Peripheral Nerve Stimulation of the

Occipital Nerves for Chronic Migraine

Clinical Study Results
Neuromodulation Division
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.
Patient
Enrolled
PNS
Implanted
Randomize and
Device Activation
Group A: Active
Group B: Control (Blind)
2:1 Ratio
Clinical Study Design
52-week visit 24-week visit 12-week visit 4-week visit 80- to 90-day roll in
The integrity of the Control (or blind) group was maintained as:

1/ Both patients in the Control group, and the study investigator were blinded, so nobody knew
who was active or control
2/ All Control patients were given programmers that appeared to be functioning, but did not
communicate with the IPG (for the first 12 weeks).
3/ Patients in the control group were told that a range of different settings were being
tested which was not indicative of whether they were in the control or active group.

Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.
Clinical Study Design
Study Inclusion Criteria
Diagnosed with chronic migraine
headache or probable migraine with <15
headache days/month
Has tried at least 2 migraine-specific
acute medications and at least 2
different classes of prophylactic
medications and found to be refractory
VAS score of 6 cm (or greater)
on a 10-cm line
Headache pain is posterior head pain or
pain originating in the cervical region
Study Exclusion Criteria
Patients identified as having Medication
Overuse Headache (MOH) - per
assessment by study investigator
Patients who within 8 weeks prior to initial
baseline have started new medications or
therapy to treat headache pain
Patients who had tried Botox who had tried
6 months prior to
initial baseline
Patients who have undergone a destructive
procedure affecting
C2/C3/occipital distribution
Cervical abnormality that does
not allow for placement of the percutaneous
lead
The above inclusion/ exclusion criteria were used in the clinical research to
define the study population for chronic migraine.
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.
Baseline Patient Demographics
Control Group
(N=52)
Active Group
(N=105)
Age
Mean (+std) 44,6 (+ 10,3) 45,0 (+ 11,3)
Range 2365 1872
Gender
Male 9 (17,3%) 24 (22,9%)
Female 43 (82,7%) 81 (77,1%)
Duration of Headache (yrs)
Mean (+std) 24,6 + 13,3 21,9 + 14,9
Range 2,454 1,366
Baseline Number of Headache
Days
(out of 90 From MIDAS
Questionnaire)
Mean (+std) 72,3 (+ 23,5) 80,7 (+ 18,2)
Study participants in the active and control groups were similar at baseline
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.
Results: Primary Endpoint
50% Reduction in Pain on VAS
Continuous Proportion Responder Analysis Based on Mean Daily Average Pain Intensity
VAS Measurements With No Increase in Average Headache Frequency or Duration
Primary Endpoint:
The primary endpoint in the study was a statistical reference point imposed by
the FDA:
10% differential between responders in active group vs. control group
(95% IC) and,
Responders were defined with 50% reduction (or greater) in mean VAS vs.
baseline

Statistically significant and Clinically relevant for Responders defined at 30%.
Based on feedback from our study investigators this outcome is highly significant in
this patient population particularly when you consider the improvement in disability
and quality of life.
Furthermore it is important to note that a 30% reduction in pain is the mark used by
pharmaceutical companies when they assess whether a specific pain treatment is
efficacious or not.
The study primary end point was not met.
Significance was demonstrated at 30% reduction in pain. p-value=0,02
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.
Results: Primary Endpoint
50% Reduction in Pain on Visual Analog Scale
Continuous Proportion Responder Analysis Based on Mean Daily Average Pain Intensity
VAS Measurements With No Increase in Average Headache Frequency or Duration
0%
20%
40%
60%
80%
100%
0% 20% 40% 60% 80% 100%
P
e
r
c
e
n
t
a
g
e

o
f

P
a
t
i
e
n
t
s

Percentage of Pain Reduction
Patients Achieving Various Levels of
Pain Relief
Control (n=52) Active (n=105)
The study primary end point was not met.
Significance was demonstrated at 30% reduction in pain. p-value=0,02
%
reduction
from
baseline
Control
Group %
responder
s (n=52)
Active
Group %
responder
s (n=105)
p-
value
1
met
protocol
objective
(>10%
dif.)
2
10,0% 30,8% 56,2% 0,003 Yes
20,0% 19,2% 40,0% 0,009 Yes
30,0% 17,3% 35,2% 0,020 Yes
40,0% 15,4% 25,7% 0,143 No
50,0% 13,5% 17,1% 0,553 No
60,0% 9,6% 11,4% 0,731 No
70,0% 1,9% 4,8% 0,664 No
80,0% 1,9% 3,8% 1 No
90,0% 0,0% 1,0% 1 No
100,0% 0 0 0 No
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.

Results: Secondary Endpoints
Reduction in Headache Days at the 12-Week
Control Phase (using patient diary)
Visit Control Group (n=52) Active Group (n=105) P-Value
Baseline
Mean ( std) 17,1 ( 8.2) 20,5 ( 7,6) 0,011
Week 12
Mean Change
1
-4,3 (25,1%) -7,3 (35,6%) 0,02
Patient diaries recorded whether or not patients had a headache each day, the daily average
headache intensity, and the daily headache duration, in hours.
Data was used to identify Headache Days, defined as a day with a headache lasting four or
more hours with at least moderate intensity.
Significant reduction -3.0 days in Headache Days (per month) between
Active and Control groups (p=0.02)
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.

Results: Secondary Endpoints
Reduction in MIDAS Disability Score at 12-Week
Control Phase
Visit Control Group (n=52) Active Group (n=105) P-Value
Baseline
Mean ( std) 152,7 ( 77,1) 158,4 ( 76,8) 0,664
Week 12
Mean Change
1
-20,4 -64,6 <0,001
The Migraine Disability Assessment (MIDAS) is a questionnaire which measures
headache-related disability during the previous 90 days.
The MIDAS questionnaire was completed at baseline and 12 weeks after the system
was implanted.
The reduction in disability of 44.1 days between the groups is statistically significant
(p<0.001).
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.
Results: Pain Relief & Patient Satisfaction
12-Week Control Phase
The differences reported between the Active and Control Groups for both
measures were statistically significant (p<0,001).
17,2%
42,1%
0%
20%
40%
60%
80%
100%
Percentage of Pain Relief Since
Surgery
Control Group (n=52) Active Group (n=105)
19,2%
51,4%
0%
20%
40%
60%
80%
100%
Percentage of Patients Satisfied
With Headache Relief
Control Group (n=52) Active Group (n=105)
Active group participants reported (on average) 42,1% pain relief and 51,4% of them
were satisfied with their level of pain relief.
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.
Results: Quality of Life & Patient Assessment -
Open Label Phase

64,3%
30,0%
5,7%
68,4%
26,3%
5,3%
0%
20%
40%
60%
80%
100%
Improved Stayed the Same Deteriorated
Overall Quality of Life
Week 24 (N=140) Week 52 (N=133)
23%
n=32
44%
n=60
14%
n=19
15%
n=21
4%
n=6

Very Satisfied
Satisfied
Unsatisfied
Very Unsatisfied
Unable to Determine
Were you satisfied with the results of your
procedure? (N=138)
At the conclusion of the study 68.4% pts reported improved QOL, and 67% were
either satisfied or very satisfied w/ the results of the therapy.
2011 St. Jude Medical Neuromodulation Division. All rights reserved.
Migraine StudyKey Results Summary
12-Week Measures Active Control (Blind) p-value
Reduction in Headache Days
(Patient Diary)
36% reduction 25% reduction p=0.02
Reduction in Headache Days
(MIDAS)
28% reduction 4% reduction <0,001
Migraine Disability Assessment
(MIDAS)
41% reduction 13% reduction <0,001
Headache relief on 5-point
scale
53% excellent, good 17% excellent, good <0,001
Improvement in QOL 67% improved 17% improved <0,001
Satisfaction with Headache
Relief
51% satisfied 19% improved <0,001