NCT02349646

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

Terminated Results posted Last updated 16 October 2019

What this trial tests

trial testing Implantation with the commercially available Axium neurostimulator in Peripheral Neuropathy in 33 participants. Terminated before completion.

Timeline

25 April 2013

Primary endpoint
24 October 2016

24 October 2016

Quick facts

Lead sponsor	Abbott Medical Devices
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	33
Start date	25 April 2013
Primary completion	24 October 2016
Estimated completion	24 October 2016
Sites	1 location across Germany

Drugs / interventions tested

• Implantation with the commercially available Axium neurostimulator

Conditions studied

• Peripheral Neuropathy — all drugs for Peripheral Neuropathy →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain Intensity for Overall Pain From Pre-treatment Baseline Primary · Baseline, 3, 6 and 12-Month Visits

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).

Baseline

Group	Value	95% CI
Subjected Treated With the Permanent Implantable Axium System	7.4	± 1.7

3-Month Visit

Group	Value	95% CI
Subjected Treated With the Permanent Implantable Axium System	4.0	± 2.6

6-Month Visit

Group	Value	95% CI
Subjected Treated With the Permanent Implantable Axium System	3.4	± 2.5

12-Month Visit

Group	Value	95% CI
Subjected Treated With the Permanent Implantable Axium System	3.8	± 2.5

Percentage of Subjects With at Least 50% Pain Reduction Primary · 3, 6 and 12-Month Visits

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).

3-Month Visit

Group	Value	95% CI
Subjected Treated With the Permanent Implantable Axium System	13

6-Month Visit

Group	Value	95% CI
Subjected Treated With the Permanent Implantable Axium System	14

12-Month Visit

Group	Value	95% CI
Subjected Treated With the Permanent Implantable Axium System	8

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Enrolled Subjects

Serious: 8/33 (24%)

Deaths: 0/33

Serious adverse events (9 terms)

Reaction	System	All Enrolled Subjects
IPG Pocket Pain due to IPG displacement to ventral	Product Issues	—
Loss of Stimulation	Product Issues	—
Conus cauda syndrome	Nervous system disorders	—
CSF leak	Injury, poisoning and procedural complications	—
Infection at IPG site	Infections and infestations	—
Leriche's syndrome	Vascular disorders	—
Loss of bladder control, sensational numbness, coordination problem right arm	Injury, poisoning and procedural complications	—
Nausea and headache	Injury, poisoning and procedural complications	—
Suicide Attempt	Psychiatric disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	All Enrolled Subjects
Loss of Stimulation	Product Issues	—
Hematoma	Vascular disorders	—
Overstimulation	Product Issues	—
Wound dehiscence	Injury, poisoning and procedural complications	—

Most-reported serious reactions: IPG Pocket Pain due to IPG displacement to ventral, Loss of Stimulation, Conus cauda syndrome, CSF leak, Infection at IPG site, Leriche's syndrome, Loss of bladder control, sensational numbness, coordination problem right arm, Nausea and headache.

Data from ClinicalTrials.gov NCT02349646 adverse events section.

Sponsor's own description

10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy

Publications & conference data

No peer-reviewed publications indexed yet for this trial.