Trial Outcomes & Findings for Cartesia eXTend 3D Study (NCT NCT04577651)
NCT ID: NCT04577651
Last Updated: 2025-02-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
12 weeks post device-activation
Results posted on
2025-02-21
Participant Flow
Participant milestones
| Measure |
16-contact Directional Deep Brain Stimulation
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
16-contact Directional Deep Brain Stimulation
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Overall Study
Screen Failure
|
7
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Cartesia eXTend 3D Study
Baseline characteristics by cohort
| Measure |
16-contact Directional Deep Brain Stimulation
n=49 Participants
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
17 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=5 Participants
|
|
MDS-UPDRS-III score (meds off condition)
|
47.9 units on a scale
STANDARD_DEVIATION 12.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post device-activationPopulation: Intent to treat population.
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.
Outcome measures
| Measure |
16-contact Directional Deep Brain Stimulation
n=49 Participants
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Change in Motor Function
|
-19.9 units on a scale
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 26 weeks post device-activationPopulation: Intent to treat population
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.
Outcome measures
| Measure |
16-contact Directional Deep Brain Stimulation
n=45 Participants
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Change in Motor Function
|
-21.4 units on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: 52 weeks post device-activationPopulation: Intent to treat population
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.
Outcome measures
| Measure |
16-contact Directional Deep Brain Stimulation
n=41 Participants
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Change in Motor Function
|
-21.2 score on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: 12 weeks post device-activationPopulation: Intent to Treat population
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.
Outcome measures
| Measure |
16-contact Directional Deep Brain Stimulation
n=48 Participants
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Change in Quality of Life
|
-6.1 units on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 26 weeks post device-activationPopulation: Intent to Treat population
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.
Outcome measures
| Measure |
16-contact Directional Deep Brain Stimulation
n=46 Participants
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Change in Quality of Life
|
-5.3 units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 52 weeks post device-activationPopulation: Intent to Treat population
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.
Outcome measures
| Measure |
16-contact Directional Deep Brain Stimulation
n=42 Participants
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Change in Quality of Life
|
-6.4 units on a scale
Standard Deviation 11.5
|
Adverse Events
16-contact Directional Deep Brain Stimulation
Serious events: 14 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
16-contact Directional Deep Brain Stimulation
n=58 participants at risk
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Gastrointestinal disorders
Enterovesical fistula
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Gastrointestinal disorders
Ileus
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
General disorders
Implant site paraesthesia
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Infections and infestations
Epididymitis
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Infections and infestations
Pneumonia
|
3.4%
2/58 • Number of events 2 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Infections and infestations
Urosepsis
|
3.4%
2/58 • Number of events 4 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Injury, poisoning and procedural complications
Wound
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.4%
2/58 • Number of events 2 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Nervous system disorders
Brain oedema
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Nervous system disorders
Cerebral Ischaemia
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Nervous system disorders
Fine motor skill dysfunction
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Nervous system disorders
Hyperkinesia
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Nervous system disorders
Parkinson's disease
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Psychiatric disorders
Delirium
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Psychiatric disorders
Dopamine dysregulation syndrome
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Psychiatric disorders
Impulse-control disorder
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
1.7%
1/58 • Number of events 1 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
Other adverse events
| Measure |
16-contact Directional Deep Brain Stimulation
n=58 participants at risk
Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.2%
3/58 • Number of events 3 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Nervous system disorders
Parkinson's disease
|
5.2%
3/58 • Number of events 3 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Nervous system disorders
Paraesthesia
|
6.9%
4/58 • Number of events 4 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Nervous system disorders
Dyskinesia
|
5.2%
3/58 • Number of events 3 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
4/58 • Number of events 8 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
General disorders
Implant site pain
|
8.6%
5/58 • Number of events 5 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
|
Gastrointestinal disorders
Dysphagia
|
5.2%
3/58 • Number of events 3 • Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
|
Additional Information
Sr. Director, Clinical Operations
Boston Scientific Corporation
Phone: 855-213-9890
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER