CompletedNot Applicable

Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation for the Treatment of Chemotherapy Induced Neuropathy

United States14 participantsStarted 2023-06-09

Plain-language summary

Assess the safety and effectiveness of Axon Therapy in the treatment of chemotherapy-induced neuropathy

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Evidence of a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.
✓. Subject is willing and able to comply with scheduled visits, treatment plan, daily pain, and other study procedures subject is able and willing to complete twice daily diary for 90 days.
✓. Subject must be literate in English to fill out the study questionnaires.
✓. Men or women of any race or ethnicity who are 18-85 years of age.
✓. Subject must have chemotherapy induced neuropathy for more than three months per medical history.
✓. Subject has a pain score \>5 on a VAS at Enrollment/Screening Visit.
✓. Subject has completed at least one of the two daily pain diary entries on at least three days between the Enrollment/Screening Visit and Visit 1 with a mean pain score of ≥4 and \<10 based on Daily VAS to be eligible for the study.
✓. Subject has been on a stable pain medication regimen for at least 28 days, as determined by the investigator or is not taking pain medications, at the baseline assessment in this study.

Exclusion criteria

✕. Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia, carpal or tarsal tunnel syndrome; subjects whose post-traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral.
✕. Subject has a currently diagnosed progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, or severe/critical spinal stenosis (stenosis).
✕. Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.
✕. Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
✕. Participation in any other clinical trial within 30 days prior to screening and/or during participation in this study.
✕. Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment.
✕. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality, or other factors that may increase the risk associated with study participation or investigational product administration or may interfere with compliance or the interpretation of study results and, in the judgment of the investigator would make the subject inappropriate to participate in the study.
✕. Subjects with pending Worker's Compensation, civil litigation, or disability claims; Subjects with fully resolved litigation and compensation claims can participate.

What they're measuring

Effectiveness of mPNS for treating chemotherapy-induced neuropathy, measured by a reduction in pain at Day 90 as compared to Baseline, using a visual analog scale (VAS).

Timeframe: 90 days

Safety of mPNS for the treatment of chemotherapy-induced neuropathy, as measured by the incidence of therapy-related adverse events (AEs) through Day 90.

Timeframe: 90 days

Trial details

NCT IDNCT05935956

SponsorNeuraLace Medical, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-21

View on ClinicalTrials.gov More Neuralgia trials

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Evidence of a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.
✓. Subject is willing and able to comply with scheduled visits, treatment plan, daily pain, and other study procedures subject is able and willing to complete twice daily diary for 90 days.
✓. Subject must be literate in English to fill out the study questionnaires.
✓. Men or women of any race or ethnicity who are 18-85 years of age.
✓. Subject must have chemotherapy induced neuropathy for more than three months per medical history.
✓. Subject has a pain score \>5 on a VAS at Enrollment/Screening Visit.
✓. Subject has completed at least one of the two daily pain diary entries on at least three days between the Enrollment/Screening Visit and Visit 1 with a mean pain score of ≥4 and \<10 based on Daily VAS to be eligible for the study.
✓. Subject has been on a stable pain medication regimen for at least 28 days, as determined by the investigator or is not taking pain medications, at the baseline assessment in this study.

Exclusion criteria

✕. Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia, carpal or tarsal tunnel syndrome; subjects whose post-traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral.
✕. Subject has a currently diagnosed progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, or severe/critical spinal stenosis (stenosis).
✕. Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.
✕. Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
✕. Participation in any other clinical trial within 30 days prior to screening and/or during participation in this study.
✕. Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment.
✕. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality, or other factors that may increase the risk associated with study participation or investigational product administration or may interfere with compliance or the interpretation of study results and, in the judgment of the investigator would make the subject inappropriate to participate in the study.
✕. Subjects with pending Worker's Compensation, civil litigation, or disability claims; Subjects with fully resolved litigation and compensation claims can participate.

What they're measuring

Effectiveness of mPNS for treating chemotherapy-induced neuropathy, measured by a reduction in pain at Day 90 as compared to Baseline, using a visual analog scale (VAS).

Timeframe: 90 days

Safety of mPNS for the treatment of chemotherapy-induced neuropathy, as measured by the incidence of therapy-related adverse events (AEs) through Day 90.

Timeframe: 90 days