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Clinical Evaluation of the Infinity Deep Brain Stimulation System (PROGRESS)

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ClinicalTrials.gov Identifier: NCT02989610
Recruitment Status : Active, not recruiting
First Posted : December 12, 2016
Results First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Device: Omnidirectional stimulation
Device: Directional stimulation
Enrollment 234
Recruitment Details The PROGRESS 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 195 participants completed 6 months follow-up visit.
Pre-assignment Details Of the 234 enrolled participants, there were 230 participants who had initial study programming. Out of 212 participants who completed the 3-month visit, there were 202 with complete primary endpoint data. After the 3-month visit, 17 were withdrawn or lost to follow-up, leaving the number of participants completed as of 195 participants.
Arm/Group Title Omnidirectional Followed by Directional DBS
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 234
Completed 195
Not Completed 39
Reason Not Completed
Withdrawal/Other reasons             39
Arm/Group Title Omnidirectional Followed by Directional DBS
Hide Arm/Group Description

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 Number of Baseline Participants 234
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants
61.7  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants
Female
77
  32.9%
Male
157
  67.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 234 participants
90
Italy Number Analyzed 234 participants
4
Germany Number Analyzed 234 participants
62
Spain Number Analyzed 234 participants
43
Australia Number Analyzed 234 participants
15
Poland Number Analyzed 234 participants
19
Belgium Number Analyzed 234 participants
1
Duration of Parkinson Symptoms  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants
11.7  (7.6)
1.Primary Outcome
Title Percentage of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
Hide Description 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.
Time Frame 3-month follow-up visit after initial programming
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects for whom data were available at that time of analysis.
Arm/Group Title Omnidirectional Followed by Directional DBS
Hide Arm/Group Description:
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 Number of Participants Analyzed 66
Measure Type: Count of Participants
Unit of Measure: Participants
59
  89.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omnidirectional Followed by Directional DBS
Comments Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.
Type of Statistical Test Superiority
Comments Superiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 60%.
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Clopper-Pearson method
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Wider Therapeutic Window With Directional Programming (Non-inferiority)
Hide Description 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.
Time Frame 3-month follow-up visit after initial programming
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects for whom data were available at that time of analysis.
Arm/Group Title Omnidirectional Followed by Directional DBS
Hide Arm/Group Description:
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 Number of Participants Analyzed 66
Measure Type: Count of Participants
Unit of Measure: Participants
59
  89.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omnidirectional Followed by Directional DBS
Comments Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 40%.
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Clopper-Pearson method
Comments [Not Specified]
3.Secondary Outcome
Title Change in UPDRS III Score on and Off Stimulation (Medication on) at 3 and 6 Months
Hide Description 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.
Time Frame 3-month and 6-month follow-up visits
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects for whom data were available at that time of analysis.
Arm/Group Title Omnidirectional Followed by Directional DBS
Hide Arm/Group Description:
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 Number of Participants Analyzed 66
Mean (Standard Deviation)
Unit of Measure: score on a scale
Omnidirectional stimulation (3 months) 10.6  (9.1)
Directional stimulation (6 months) 12.8  (12.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omnidirectional Followed by Directional DBS
Comments Comparison of UPDRS part III on medication from 3 months using omnidirectional stimulation to 6 months using directional stimulation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method t-test, 1 sided
Comments Paired t-test.
Time Frame 6 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omnidirectional Followed by Directional DBS
Hide Arm/Group Description

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.

All-Cause Mortality
Omnidirectional Followed by Directional DBS
Affected / at Risk (%)
Total   0/234 (0.00%) 
Hide Serious Adverse Events
Omnidirectional Followed by Directional DBS
Affected / at Risk (%)
Total   25/234 (10.68%) 
Cardiac disorders   
Mitral valve replacement  1  1/234 (0.43%) 
Endocrine disorders   
Endocrinological issues  1  1/234 (0.43%) 
Gastrointestinal disorders   
Appendicitis  1  1/234 (0.43%) 
Umbilical hernia  1  1/234 (0.43%) 
General disorders   
Falls requiring hospitalization  1  1/234 (0.43%) 
Infections and infestations   
Sepsis secondary to influenza  1  1/234 (0.43%) 
Injury, poisoning and procedural complications   
Battery depletion resulting in hospitalization  1  1/234 (0.43%) 
Cognitive impairment: Confusion  1  1/234 (0.43%) 
Cognitive impairment: Disorientation  1  1/234 (0.43%) 
Edema near site of lead  1  1/234 (0.43%) 
Erosion  1  1/234 (0.43%) 
Extension breakage in a swimmer  1  1/234 (0.43%) 
Lead fracture due to trauma  1  1/234 (0.43%) 
Loss of therapeutic benefit: Lead migration  1  1/234 (0.43%) 
Speech or language impairment: Aphasia  1  1/234 (0.43%) 
Speech or language impairment: Dysphagia  1  1/234 (0.43%) 
Worsening of Parkinson's motor symptoms: Tremor  1  1/234 (0.43%) 
Musculoskeletal and connective tissue disorders   
Knee operation  1  1/234 (0.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma and squamous cell carcinoma  1  1/234 (0.43%) 
Nervous system disorders   
Coma related to drowning  1  1/234 (0.43%) 
Dopamine dysregulation syndrome  1  1/234 (0.43%) 
Transient loss of consciousness  1  1/234 (0.43%) 
Psychiatric disorders   
Depression  1  1/234 (0.43%) 
Skin and subcutaneous tissue disorders   
Erosion related to dermatological disorder  1  1/234 (0.43%) 
Surgical and medical procedures   
Spinal cord canal stenosis  1  1/234 (0.43%) 
1
Term from vocabulary, MedDRA 11.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Omnidirectional Followed by Directional DBS
Affected / at Risk (%)
Total   25/234 (10.68%) 
Injury, poisoning and procedural complications   
Worsening of Parkinson's motor symptoms: Dyskinesia  1  5/234 (2.14%) 
Worsening of Parkinson's motor symptoms: Tremor  2  4/234 (1.71%) 
Decreased therapeutic response  2  2/234 (0.85%) 
Cognitive impairment: Emotional lability  2  2/234 (0.85%) 
Sensory disturbance or impairment: Neuralgia  2  1/234 (0.43%) 
Sensory disturbance or impairment: Sensory deficit  2  2/234 (0.85%) 
Undesirable changes in stimulation  2  2/234 (0.85%) 
Worsening of Parkinson's motor symptoms: Abnormal gait  2  2/234 (0.85%) 
Worsening of Parkinson's motor symptoms: Bradykinesia  2  2/234 (0.85%) 
Cognitive impairment: Hallucination  2  1/234 (0.43%) 
Dystonia  2  1/234 (0.43%) 
Erosion  2  1/234 (0.43%) 
Impaired wound healing: Incision site drainage  2  1/234 (0.43%) 
Sensory disturbance or impairment: Neuropathy  2  1/234 (0.43%) 
Speech or language impairment: Dysarthria  2  1/234 (0.43%) 
Skull discoloration  2  1/234 (0.43%) 
Suboptimal placement of lead corrected during IPG implant  2  1/234 (0.43%) 
High impedance  1  1/234 (0.43%) 
1
Term from vocabulary, MedRA 11.0
2
Term from vocabulary, MedDRA 11.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edward Karst, Clinical Research Director
Organization: Abbott
Phone: +1 9725264663
EMail: Edward.karst@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02989610    
Other Study ID Numbers: SJM-CIP-10061
First Submitted: December 8, 2016
First Posted: December 12, 2016
Results First Submitted: September 4, 2020
Results First Posted: November 19, 2020
Last Update Posted: November 19, 2020