Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-02 @ 11:18 AM
Study NCT ID:
NCT05935956
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation for the Treatment of Chemotherapy Induced Neuropathy
Sponsor:
NeuraLace Medical, Inc.
Organization:
Study Overview
Official Title:
An Observational, Single Arm, Open Label Study Evaluating the Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation (mPNS) for the Treatment of Chemotherapy Induced Neuropathy (mPNS-CH)
Status:
COMPLETED
Status Verified Date:
2023-07
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:
mPNS-CH
Brief Summary:
Assess the safety and effectiveness of Axon Therapy in the treatment of chemotherapy-induced neuropathy
Detailed Description:
This is an observational, single arm, open label study in which up to 20 subjects diagnosed with chemotherapy induced neuropathy will be treated with mPNS.
Subjects will be consented, screened, and undergo a 7-day baseline assessment to measure pain scores and assess diary compliance. Subjects who meet inclusion criteria will undergo an in-clinic baseline evaluation and start their treatment.
All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days) and Day 90 (± 14 days) and will return to the clinic for mPNS treatments as follows:
* Month 1: 6 treatments
* WEEK 1: 3 treatments (consecutive treatments are best)
* WEEK 2-4: Weekly treatments
* Month 2: Bi-Weekly treatment
* Month 3: Treatments every 2-4 weeks
* Additional treatments to treat flare ups; defined as an episode of pain with a VAS of at least 5 following an increase in daily activities.
* The Lead Investigator is provided the discretion to modify the treatment protocol based on subject response.
In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through 90 days of the study. Subjects will receive weekly phone follow-up for diary reminders and to assess for the occurrence of adverse events after treatment starts. Weekly phone follow-ups will only occur during weeks when the subject is not seen in the clinic.
Subjects will be consented, screened, and undergo a 7-day baseline assessment to measure pain scores and assess diary compliance. Subjects who meet inclusion criteria will undergo an in-clinic baseline evaluation and start their treatment.
All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days) and Day 90 (± 14 days) and will return to the clinic for mPNS treatments as follows:
* Month 1: 6 treatments
* WEEK 1: 3 treatments (consecutive treatments are best)
* WEEK 2-4: Weekly treatments
* Month 2: Bi-Weekly treatment
* Month 3: Treatments every 2-4 weeks
* Additional treatments to treat flare ups; defined as an episode of pain with a VAS of at least 5 following an increase in daily activities.
* The Lead Investigator is provided the discretion to modify the treatment protocol based on subject response.
In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through 90 days of the study. Subjects will receive weekly phone follow-up for diary reminders and to assess for the occurrence of adverse events after treatment starts. Weekly phone follow-ups will only occur during weeks when the subject is not seen in the clinic.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: