Brain Targets & Leads

  Counts
Total Number Participants 188
Participants with Unilateral Leads 3
Participants with Bilateral Leads 164
Participants with Dual Leads 9
Total Number of DBS Leads 372
Total Number Explants 9
Target Participant Count Lead Count Explants
ALIC-NA 8 16
Anterior GPi 50 100
CM/PFc Thalamus 94 188 9
Posterior GPi 34 68

Cases Where Multiple Targets Were Implanted

Targets Count of Patients
ALIC-NA Anterior GPi CM/PFc Thalamus Posterior GPi  
Y Y 0
Y Y Y 1
Y Y Y Y 0
Y Y Y 0
Y Y 3
Y Y Y 0
Y Y 0
Y Y 4
Y Y Y 0
Y Y 0
Y Y 1















Adverse Events Chart List


Timepoint
6 Month
All Targets ALIC-NAAnterior GPiCM/PFc ThalamusPosterior GPi
n ( 137 ) subjects ( 42 ) % {Total Cohort} n ( 0 ) subjects ( 0 ) % n ( 23 ) subjects ( 8 ) % n ( 65 ) subjects ( 23 ) % n ( 59 ) subjects ( 14 ) %
Explants 1 1 2.38% 000.00%000.00%114.35%000.00%
Infections 2 2 4.76% 000.00%000.00%228.70%000.00%
Hemorrhages 2 2 4.76% 000.00%000.00%114.35%117.14%
Programming Related 112 34 80.95% 000.00%10337.50%441773.91%5814100.00%
Other Adverse Events 132 42 100.00% 000.00%238100.00%6123100.00%5814100.00%
Click to Show Other Adverse Events Details
 
All Targets
n ( # ) Number of adverse events by category (where # is total number of adverse events).
subjects ( # ) Number of subjects with an adverse event by category
(where # is total number of subjects with leads).
% {Total Cohort} Total number of leads with an adverse event out of total subjects.
Individual Target
n ( # ) Number of adverse events by category for the target (where # is total number of adverse events for the target).
subjects ( # ) Number of participants with an adverse event and the target by category
(where # is total number of participants with the target).
% Percent of total number of participants with the target by category.
Timepoint
1 Year
All Targets ALIC-NAAnterior GPiCM/PFc ThalamusPosterior GPi
n ( 158 ) subjects ( 49 ) % {Total Cohort} n ( 0 ) subjects ( 0 ) % n ( 24 ) subjects ( 8 ) % n ( 77 ) subjects ( 28 ) % n ( 67 ) subjects ( 16 ) %
Explants 1 1 2.04% 000.00%000.00%113.57%000.00%
Infections 5 4 8.16% 000.00%000.00%5414.29%000.00%
Hemorrhages 2 2 4.08% 000.00%000.00%113.57%116.25%
Programming Related 129 38 77.55% 000.00%11337.50%521967.86%6616100.00%
Other Adverse Events 150 48 97.96% 000.00%248100.00%702796.43%6616100.00%
Click to Show Other Adverse Events Details
 
All Targets
n ( # ) Number of adverse events by category (where # is total number of adverse events).
subjects ( # ) Number of subjects with an adverse event by category
(where # is total number of subjects with leads).
% {Total Cohort} Total number of leads with an adverse event out of total subjects.
Individual Target
n ( # ) Number of adverse events by category for the target (where # is total number of adverse events for the target).
subjects ( # ) Number of participants with an adverse event and the target by category
(where # is total number of participants with the target).
% Percent of total number of participants with the target by category.
Timepoint
2 Year
All Targets ALIC-NAAnterior GPiCM/PFc ThalamusPosterior GPi
n ( 184 ) subjects ( 53 ) % {Total Cohort} n ( 0 ) subjects ( 0 ) % n ( 27 ) subjects ( 8 ) % n ( 88 ) subjects ( 31 ) % n ( 79 ) subjects ( 17 ) %
Explants 6 5 9.43% 000.00%000.00%6516.13%000.00%
Infections 7 6 11.32% 000.00%000.00%7619.35%000.00%
Hemorrhages 2 2 3.77% 000.00%000.00%113.23%115.88%
Programming Related 152 42 79.25% 000.00%14337.50%612270.97%7717100.00%
Other Adverse Events 169 51 96.23% 000.00%278100.00%742993.55%7817100.00%
Click to Show Other Adverse Events Details
 
All Targets
n ( # ) Number of adverse events by category (where # is total number of adverse events).
subjects ( # ) Number of subjects with an adverse event by category
(where # is total number of subjects with leads).
% {Total Cohort} Total number of leads with an adverse event out of total subjects.
Individual Target
n ( # ) Number of adverse events by category for the target (where # is total number of adverse events for the target).
subjects ( # ) Number of participants with an adverse event and the target by category
(where # is total number of participants with the target).
% Percent of total number of participants with the target by category.
Timepoint
3 Year
All Targets ALIC-NAAnterior GPiCM/PFc ThalamusPosterior GPi
n ( 197 ) subjects ( 54 ) % {Total Cohort} n ( 0 ) subjects ( 0 ) % n ( 30 ) subjects ( 8 ) % n ( 88 ) subjects ( 31 ) % n ( 89 ) subjects ( 18 ) %
Explants 7 6 11.11% 000.00%000.00%6516.13%115.56%
Infections 7 6 11.11% 000.00%000.00%7619.35%000.00%
Hemorrhages 2 2 3.70% 000.00%000.00%113.23%115.56%
Programming Related 165 43 79.63% 000.00%17337.50%612270.97%8718100.00%
Other Adverse Events 181 51 94.44% 000.00%308100.00%742993.55%871794.44%
Click to Show Other Adverse Events Details
 
All Targets
n ( # ) Number of adverse events by category (where # is total number of adverse events).
subjects ( # ) Number of subjects with an adverse event by category
(where # is total number of subjects with leads).
% {Total Cohort} Total number of leads with an adverse event out of total subjects.
Individual Target
n ( # ) Number of adverse events by category for the target (where # is total number of adverse events for the target).
subjects ( # ) Number of participants with an adverse event and the target by category
(where # is total number of participants with the target).
% Percent of total number of participants with the target by category.
Timepoint
4 Year
All Targets ALIC-NAAnterior GPiCM/PFc ThalamusPosterior GPi
n ( 218 ) subjects ( 57 ) % {Total Cohort} n ( 0 ) subjects ( 0 ) % n ( 38 ) subjects ( 8 ) % n ( 91 ) subjects ( 33 ) % n ( 99 ) subjects ( 19 ) %
Explants 10 9 15.79% 000.00%000.00%7618.18%3315.79%
Infections 8 7 12.28% 000.00%000.00%8721.21%000.00%
Hemorrhages 2 2 3.51% 000.00%000.00%113.03%115.26%
Programming Related 184 45 78.95% 000.00%25337.50%632369.70%9619100.00%
Other Adverse Events 198 52 91.23% 000.00%388100.00%753090.91%951789.47%
Click to Show Other Adverse Events Details
 
All Targets
n ( # ) Number of adverse events by category (where # is total number of adverse events).
subjects ( # ) Number of subjects with an adverse event by category
(where # is total number of subjects with leads).
% {Total Cohort} Total number of leads with an adverse event out of total subjects.
Individual Target
n ( # ) Number of adverse events by category for the target (where # is total number of adverse events for the target).
subjects ( # ) Number of participants with an adverse event and the target by category
(where # is total number of participants with the target).
% Percent of total number of participants with the target by category.
Timepoint
5 Year
All Targets ALIC-NAAnterior GPiCM/PFc ThalamusPosterior GPi
n ( 270 ) subjects ( 65 ) % {Total Cohort} n ( 7 ) subjects ( 3 ) % n ( 53 ) subjects ( 8 ) % n ( 106 ) subjects ( 40 ) % n ( 119 ) subjects ( 19 ) %
Explants 13 12 18.46% 1133.33%000.00%10922.50%3315.79%
Infections 13 12 18.46% 2266.67%000.00%121127.50%000.00%
Hemorrhages 2 2 3.08% 000.00%000.00%112.50%115.26%
Programming Related 235 52 80.00% 73100.00%40337.50%772972.50%11619100.00%
Other Adverse Events 242 59 90.77% 43100.00%538100.00%833690.00%1151789.47%
Click to Show Other Adverse Events Details
 
All Targets
n ( # ) Number of adverse events by category (where # is total number of adverse events).
subjects ( # ) Number of subjects with an adverse event by category
(where # is total number of subjects with leads).
% {Total Cohort} Total number of leads with an adverse event out of total subjects.
Individual Target
n ( # ) Number of adverse events by category for the target (where # is total number of adverse events for the target).
subjects ( # ) Number of participants with an adverse event and the target by category
(where # is total number of participants with the target).
% Percent of total number of participants with the target by category.