Trial Outcomes & Findings for Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain (NCT NCT01094301)
NCT ID: NCT01094301
Last Updated: 2018-09-12
Results Overview
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Results posted on
2018-09-12
Participant Flow
Recruitment began in April 2010 and was concluded in March 2016. Subjects were screened for the study from the available pool of candidates who presented to the Investigators with shoulder pain following stroke.
In the original study design, subjects who completed the trial stage and were a success were enrolled in the fully implantable phase. In the revised study design, subjects were required to be both a trial stage success and have a return of pain to be enrolled into the fully implantable phase.
Participant milestones
| Measure |
Enrolled Subjects
This group includes subjects that were consented, met eligibility criteria, and received Leads.
|
|---|---|
|
Trial Stage
STARTED
|
28
|
|
Trial Stage
Subjects Who Received Smartpatch Lead
|
28
|
|
Trial Stage
COMPLETED
|
27
|
|
Trial Stage
NOT COMPLETED
|
1
|
|
Implant Stage
STARTED
|
13
|
|
Implant Stage
Met Criteria for Implant Stage
|
7
|
|
Implant Stage
Subjects Who Received SPR IPG
|
5
|
|
Implant Stage
COMPLETED
|
5
|
|
Implant Stage
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Enrolled Subjects
This group includes subjects that were consented, met eligibility criteria, and received Leads.
|
|---|---|
|
Trial Stage
Withdrawal by Subject
|
1
|
|
Implant Stage
Adverse Event
|
1
|
|
Implant Stage
Protocol Violation
|
1
|
|
Implant Stage
Withdrawal by Subject
|
2
|
|
Implant Stage
No return of pain
|
4
|
Baseline Characteristics
Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain
Baseline characteristics by cohort
| Measure |
Enrolled Subjects
n=28 Participants
This group includes subjects that were consented, met eligibility criteria, and received Leads.
|
|---|---|
|
Age, Continuous
|
56.2 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Type of Stroke
Hemorrhagic only
|
1 Participants
n=5 Participants
|
|
Type of Stroke
Hemorrhagic and Intracerebral hemorrhage (ICH)
|
3 Participants
n=5 Participants
|
|
Type of Stroke
Intracerebral hemorrhage
|
2 Participants
n=5 Participants
|
|
Type of Stroke
Subarachnoid hemorrhage
|
1 Participants
n=5 Participants
|
|
Type of Stroke
Ischemic only
|
20 Participants
n=5 Participants
|
|
Type of Stroke
Ischemic and Intracerebral hemorrhage (ICH)
|
1 Participants
n=5 Participants
|
|
Stroke Onset to Enrollment
|
2.7 Years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)Population: One subject did not reach end of treatment. Due to this, the subject was not included in the end of treatment analysis.
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Outcome measures
| Measure |
Trial Stage Subjects
n=28 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Pain Intensity (Trial Stage)
EOT BPI3 Score
|
5.0 score on a scale
Standard Deviation 2.5
|
|
Pain Intensity (Trial Stage)
Placebo Effect
|
2.1 score on a scale
Standard Deviation 1.9
|
|
Pain Intensity (Trial Stage)
Treatment Effect
|
1.0 score on a scale
Standard Deviation 2.2
|
|
Pain Intensity (Trial Stage)
Baseline BPI3 Score
|
8.2 score on a scale
Standard Deviation 1.4
|
|
Pain Intensity (Trial Stage)
End of Placebo BPI3 Score
|
6.1 score on a scale
Standard Deviation 1.8
|
|
Pain Intensity (Trial Stage)
Reduction at EOT Compared to Baseline
|
3.1 score on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage)Population: 13 subjects were a trial stage success, 7 of which meet the eligibility criteria for the implant stage, and 5 of the subjects continued on to have the SPR IPG implanted.
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON.
Outcome measures
| Measure |
Trial Stage Subjects
n=5 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Pain Intensity (Implant Stage)
12-months post IPG stim-on
|
0.8 score on a scale
Standard Deviation 1.3
|
|
Pain Intensity (Implant Stage)
24-months post IPG stim-on
|
1.6 score on a scale
Standard Deviation 3.0
|
|
Pain Intensity (Implant Stage)
3-weeks post IPG stim-on
|
2.0 score on a scale
Standard Deviation 1.3
|
|
Pain Intensity (Implant Stage)
6-weeks post IPG stim-on
|
0.3 score on a scale
Standard Deviation 0.8
|
|
Pain Intensity (Implant Stage)
12-weeks post IPG stim-on
|
0.4 score on a scale
Standard Deviation 0.9
|
|
Pain Intensity (Implant Stage)
6-months post IPG stim-on
|
1.6 score on a scale
Standard Deviation 1.8
|
|
Pain Intensity (Implant Stage)
9-months post IPG stim-on
|
0.6 score on a scale
Standard Deviation 1.3
|
|
Pain Intensity (Implant Stage)
36-months post IPG stim-on
|
1.2 score on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Total of 86 months (from when the first subjects enrolled to when the last subject completed the study)At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
Outcome measures
| Measure |
Trial Stage Subjects
n=28 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Device-Related Adverse Events
Subjects who reported device related AEs
|
20 Participants
|
|
Device-Related Adverse Events
Subjects who did not report any device related AEs
|
8 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (EOT)Population: Twenty-seven subjects completed the study through end of treatment (EOT)
The number of subjects who were a trial stage success is presented. Trial Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at the end of t.he Trial Stage beyond any placebo effect.
Outcome measures
| Measure |
Trial Stage Subjects
n=27 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Number of Subjects Who Were a Trial Stage Success
|
13 Participants
|
PRIMARY outcome
Timeframe: 12-weeks post IPG-Stim ONNumber of subjects who were an Implant Stage Success is presented. Implant Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at 12-week post IPG stimulation ON beyond any placebo effect.
Outcome measures
| Measure |
Trial Stage Subjects
n=5 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Number of Subjects Who Were an Implant Stage Success
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)Population: One subject did not reach end of treatment and was not included in the end of treatment analysis.
Subjects were asked to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life on an 11-point numerical rating scale where 0 represents "does not interfere" and 10 represents "completely interferes." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Outcome measures
| Measure |
Trial Stage Subjects
n=28 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Pain Interference (Trial Stage)
End of Placebo BPI9 Score
|
4.7 score on a scale
Standard Deviation 2.3
|
|
Pain Interference (Trial Stage)
EOT BPI9 Score
|
3.2 score on a scale
Standard Deviation 3.0
|
|
Pain Interference (Trial Stage)
Baseline BPI9 Score
|
6.2 score on a scale
Standard Deviation 2.5
|
|
Pain Interference (Trial Stage)
BPI9 Reduction at EOT Compared to End of Placebo
|
1.3 score on a scale
Standard Deviation 2.1
|
|
Pain Interference (Trial Stage)
BPI9 Reduction at EOT Compared to Baseline
|
2.9 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, 3-week (Trial Stage), 6-week (Trial Stage);Population: One subject did not reach end of treatment and was not included in the end of treatment analysis.
Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Outcome measures
| Measure |
Trial Stage Subjects
n=28 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Pain-Free Passive Range of Motion (Trial Stage)
Baseline ROM
|
89.8 Degrees
Standard Deviation 53.1
|
|
Pain-Free Passive Range of Motion (Trial Stage)
End of Placebo ROM
|
102.8 Degrees
Standard Deviation 49.0
|
|
Pain-Free Passive Range of Motion (Trial Stage)
EOT ROM
|
119.5 Degrees
Standard Deviation 38.6
|
|
Pain-Free Passive Range of Motion (Trial Stage)
Increase in ROM at EOT Compared to End of Placebo
|
17.5 Degrees
Standard Deviation 41.3
|
|
Pain-Free Passive Range of Motion (Trial Stage)
Increase in ROM at EOT Compared to Baseline
|
31.2 Degrees
Standard Deviation 51.7
|
SECONDARY outcome
Timeframe: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)Population: Computer analysis of the available data was not completed for four subjects at baseline, six subjects at 3-weeks, and eight subjects at end of treatment. Additionally, one subject did not reach end of treatment and was not included in the end of treatment analysis.
Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for Baseline, 3-week (End of Placebo), and 6-week (End of Treatment) were reported.
Outcome measures
| Measure |
Trial Stage Subjects
n=24 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Quality of Life (Trial Stage)
Bodily Pain; 6-week (Trial Stage)
|
39.4 Scores on a scale
Standard Deviation 7.0
|
|
Quality of Life (Trial Stage)
General Health; 3-week (Trial Stage)
|
39.9 Scores on a scale
Standard Deviation 8.6
|
|
Quality of Life (Trial Stage)
Bodily Pain; Baseline
|
32.2 Scores on a scale
Standard Deviation 5.7
|
|
Quality of Life (Trial Stage)
Bodily Pain; 3-week (Trial Stage)
|
36.2 Scores on a scale
Standard Deviation 6.3
|
|
Quality of Life (Trial Stage)
Bodily Pain; Change from End of Sham to EOT
|
3.4 Scores on a scale
Standard Deviation 5.7
|
|
Quality of Life (Trial Stage)
Role-physical; Baseline
|
29.8 Scores on a scale
Standard Deviation 8.4
|
|
Quality of Life (Trial Stage)
Role-physical; 3-week (Trial Stage)
|
30.7 Scores on a scale
Standard Deviation 10.3
|
|
Quality of Life (Trial Stage)
Role-physical; 6-week (Trial Stage)
|
33.6 Scores on a scale
Standard Deviation 9.1
|
|
Quality of Life (Trial Stage)
Role-physical; Change from End of Sham to EOT
|
2.9 Scores on a scale
Standard Deviation 5.6
|
|
Quality of Life (Trial Stage)
Role-emotional; Baseline
|
35.7 Scores on a scale
Standard Deviation 14.6
|
|
Quality of Life (Trial Stage)
Role-emotional; 3-week (Trial Stage)
|
34.2 Scores on a scale
Standard Deviation 15.7
|
|
Quality of Life (Trial Stage)
Role-emotional; 6-week (Trial Stage)
|
38.6 Scores on a scale
Standard Deviation 13.6
|
|
Quality of Life (Trial Stage)
Role-emotional; Change from End of Sham to EOT
|
3.0 Scores on a scale
Standard Deviation 9.8
|
|
Quality of Life (Trial Stage)
Mental health; Baseline
|
43.1 Scores on a scale
Standard Deviation 11.5
|
|
Quality of Life (Trial Stage)
Mental health; 3-week (Trial Stage)
|
44.8 Scores on a scale
Standard Deviation 11.7
|
|
Quality of Life (Trial Stage)
Mental health; 6-week (Trial Stage)
|
48.5 Scores on a scale
Standard Deviation 9.4
|
|
Quality of Life (Trial Stage)
Mental health; Change from End of Sham to EOT
|
3.5 Scores on a scale
Standard Deviation 7.6
|
|
Quality of Life (Trial Stage)
Physical functioning; Baseline
|
27.3 Scores on a scale
Standard Deviation 9.6
|
|
Quality of Life (Trial Stage)
Physical functioning; 3-week (Trial)
|
27.3 Scores on a scale
Standard Deviation 11.2
|
|
Quality of Life (Trial Stage)
Physical functioning; 6-week (Trial Stage)
|
29.6 Scores on a scale
Standard Deviation 11.2
|
|
Quality of Life (Trial Stage)
Physical functioning; Change from EOS to EOT
|
2.5 Scores on a scale
Standard Deviation 5.3
|
|
Quality of Life (Trial Stage)
Social functioning; Baseline
|
39.6 Scores on a scale
Standard Deviation 12.5
|
|
Quality of Life (Trial Stage)
Social functioning; 3-week (Trial Stage)
|
39.3 Scores on a scale
Standard Deviation 12.9
|
|
Quality of Life (Trial Stage)
Social functioning; 6-week (Trial Stage)
|
43.9 Scores on a scale
Standard Deviation 10.2
|
|
Quality of Life (Trial Stage)
Social functioning; Change from End of Sham to EOT
|
3.1 Scores on a scale
Standard Deviation 8.8
|
|
Quality of Life (Trial Stage)
Vitality; Baseline
|
45.5 Scores on a scale
Standard Deviation 7.2
|
|
Quality of Life (Trial Stage)
Vitality; 3-week (Trial Stage)
|
45.4 Scores on a scale
Standard Deviation 8.0
|
|
Quality of Life (Trial Stage)
Vitality; 6-week (Trial Stage)
|
48.0 Scores on a scale
Standard Deviation 8.6
|
|
Quality of Life (Trial Stage)
Vitality; Change from End of Sham to EOT
|
1.9 Scores on a scale
Standard Deviation 6.6
|
|
Quality of Life (Trial Stage)
General Health; Baseline
|
42.4 Scores on a scale
Standard Deviation 11.0
|
|
Quality of Life (Trial Stage)
General Health; 6-week (Trial Stage)
|
41.1 Scores on a scale
Standard Deviation 9.0
|
|
Quality of Life (Trial Stage)
General Health; Change from End of Sham to EOT
|
1.0 Scores on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: BaselineSubjects were asked to document pain medication, doctor visits, supplies, related treatments, need for caregivers, time spent in skilled nursing facilities, and lost work due to their shoulder pain. This data was collected from subjects at Baseline and asked to recall this data for the 6-months prior to study enrollment. National average costs were not available for these data points, and therefore the overall economic impact of shoulder pain could not be reported.
Outcome measures
| Measure |
Trial Stage Subjects
n=28 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Number of Participants Completing the Economic Impact Survey
Subjects who completed economic impact survey
|
25 Participants
|
|
Number of Participants Completing the Economic Impact Survey
Subjects not completing economic impact survey
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)Population: One subject did not reach end of treatment and was not included in the end of treatment analysis.
Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Outcome measures
| Measure |
Trial Stage Subjects
n=28 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Emotional Functioning (Trial Stage)
Baseline BDI-II Score
|
13.4 Scores on a scale
Standard Deviation 8.8
|
|
Emotional Functioning (Trial Stage)
End of Placebo BDI-II Score
|
14.8 Scores on a scale
Standard Deviation 10.0
|
|
Emotional Functioning (Trial Stage)
EOT BDI-II Score
|
12.9 Scores on a scale
Standard Deviation 9.9
|
|
Emotional Functioning (Trial Stage)
BDI-II Reduction at EOT Compared to End of Placebo
|
1.6 Scores on a scale
Standard Deviation 6.9
|
|
Emotional Functioning (Trial Stage)
BDI-II Reduction at EOT Compared to Baseline
|
0 Scores on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 6-week (Trial Stage)Population: This survey was not a part of the original study design. It was administered to 21 subjects. Additionally, one subject did not answer the questions related to their study experience.
Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the Smartpatch Stimulation System as a method for managing post-stroke shoulder pain.
Outcome measures
| Measure |
Trial Stage Subjects
n=20 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
User Satisfaction (Trial Stage)
Reported study had positive impact on their life
|
18 Participants
|
|
User Satisfaction (Trial Stage)
Reported being satisfied with experience in study
|
19 Participants
|
|
User Satisfaction (Trial Stage)
Would recommend participation in study to a friend
|
20 Participants
|
SECONDARY outcome
Timeframe: 3-week (Trial Stage), 6-week (Trial Stage)Population: One subject did not reach end of treatment and was not included in the 6-week treatment analysis.
The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved". The subjects combine all the components of their experience into one overall score.
Outcome measures
| Measure |
Trial Stage Subjects
n=28 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Global Impact of Stimulation Therapy (Trial Stage)
3-week (Trial Stage) · Much improved
|
4 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
3-week (Trial Stage) · Very much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
3-week (Trial Stage) · Much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
3-week (Trial Stage) · Minimally worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
3-week (Trial Stage) · No Change
|
5 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
3-week (Trial Stage) · Minimally improved
|
17 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
3-week (Trial Stage) · Very much improved
|
2 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
6-week (Trial Stage) · Very much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
6-week (Trial Stage) · Much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
6-week (Trial Stage) · Minimally worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
6-week (Trial Stage) · No Change
|
3 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
6-week (Trial Stage) · Minimally improved
|
10 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
6-week (Trial Stage) · Much improved
|
13 Participants
|
|
Global Impact of Stimulation Therapy (Trial Stage)
6-week (Trial Stage) · Very much improved
|
1 Participants
|
SECONDARY outcome
Timeframe: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months, post IPG-Stim ON were reported.
Outcome measures
| Measure |
Trial Stage Subjects
n=5 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Quality of Life (Implant Stage)
Bodily pain; 3-weeks (Implant)
|
42.6 Scores on a scale
Standard Deviation 5.0
|
|
Quality of Life (Implant Stage)
Bodily pain; 12-weeks (Implant Stage)
|
46.7 Scores on a scale
Standard Deviation 10.5
|
|
Quality of Life (Implant Stage)
Bodily pain; 6-months (Implant Stage)
|
45.1 Scores on a scale
Standard Deviation 4.6
|
|
Quality of Life (Implant Stage)
Bodily pain; 9-months (Implant Stage)
|
43.7 Scores on a scale
Standard Deviation 11.5
|
|
Quality of Life (Implant Stage)
Bodily pain; 12-months (Implant Stage)
|
50.1 Scores on a scale
Standard Deviation 7.8
|
|
Quality of Life (Implant Stage)
Role-physical; 3-weeks (Implant Stage)
|
38.3 Scores on a scale
Standard Deviation 9.5
|
|
Quality of Life (Implant Stage)
Role-physical; 12-weeks (Implant Stage)
|
35.1 Scores on a scale
Standard Deviation 10.7
|
|
Quality of Life (Implant Stage)
Role-physical; 6-months (Implant Stage
|
40.4 Scores on a scale
Standard Deviation 6.6
|
|
Quality of Life (Implant Stage)
Role-physical; 9-months (Implant Stage
|
37.1 Scores on a scale
Standard Deviation 14.4
|
|
Quality of Life (Implant Stage)
Role-physical; 12-months (Implant Stage
|
37.5 Scores on a scale
Standard Deviation 10.0
|
|
Quality of Life (Implant Stage)
Role-emotional; 3-weeks (Implant Stage)
|
47.4 Scores on a scale
Standard Deviation 7.8
|
|
Quality of Life (Implant Stage)
Role-emotional; 12-weeks (Implant Stage)
|
38.3 Scores on a scale
Standard Deviation 15.7
|
|
Quality of Life (Implant Stage)
Role-emotional; 6-months (Implant Stage)
|
47.4 Scores on a scale
Standard Deviation 13.2
|
|
Quality of Life (Implant Stage)
Role-emotional; 9-months (Implant Stage)
|
39.8 Scores on a scale
Standard Deviation 13.2
|
|
Quality of Life (Implant Stage)
Role-emotional; 12-months (Implant Stage)
|
43.6 Scores on a scale
Standard Deviation 15.5
|
|
Quality of Life (Implant Stage)
Mental health; 3-weeks (Implant Stage)
|
52.4 Scores on a scale
Standard Deviation 5.2
|
|
Quality of Life (Implant Stage)
Mental health; 12-weeks (Implant Stage)
|
49.0 Scores on a scale
Standard Deviation 7.7
|
|
Quality of Life (Implant Stage)
Mental health; 6-months (Implant Stage)
|
50.7 Scores on a scale
Standard Deviation 9.1
|
|
Quality of Life (Implant Stage)
Mental health; 9-months (Implant Stage)
|
46.8 Scores on a scale
Standard Deviation 10.9
|
|
Quality of Life (Implant Stage)
Mental health; 12-months (Implant Stage)
|
47.9 Scores on a scale
Standard Deviation 12.8
|
|
Quality of Life (Implant Stage)
Physical functioning; 3-weeks (Implant Stage)
|
32.1 Scores on a scale
Standard Deviation 15.1
|
|
Quality of Life (Implant Stage)
Physical functioning; 12-weeks (Implant Stage)
|
31.3 Scores on a scale
Standard Deviation 13.0
|
|
Quality of Life (Implant Stage)
Physical functioning; 6-months (Implant Stage)
|
31.3 Scores on a scale
Standard Deviation 13.2
|
|
Quality of Life (Implant Stage)
Physical functioning; 9-months (Implant Stage)
|
32.1 Scores on a scale
Standard Deviation 13.8
|
|
Quality of Life (Implant Stage)
Physical functioning; 12-months (Implant Stage)
|
24.8 Scores on a scale
Standard Deviation 19.5
|
|
Quality of Life (Implant Stage)
Social functioning; 3-weeks (Implant Stage)
|
43.5 Scores on a scale
Standard Deviation 2.9
|
|
Quality of Life (Implant Stage)
Social functioning; 12-weeks (Implant Stage)
|
46.7 Scores on a scale
Standard Deviation 5.9
|
|
Quality of Life (Implant Stage)
Social functioning; 6-months (Implant Stage)
|
47.8 Scores on a scale
Standard Deviation 8.2
|
|
Quality of Life (Implant Stage)
Social functioning; 9-months (Implant Stage)
|
45.6 Scores on a scale
Standard Deviation 10.8
|
|
Quality of Life (Implant Stage)
Social functioning; 12-months (Implant Stage)
|
44.6 Scores on a scale
Standard Deviation 12.3
|
|
Quality of Life (Implant Stage)
Vitality; 3-weeks (Implant Stage)
|
48.4 Scores on a scale
Standard Deviation 2.5
|
|
Quality of Life (Implant Stage)
Vitality; 12-weeks (Implant Stage)
|
49.6 Scores on a scale
Standard Deviation 5.4
|
|
Quality of Life (Implant Stage)
Vitality; 6-months (Implant Stage)
|
51.4 Scores on a scale
Standard Deviation 5.4
|
|
Quality of Life (Implant Stage)
Vitality; 9-months (Implant Stage)
|
49.6 Scores on a scale
Standard Deviation 13.3
|
|
Quality of Life (Implant Stage)
Vitality; 12-months (Implant Stage)
|
50.2 Scores on a scale
Standard Deviation 9.6
|
|
Quality of Life (Implant Stage)
General health; 3-weeks (Implant Stage)
|
39.7 Scores on a scale
Standard Deviation 7.2
|
|
Quality of Life (Implant Stage)
General health; 12-weeks (Implant Stage)
|
40.1 Scores on a scale
Standard Deviation 8.0
|
|
Quality of Life (Implant Stage)
General health; 6-months (Implant Stage)
|
41.7 Scores on a scale
Standard Deviation 8.2
|
|
Quality of Life (Implant Stage)
General health; 9-months (Implant Stage)
|
41.3 Scores on a scale
Standard Deviation 11.6
|
|
Quality of Life (Implant Stage)
General health; 12-months (Implant Stage)
|
38.0 Scores on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)Subjects were asked to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life on an 11-point numerical rating scale where 0 represents "does not interfere" and 10 represents "completely interferes." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim On.
Outcome measures
| Measure |
Trial Stage Subjects
n=5 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Pain Interference (Implant Stage)
12-weeks post IPG stim-on
|
0.2 score on a scale
Standard Deviation 0.4
|
|
Pain Interference (Implant Stage)
3-weeks post IPG stim-on
|
0.5 score on a scale
Standard Deviation 0.4
|
|
Pain Interference (Implant Stage)
6-weeks post IPG stim-on
|
0.1 score on a scale
Standard Deviation 0.2
|
|
Pain Interference (Implant Stage)
6-months post IPG stim-on
|
0.3 score on a scale
Standard Deviation 0.5
|
|
Pain Interference (Implant Stage)
9-months post IPG stim-on
|
0.1 score on a scale
Standard Deviation 0.2
|
|
Pain Interference (Implant Stage)
12-months post IPG stim-on
|
0.1 score on a scale
Standard Deviation 0.3
|
|
Pain Interference (Implant Stage)
24-months post IPG stim-on
|
0.4 score on a scale
Standard Deviation 0.8
|
|
Pain Interference (Implant Stage)
36-months post IPG stim-on
|
0.0 score on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.
Outcome measures
| Measure |
Trial Stage Subjects
n=5 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Pain-Free Passive Range of Motion (Implant Stage)
3-weeks post IPG stim-on
|
125.2 Degrees
Standard Deviation 25.7
|
|
Pain-Free Passive Range of Motion (Implant Stage)
12-weeks post IPG stim-on
|
119.8 Degrees
Standard Deviation 11.6
|
|
Pain-Free Passive Range of Motion (Implant Stage)
6-months post IPG stim-on
|
141.2 Degrees
Standard Deviation 17.5
|
|
Pain-Free Passive Range of Motion (Implant Stage)
9-months post IPG stim-on
|
146.6 Degrees
Standard Deviation 20.3
|
|
Pain-Free Passive Range of Motion (Implant Stage)
12-months post IPG stim-on
|
151.4 Degrees
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.
Outcome measures
| Measure |
Trial Stage Subjects
n=5 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Emotional Functioning (Implant Stage)
3-weeks post IPG stim-on
|
10.2 Scores on a scale
Standard Deviation 9.7
|
|
Emotional Functioning (Implant Stage)
12-weeks post IPG stim-on
|
8.4 Scores on a scale
Standard Deviation 7.7
|
|
Emotional Functioning (Implant Stage)
6-months post IPG stim-on
|
10.6 Scores on a scale
Standard Deviation 10.1
|
|
Emotional Functioning (Implant Stage)
9-months post IPG stim-on
|
12.4 Scores on a scale
Standard Deviation 12.6
|
|
Emotional Functioning (Implant Stage)
12-months post IPG stim-on
|
12.6 Scores on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage)The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved". The subjects combine all the components of their experience into one overall score.
Outcome measures
| Measure |
Trial Stage Subjects
n=5 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Global Impact of Stimulation Therapy (Implant Stage)
36-months (Implant Stage) · Much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
3-weeks (Implant Stage) · Very much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
3-weeks (Implant Stage) · Much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
3-weeks (Implant Stage) · Minimally worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
3-weeks (Implant Stage) · No change
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
3-weeks (Implant Stage) · Minimally improved
|
3 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
3-weeks (Implant Stage) · Much improved
|
1 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
3-weeks (Implant Stage) · Very much improved
|
1 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-weeks (Implant Stage) · Very much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-weeks (Implant Stage) · Much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-weeks (Implant Stage) · Minimally worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-weeks (Implant Stage) · No change
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-weeks (Implant Stage) · Minimally improved
|
1 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-weeks (Implant Stage) · Much improved
|
3 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-weeks (Implant Stage) · Very much improved
|
1 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
6-months (Implant Stage) · Very much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
6-months (Implant Stage) · Much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
6-months (Implant Stage) · Minimally worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
6-months (Implant Stage) · No change
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
6-months (Implant Stage) · Minimally improved
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
6-months (Implant Stage) · Much improved
|
4 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
6-months (Implant Stage) · Very much improved
|
1 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
9-months (Implant Stage) · Very much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
9-months (Implant Stage) · Much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
9-months (Implant Stage) · Minimally worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
9-months (Implant Stage) · No change
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
9-months (Implant Stage) · Minimally improved
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
9-months (Implant Stage) · Much improved
|
4 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
9-months (Implant Stage) · Very much improved
|
1 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-months (Implant Stage) · Very much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-months (Implant Stage) · Much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-months (Implant Stage) · Minimally worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-months (Implant Stage) · No change
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-months (Implant Stage) · Minimally improved
|
1 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-months (Implant Stage) · Much improved
|
3 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
12-months (Implant Stage) · Very much improved
|
1 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
24-months (Implant Stage) · Very much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
24-months (Implant Stage) · Much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
24-months (Implant Stage) · Minimally worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
24-months (Implant Stage) · No change
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
24-months (Implant Stage) · Minimally improved
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
24-months (Implant Stage) · Much improved
|
3 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
24-months (Implant Stage) · Very much improved
|
2 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
36-months (Implant Stage) · Very much worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
36-months (Implant Stage) · Minimally worse
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
36-months (Implant Stage) · No change
|
1 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
36-months (Implant Stage) · Minimally improved
|
0 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
36-months (Implant Stage) · Much improved
|
2 Participants
|
|
Global Impact of Stimulation Therapy (Implant Stage)
36-months (Implant Stage) · Very much improved
|
2 Participants
|
SECONDARY outcome
Timeframe: 12-weeks,12-months post IPG-Stim ON (Implant Stage)Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the IPG System as a method for managing post-stroke shoulder pain.
Outcome measures
| Measure |
Trial Stage Subjects
n=5 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
User Satisfaction (Implant Stage)
Satisfied with experience 12-weeks Implant Stage
|
5 Participants
|
|
User Satisfaction (Implant Stage)
Satisfied with experience 12-mths Implant Stage
|
5 Participants
|
|
User Satisfaction (Implant Stage)
Pleased with the SPR System 12-wks Implant Stage
|
5 Participants
|
|
User Satisfaction (Implant Stage)
Pleased with the SPR System 12-mths Implant Stage
|
5 Participants
|
|
User Satisfaction (Implant Stage)
Would recommend to a friend 12-wks Implant Stage
|
5 Participants
|
|
User Satisfaction (Implant Stage)
Would recommend to a friend 12-mths Implant Stage
|
5 Participants
|
|
User Satisfaction (Implant Stage)
Wanted to participate again 12-wks Implant Stage
|
5 Participants
|
|
User Satisfaction (Implant Stage)
Wanted to participate again 12-mnths Implant Stage
|
5 Participants
|
|
User Satisfaction (Implant Stage)
Positive impact on life 12-wks Implant Stage
|
5 Participants
|
|
User Satisfaction (Implant Stage)
Positive impact on life 12-mnths Implant Stage
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)Population: This survey was collected for the last 9 subjects enrolled in the Trial Stage due to a mid-study protocol change. Of these 9 subjects,6 subjects completed the survey at 3-weeks and 8 subjects completed the survey at 6-weeks.
Subjects were asked to assess their arm impairment using the Stroke Upper Limb Capacity Scale (SULCS) test. The SULCS is a validated upper limb capacity scale which includes tasks directly related to activities of daily living individuals experience in their home environment. The SULCS consists of 10 items, with each item having a possible score of 0 or 1: 3 items for arm capacity without active hand capacity; 4 items for arm capacity and basic hand capacity; and, 3 items for complex hand capacity. These scores were summed with a higher score indicating better capacity, with 10 being the max score. The average score across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Trial Stage).
Outcome measures
| Measure |
Trial Stage Subjects
n=9 Participants
Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
|
|---|---|
|
Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage)
6-weeks SULCS Score (Trial Stage)
|
3.3 Scores on a scale
Standard Deviation 3.4
|
|
Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage)
Baseline SULCS Score
|
3.8 Scores on a scale
Standard Deviation 3.7
|
|
Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage)
3-weeks SULCS Score (Trial Stage)
|
3.7 Scores on a scale
Standard Deviation 3.4
|
Adverse Events
Enrolled Subjects
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enrolled Subjects
n=28 participants at risk
This group includes subjects that were consented, met eligibility criteria, and received Leads.
|
|---|---|
|
Cardiac disorders
Complaints of Chest Pain
|
3.6%
1/28 • Number of events 2 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Cardiac disorders
Myocardial Infarction
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Cardiac disorders
Acute heart failure exacerbation
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Cardiac disorders
Syncope
|
10.7%
3/28 • Number of events 4 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Infections and infestations
Cellulitis
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Nervous system disorders
Seizure
|
7.1%
2/28 • Number of events 2 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
Other adverse events
| Measure |
Enrolled Subjects
n=28 participants at risk
This group includes subjects that were consented, met eligibility criteria, and received Leads.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation (redness, mild skin abrasion, or mild grade 1 pressure sore with intact skin)
|
39.3%
11/28 • Number of events 12 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Product Issues
Painful Stimulation
|
14.3%
4/28 • Number of events 7 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Skin and subcutaneous tissue disorders
Painful Keloid
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Skin and subcutaneous tissue disorders
Granuloma
|
17.9%
5/28 • Number of events 5 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Psychiatric disorders
Distress
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
5/28 • Number of events 5 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Skin and subcutaneous tissue disorders
Tenderness at lead exit site
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
General disorders
Fall
|
14.3%
4/28 • Number of events 5 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Nervous system disorders
Migraines
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Nervous system disorders
Nerve Pain
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
General disorders
Atypical sensation (Tingling/Quivering of fingers/hands or "shock-like" episode after lead removal)
|
10.7%
3/28 • Number of events 3 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
General disorders
Subconjunctival hematoma
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
General disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
General disorders
Malaise
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
General disorders
Total body aches
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Musculoskeletal and connective tissue disorders
Ipsilateral spasms of upper arm and shoulder
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Skin and subcutaneous tissue disorders
Report of redness on hand
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Musculoskeletal and connective tissue disorders
Elbow stiffness and appearance of fluid
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Skin and subcutaneous tissue disorders
Benign tumor index finger
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
|
Surgical and medical procedures
Release of achilles tendon
|
3.6%
1/28 • Number of events 1 • Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60