Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290661
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-01
Brief Title:
Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Postherpetic Neuralgia
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Prospective Multicentre Randomised Withdrawal Design of a Clinical Trial Evaluating the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System for Patients With Postherpetic Neuralgia
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia The main questions it aims to answer are
1 The efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia
2 The safety of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co Ltd Then the subjects whose VAS scores decrease more 30 than baseline level are classified into two groups randomly One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group All subjects are required to make their own subjects pain diary to record VSA score before and after implantation until at the end of follow-up Also participants are asked to report use of analgesic medications number of awakenings and adverse events
Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with postherpetic neuralgia
1 The efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia
2 The safety of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co Ltd Then the subjects whose VAS scores decrease more 30 than baseline level are classified into two groups randomly One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group All subjects are required to make their own subjects pain diary to record VSA score before and after implantation until at the end of follow-up Also participants are asked to report use of analgesic medications number of awakenings and adverse events
Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with postherpetic neuralgia
Detailed Description:
The investigators divide study process into 3 main periods called enrollmentbaseline period treatment period and follow-up period The treatment period is classified into test period randomized withdrawal period and observation period further
1 Enrollmentbaseline period This study will be conducted at four clinical trial sites in China with 3 to 6 subjects included in the pretest and the formal trial planned to enroll 56 subjects All subjects enter screening process after signing the informed consent form ICF approved by the ethics committee Subjects are enrolled who meet inclusion criteria and do not meet any exclusion criteria Enrolled subjects will undergo vital signs physical examination laboratory tests and visual analogue scale VAS scores for pain for at least 4 days Neuropathic Pain Scale DN4 and the Short Form Health Survey SF-36 as part of the screening period assessment prior to electrode implantation
2 Treatment period 21 Implantation of devices Enrolled subjects are implanted with the percutaneous peripheral nerve stimulation system which was parameterized by the investigator via a programmable controller Subjects are provided with a Transcutaneous Peripheral Nerve Stimulation Remote Control Instruction Manual to guide them in the proper operation and use of the system
22 Test period Investigators will adjust stimulation parameters and record VAS score under different parameters conditions The enrolled subjects are provided 1 to 5 stimulation therapy patterns parameterized by investigators after the test
Then the subjects receive continuous stimulation with parameterized patterns of 7 3 days and VAS scores are be recorded every day of 7 days Subjects will enter next stage if their VAS scores decrease more than 30 from baseline level or withdraw the trial as reduction less than 30 and devices are removed
23 Randomized withdrawal period Subject will be classified into random group One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group Both of two groups are performed stimulation in the next 7 days The subjects of control group will get active stimulation again as the VAS scores back to and maintain 2 days at baseline level VAS scores will be recorded every day during this period
24 Observation period The devices are on work until 28th day after the implantation in trial group stimulators are turned on after randomized withdrawal period until 28th day after the implantation in control group
All subjects have electrode leads removed on day 28 of implantation or at early withdrawal
3 Follow-up period Investigators will begin follow up as the removal of electrode leads or on the day 28 of implantation Indicators including VAS score will be evaluated and recorded to assess the efficacy and safety of percutaneous peripheral nerve stimulation during follow-up
1 Enrollmentbaseline period This study will be conducted at four clinical trial sites in China with 3 to 6 subjects included in the pretest and the formal trial planned to enroll 56 subjects All subjects enter screening process after signing the informed consent form ICF approved by the ethics committee Subjects are enrolled who meet inclusion criteria and do not meet any exclusion criteria Enrolled subjects will undergo vital signs physical examination laboratory tests and visual analogue scale VAS scores for pain for at least 4 days Neuropathic Pain Scale DN4 and the Short Form Health Survey SF-36 as part of the screening period assessment prior to electrode implantation
2 Treatment period 21 Implantation of devices Enrolled subjects are implanted with the percutaneous peripheral nerve stimulation system which was parameterized by the investigator via a programmable controller Subjects are provided with a Transcutaneous Peripheral Nerve Stimulation Remote Control Instruction Manual to guide them in the proper operation and use of the system
22 Test period Investigators will adjust stimulation parameters and record VAS score under different parameters conditions The enrolled subjects are provided 1 to 5 stimulation therapy patterns parameterized by investigators after the test
Then the subjects receive continuous stimulation with parameterized patterns of 7 3 days and VAS scores are be recorded every day of 7 days Subjects will enter next stage if their VAS scores decrease more than 30 from baseline level or withdraw the trial as reduction less than 30 and devices are removed
23 Randomized withdrawal period Subject will be classified into random group One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group Both of two groups are performed stimulation in the next 7 days The subjects of control group will get active stimulation again as the VAS scores back to and maintain 2 days at baseline level VAS scores will be recorded every day during this period
24 Observation period The devices are on work until 28th day after the implantation in trial group stimulators are turned on after randomized withdrawal period until 28th day after the implantation in control group
All subjects have electrode leads removed on day 28 of implantation or at early withdrawal
3 Follow-up period Investigators will begin follow up as the removal of electrode leads or on the day 28 of implantation Indicators including VAS score will be evaluated and recorded to assess the efficacy and safety of percutaneous peripheral nerve stimulation during follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None