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NCT04547712: ADAPT-PD

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

Completed NA Results posted Last updated 8 July 2025
What this trial tests

NA trial testing Adaptive DBS in Parkinson Disease in 85 participants. Completed in 2 May 2025.

Timeline
14 December 2020
Primary endpoint
12 January 2023
2 May 2025

Quick facts

Lead sponsorMedtronicNeuro
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment85
Start date14 December 2020
Primary completion12 January 2023
Estimated completion2 May 2025
Sites10 locations across France, Canada, United States, Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

MedtronicNeuro — full company profile →

Who can join

18 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold. Primary · About one month

In the PD Home Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The PD Home Diary was collected at both the cDBS Baseline and aDBS Evaluation Phases. The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS. The pr

GroupValue95% CI
Primary Cohort aDBS Single Threshold78.959.4 – NA
Primary Cohort aDBS Dual Threshold9175.6 – NA
Stimulation Energy Use Secondary · About one month

Total electrical energy delivered (TEED) for aDBS as compared with cDBS, calculated as TEED at aDBS - TEED at cDBS.

GroupValue95% CI
aDBS Single Threshold-22.3-42.0 – -2.6
aDBS Dual Threshold-22.3-48 – 3.3
Safety (Stimulation-related AEs) Secondary · About one month

To characterize stimulation-related adverse events

GroupValue95% CI
Primary Cohort at cDBS Baseline3
Primary Cohort: aDBS Single Threshold Mode8
Primary Cohort: aDBS Dual Threshold Mode5

Adverse events — posted to ClinicalTrials.gov

Time frame: From subject enrollment to subject last visit or subject exit, an average of 15 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Enrollment to Randomization
Serious: 0/85 (0%)
Deaths: 0/85
Primary Cohort aDBS Single Threshold Mode
Serious: 1/35 (3%)
Deaths: 1/35
Primary Cohort aDBS Dual Threshold Mode
Serious: 0/40 (0%)
Deaths: 0/40
Directional Stimulation Cohort aDBS Single Threshold Mode
Serious: 0/13 (0%)
Deaths: 0/13
Directional Stimulation Cohort aDBS Dual Threshold Mode
Serious: 0/15 (0%)
Deaths: 0/15

Serious adverse events (2 terms)

ReactionSystemEnrollment to RandomizationPrimary Cohort aDBS Single…Primary Cohort aDBS Dual T…Directional Stimulation Co…Directional Stimulation Co…
FallInjury, poisoning and procedural complications
Spinal fractureInjury, poisoning and procedural complications
Other adverse events (8 terms — click to expand)

ReactionSystemEnrollment to RandomizationPrimary Cohort aDBS Single…Primary Cohort aDBS Dual T…Directional Stimulation Co…Directional Stimulation Co…
DyskinesiaNervous system disorders
Parkinson's disease (worsening)Nervous system disorders
TremorNervous system disorders
DysarthriaNervous system disorders
DystoniaNervous system disorders
Gait disturbanceGeneral disorders
Freezing phenomenonNervous system disorders
Propulsive gaitGeneral disorders

Most-reported serious reactions: Fall, Spinal fracture.

Data from ClinicalTrials.gov NCT04547712 adverse events section.

Sponsor's own description

The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Sensing data and methodology from the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) clinical trial.
    Stanslaski S, Summers RLS, Tonder L, Tan Y, et al · · 2024 · cited 62× · PMID 39289373 · DOI 10.1038/s41531-024-00772-5
  2. Electrocorticography is superior to subthalamic local field potentials for movement decoding in Parkinson's disease.
    Merk T, Peterson V, Lipski WJ, Blankertz B, et al · · 2022 · cited 60× · PMID 35621994 · DOI 10.7554/elife.75126
  3. Past, Present, and Future of Deep Brain Stimulation: Hardware, Software, Imaging, Physiology and Novel Approaches.
    Frey J, Cagle J, Johnson KA, Wong JK, et al · · 2022 · cited 55× · PMID 35356461 · DOI 10.3389/fneur.2022.825178
  4. Proceedings of the Eighth Annual Deep Brain Stimulation Think Tank: Advances in Optogenetics, Ethical Issues Affecting DBS Research, Neuromodulatory Approaches for Depression, Adaptive Neurostimulation, and Emerging DBS Technologies.
    Vedam-Mai V, Deisseroth K, Giordano J, Lazaro-Munoz G, et al · · 2021 · cited 47× · PMID 33953663 · DOI 10.3389/fnhum.2021.644593
  5. Shared pathway-specific network mechanisms of dopamine and deep brain stimulation for the treatment of Parkinson's disease.
    Binns TS, Köhler RM, Vanhoecke J, Chikermane M, et al · · 2025 · cited 23× · PMID 40234441 · DOI 10.1038/s41467-025-58825-z
  6. Closed-Loop Adaptive Deep Brain Stimulation in Parkinson's Disease: Procedures to Achieve It and Future Perspectives.
    Wang S, Zhu G, Shi L, Zhang C, et al · · 2023 · cited 23× · PMID 37182899 · DOI 10.3233/jpd-225053
  7. Advances in Deep Brain Stimulation: From Mechanisms to Applications.
    Sandoval-Pistorius SS, Hacker ML, Waters AC, Wang J, et al · · 2023 · cited 21× · PMID 37940596 · DOI 10.1523/jneurosci.1427-23.2023
  8. Long-Term Personalized Adaptive Deep Brain Stimulation in Parkinson Disease: A Nonrandomized Clinical Trial.
    Bronte-Stewart HM, Beudel M, Ostrem JL, Little S, et al · · 2025 · cited 16× · PMID 40982287 · DOI 10.1001/jamaneurol.2025.2781

Verify or expand the search:

Other trials of Adaptive DBS

Trials testing the same drug.

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Other MedtronicNeuro trials

Trials by the same sponsor.

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