Trial Outcomes & Findings for Clinical Evaluation of the Infinity Deep Brain Stimulation System (NCT NCT02989610)
NCT ID: NCT02989610
Last Updated: 2024-08-22
Results Overview
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.
Recruitment status
COMPLETED
Target enrollment
234 participants
Primary outcome timeframe
3-month follow-up visit after initial programming
Results posted on
2024-08-22
Participant Flow
This prospective, blinded-subject, blinded-evaluator, observational, multi-center 12-month post-market clinical follow-up study study enrolled a total of 234 participants between January 2017 and January 2019 at 37 sites in Europe, the U.S. and Australia. Of which 82 participants completed 36 months follow-up visit.
Participant milestones
| Measure |
Omnidirectional Followed by Directional DBS
Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
|
|---|---|
|
Overall Study
STARTED
|
234
|
|
Overall Study
COMPLETED
|
184
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Omnidirectional Followed by Directional DBS
Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
20
|
|
Overall Study
Departure of PI from Site
|
8
|
|
Overall Study
Subject Participation Terminated by Investigator
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Death
|
3
|
|
Overall Study
System Explant
|
3
|
|
Overall Study
Subject Non-Compliance
|
2
|
|
Overall Study
System Revision
|
2
|
|
Overall Study
PI Left, Study Closing
|
1
|
|
Overall Study
Site Discontinued Participation in the Study
|
1
|
|
Overall Study
Unable to Complete Visit Due to PI Leaving University
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Omnidirectional Followed by Directional DBS
n=234 Participants
Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated.
At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
|
|---|---|
|
Age, Continuous
|
61.7 Years
STANDARD_DEVIATION 8.4 • n=234 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=234 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=234 Participants
|
|
Region of Enrollment
United States
|
90 Participants
n=234 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=234 Participants
|
|
Region of Enrollment
Germany
|
62 Participants
n=234 Participants
|
|
Region of Enrollment
Spain
|
43 Participants
n=234 Participants
|
|
Region of Enrollment
Australia
|
15 Participants
n=234 Participants
|
|
Region of Enrollment
Poland
|
19 Participants
n=234 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=234 Participants
|
|
Duration of Parkinson Symptoms
|
11.2 Years
STANDARD_DEVIATION 4.9 • n=234 Participants
|
PRIMARY outcome
Timeframe: 3-month follow-up visit after initial programmingPopulation: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.
Outcome measures
| Measure |
Omnidirectional Followed by Directional DBS
n=204 Participants
Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
|
|---|---|
|
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
|
185 Participants
|
SECONDARY outcome
Timeframe: 3-month follow-up visit after initial programmingPopulation: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control.
Outcome measures
| Measure |
Omnidirectional Followed by Directional DBS
n=204 Participants
Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
|
|---|---|
|
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority)
|
185 Participants
|
SECONDARY outcome
Timeframe: 3 and 6 Months Follow-Up VisitsPopulation: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment.
Outcome measures
| Measure |
Omnidirectional Followed by Directional DBS
n=181 Participants
Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
|
|---|---|
|
Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months
Omnidirectional stimulation (3 months)
|
25.1 Score on a scale
Standard Deviation 12.8
|
|
Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months
Directional stimulation (6 months)
|
30.8 Score on a scale
Standard Deviation 14.0
|
Adverse Events
Omnidirectional Followed by Directional DBS
Serious events: 34 serious events
Other events: 32 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Omnidirectional Followed by Directional DBS
n=234 participants at risk
Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated.
At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
|
|---|---|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
0.43%
1/234 • 36 Months
|
|
Blood and lymphatic system disorders
Edema
|
0.43%
1/234 • 36 Months
|
|
Blood and lymphatic system disorders
Traumatic Psoas Bleed
|
0.43%
1/234 • 36 Months
|
|
Endocrine disorders
Endocrinological Issues
|
0.43%
1/234 • 36 Months
|
|
Gastrointestinal disorders
Appendicitis with Perforation
|
0.43%
1/234 • 36 Months
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.43%
1/234 • 36 Months
|
|
General disorders
Chest Pain
|
0.43%
1/234 • 36 Months
|
|
General disorders
Coma Related to Drowning
|
0.43%
1/234 • 36 Months
|
|
General disorders
Fall at Home
|
0.43%
1/234 • 36 Months
|
|
General disorders
Fracture of Vertebrae
|
0.43%
1/234 • 36 Months
|
|
General disorders
Several Falls
|
0.43%
1/234 • 36 Months
|
|
General disorders
Spinal Cord Canal Stenosis
|
0.43%
1/234 • 36 Months
|
|
General disorders
TLOC (Transient Loss of Consciousness)
|
0.43%
1/234 • 36 Months
|
|
Infections and infestations
Sepsis Secondary to Influenza Infection
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Battery Failure Within the Device
|
0.85%
2/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Extension Fracture
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Lead Fracture
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Loss of Therapeutic Benefit - Change in Electrode Positions
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Speech or Language Impairment - Aphasia
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Speech or Language Impairment - Dysphagia
|
0.43%
1/234 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Dystonia
|
0.43%
1/234 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma of Scalp and Squamous Cell Carcinoma
|
0.43%
1/234 • 36 Months
|
|
Nervous system disorders
Worsening of Motor/Parkinson's Disease Symptoms - Abnormal Gait
|
0.43%
1/234 • 36 Months
|
|
Nervous system disorders
Worsening of Motor/Parkinson's Disease Symptoms - Tremor
|
0.43%
1/234 • 36 Months
|
|
Psychiatric disorders
Cognitive impairment - Confusion
|
0.43%
1/234 • 36 Months
|
|
Psychiatric disorders
Cognitive impairment - Disorientation
|
0.43%
1/234 • 36 Months
|
|
Psychiatric disorders
Depression
|
0.43%
1/234 • 36 Months
|
|
Psychiatric disorders
Dopamine Dysregulation Syndrome
|
0.43%
1/234 • 36 Months
|
|
Psychiatric disorders
Suicide
|
0.43%
1/234 • 36 Months
|
|
Renal and urinary disorders
Renal Failure
|
0.43%
1/234 • 36 Months
|
|
Renal and urinary disorders
Renal Stones with Secondary Sepsis
|
0.43%
1/234 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Hypoxic Respiratory Failure
|
0.43%
1/234 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.85%
2/234 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Erosion
|
0.43%
1/234 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Erosion Due to Undiagnosed Dermatologic Disorder
|
0.43%
1/234 • 36 Months
|
|
Surgical and medical procedures
Bioprosthetic Av Replacement
|
0.43%
1/234 • 36 Months
|
Other adverse events
| Measure |
Omnidirectional Followed by Directional DBS
n=234 participants at risk
Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated.
At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.
|
|---|---|
|
Injury, poisoning and procedural complications
Battery Failure Within the Device
|
0.85%
2/234 • 36 Months
|
|
Psychiatric disorders
Cognitive Impairment - Depression
|
0.43%
1/234 • 36 Months
|
|
Psychiatric disorders
Cognitive Impairment - Emotional Lability
|
0.85%
2/234 • 36 Months
|
|
Psychiatric disorders
Cognitive Impairment - Hallucinations
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Decreased Therapeutic Response
|
0.85%
2/234 • 36 Months
|
|
Product Issues
Deep Brain Stimulation System Malfunction
|
0.43%
1/234 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Dyskinetic Dystonia
|
0.43%
1/234 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Dystonia
|
0.43%
1/234 • 36 Months
|
|
General disorders
Headache/Migraine
|
0.43%
1/234 • 36 Months
|
|
Infections and infestations
Impaired Wound Healing - Incision Site Drainage
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Loss of Therapeutic Benefit - Change in Loose Electrical Connections
|
0.43%
1/234 • 36 Months
|
|
Surgical and medical procedures
Persistent Pain at Surgery Site or Ipg Site
|
0.43%
1/234 • 36 Months
|
|
Nervous system disorders
Sensory Disturbance or Impairment - Neuralgia
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Sensory Disturbance or Impairment - Sensory Deficit
|
0.85%
2/234 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath On Exertion
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Skull Discoloration
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Speech or Language Impairment - Dysarthria
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Sub-Optimal Placement of Lead
|
0.43%
1/234 • 36 Months
|
|
Injury, poisoning and procedural complications
Undesirable Changes in Stimulation - Other
|
0.85%
2/234 • 36 Months
|
|
Nervous system disorders
Worsening of Motor/Parkinson's Disease Symptoms - Abnormal Gait
|
0.85%
2/234 • 36 Months
|
|
Nervous system disorders
Worsening of Motor/Parkinson's Disease Symptoms - Bradykinesia
|
0.85%
2/234 • 36 Months
|
|
Nervous system disorders
Worsening of Motor/Parkinson's Disease Symptoms - Dyskinesia
|
3.0%
7/234 • 36 Months
|
|
Nervous system disorders
Worsening of Motor/Parkinson's Disease Symptoms - Motor Fluctuations
|
0.43%
1/234 • 36 Months
|
|
Nervous system disorders
Worsening of Motor/Parkinson's Disease Symptoms - Rigidity
|
0.43%
1/234 • 36 Months
|
|
Nervous system disorders
Worsening of Motor/Parkinson's Disease Symptoms - Tremor
|
2.1%
5/234 • 36 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place