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Completed

NCT Number: NCT04577651

Cartesia eXTend 3D Study

The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the treatment of Parkinson's Disease (PD).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Berlin, Charite Virchow Standort, Wedding, Berlin, Germany

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About this study

Subjects will receive Deep Brain Stimulation with a 16-contact Directional Lead to treat their Parkinson's Disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Candidate for DBS implant in the treatment of Parkinson's disease
  • Must be on stable anti-parkinsonian medications for 28 days prior to Informed Consent
  • Persistent disabling Parkinson's disease symptoms such as dyskinesias, motor fluctuations, or disabling "off" periods despite optimal medical therapy
  • Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.).

Key Exclusion Criteria:

  • Any intracranial abnormality or medical condition that would contraindicate DBS surgery
  • Have any significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders)
  • Any current drug or alcohol abuse, as determined by the investigator
  • Any history of recurrent or unprovoked seizures

Treatment and study plan

16-contact Directional Deep Brain Stimulation

Device

Deep Brain Stimulation with 16-contact Directional Lead

Primary outcomes

  1. Change in Motor Function

    Time frame: 12 weeks post device-activation

    Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline in meds off condition to 12 weeks post device-activation in stim on/meds off condition. Range 0 - 108. Higher scores indicate worse function.

Secondary outcomes

  1. Change in Motor Function

    Time frame: 26 weeks post device-activation

    Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 26 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.

  2. Change in Motor Function

    Time frame: 52 weeks post device-activation

    Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 52 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.

  3. Change in Quality of Life

    Time frame: 12 weeks post device-activation

    Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 12 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health.

  4. Change in Quality of Life

    Time frame: 26 weeks post device-activation

    Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 26 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health.

  5. Change in Quality of Life

    Time frame: 52 weeks post device-activation

    Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 52 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Study to Evaluate Boston Scientific Vercise Cartesia 16-contact Directional Lead (X/HX) With Deep Brain Stimulation (DBS) Systems for the Treatment of Parkinson's Disease (PD)

Acronym: eXTend 3D

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Oct 8, 2020
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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