Trial Outcomes & Findings for A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral Neuropathy (NCT NCT02349646)

Last Updated: 2019-10-16

Results Overview

The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).

Recruitment status

TERMINATED

Target enrollment

33 participants

Primary outcome timeframe

Baseline, 3, 6 and 12-Month Visits

Results posted on

2019-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Axium DRG Neurostimulator All subects implanted with intent to treat with the Axium DRG Neurostimulator
Overall Study STARTED	33
Overall Study Received Trial System	24
Overall Study Receive Permanent System	27
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=33 Participants All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Region of Enrollment Germany	33 participants n=5 Participants
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	16 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	0 Participants n=5 Participants
Race (NIH/OMB) White	33 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

PRIMARY outcome

Timeframe: Baseline, 3, 6 and 12-Month Visits

Population: Differences in participants over time is due to early withdrawals and missing data

Outcome measures

Outcome measures
Measure	Subjected Treated With the Permanent Implantable Axium System n=33 Participants All subjects treated with the Axium implantable neurostimulator
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline Baseline	7.4 units on a scale Standard Deviation 1.7
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 3-Month Visit	4.0 units on a scale Standard Deviation 2.6
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 6-Month Visit	3.4 units on a scale Standard Deviation 2.5
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 12-Month Visit	3.8 units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: 3, 6 and 12-Month Visits

Population: Differences in participants over time is due to early withdrawals and missing data

Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).

Outcome measures

Outcome measures
Measure	Subjected Treated With the Permanent Implantable Axium System n=23 Participants All subjects treated with the Axium implantable neurostimulator
Percentage of Subjects With at Least 50% Pain Reduction 12-Month Visit	8 Participants
Percentage of Subjects With at Least 50% Pain Reduction 3-Month Visit	13 Participants
Percentage of Subjects With at Least 50% Pain Reduction 6-Month Visit	14 Participants

Adverse Events

All Enrolled Subjects

Serious events: 8 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Subjects n=33 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Product Issues IPG Pocket Pain due to IPG displacement to ventral	3.0% 1/33 • Number of events 1
Product Issues Loss of Stimulation	3.0% 1/33 • Number of events 1
Nervous system disorders Conus cauda syndrome	3.0% 1/33 • Number of events 1
Injury, poisoning and procedural complications CSF leak	3.0% 1/33 • Number of events 1
Infections and infestations Infection at IPG site	3.0% 1/33 • Number of events 1
Vascular disorders Leriche's syndrome	3.0% 1/33 • Number of events 1
Injury, poisoning and procedural complications Loss of bladder control, sensational numbness, coordination problem right arm	3.0% 1/33 • Number of events 1
Injury, poisoning and procedural complications Nausea and headache	3.0% 1/33 • Number of events 1
Psychiatric disorders Suicide Attempt	3.0% 1/33 • Number of events 1

Other adverse events

Other adverse events
Measure	All Enrolled Subjects n=33 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Product Issues Loss of Stimulation	9.1% 3/33 • Number of events 3
Vascular disorders Hematoma	3.0% 1/33 • Number of events 1
Product Issues Overstimulation	3.0% 1/33 • Number of events 1
Injury, poisoning and procedural complications Wound dehiscence	3.0% 1/33 • Number of events 1

Additional Information

Jennifer Duggan

St. Jude Medical

Phone: +32(0)27746827

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60