N/A
Completed N=58
Cartesia eXTend 3D Study
Source: ClinicalTrials.gov NCT04577651 ↗Enrolled (actual)
58
Serious AEs
24.1%
Results posted
Mar 2024
Primary outcomePrimary: Change in Motor Function — -19.9 units on a scale
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Motor Function |
-21.2 | — |
| SECONDARY Change in Motor Function |
-21.2 | — |
| SECONDARY Change in Quality of Life |
-6.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04577651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.