBS in Parkinson's Disease and 98% of Participants Chose to Remain on aDBS (S2.008). Neurology (internet). 2024 Apr 9;102(17_supplement_1). Available from: https://doi.org/10.1212/wnl.0000000000204762

  BACKGROUND

• Nakajima A, Shimo Y, Fuse A, Tokugawa J, Hishii M, Iwamuro H, Umemura A, Hattori N. Case Report: Chronic Adaptive Deep Brain Stimulation Personalizing Therapy Based on Parkinsonian State. Front Hum Neurosci. 2021 Aug 13;15:702961. doi: 10.3389/fnhum.2021.702961. eCollection 2021.

  PMID: 34483867 BACKGROUND

Related Links

• Description Medtronic Percept System (conventioal/adaptive DBS system used in this research)

Study Officials

• Maria Fiorella Contarino, MD, PhD

  HagaZiekenhuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Fiorellla Contarino, MD, PhD

CONTACT

+31 (0)70 210 2997; m.contarino@hagaziekenhuis.nl

Marjolein Muller, Msc

CONTACT

+31 (0)70 210 2997; ma.muller@hagaziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients are not masked for the group they are in, but they are blinded for the order in which they receive treatment with three different deep brain stimulation settings.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: An N-of-1 trial design in which each patient tests conventional DBS, optimized conventional DBS, and optimized adaptive DBS for seven days each, in a blinded and randomized sequence.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-07

Locations

NL (2)