Peripheral Neuropathy Trial, Recruiting NCT05411523 Sponsor: Mayo Clinic Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT05411523
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older who have been diagnosed with nerve damage caused by chemotherapy (called CIPN) that has lasted more than six months after chemotherapy ended
  • People who have lower leg or foot pain rated at 5 or higher on a scale of 0–10
  • People who have already tried at least two medications for nerve pain without enough relief
  • People who have had nerve testing that shows a specific pattern of nerve damage in the legs
  • People who completed a trial (temporary) use of a 10-kHz spinal cord stimulator for CIPN and reported at least 75% reduction in pain during that trial
  • People whose nerve condition is currently stable and not getting worse
  • People who are on a consistent, unchanged pain medication routine
  • People who are considered medically suitable for the surgical procedures this study involves
  • People who can read and understand English questionnaires and sign a consent form in English
  • People who are willing and able to give informed consent
  • People who are willing and able to attend all required study visits and complete all study-related tasks

Who may not be able to join:

  • People who do not wish to take part in the study
  • People who have nerve damage in only one specific nerve in the lower leg (rather than a wider pattern of nerve damage)
  • People who have had a lower limb amputation or leg ulcers
  • People who have another painful condition unrelated to their chemotherapy-related nerve damage that is not being treated in this study
  • People with a Body Mass Index (BMI) of 40 or above (a measure of body weight relative to height)
  • People taking more than 120 mg of the medication omeprazole (confirm with trial site)
  • People with a progressive nerve or neurological disease, such as multiple sclerosis, certain inflammatory nerve conditions, brain or spinal cord tumours, or severe spinal narrowing, among others
  • People with certain serious health conditions, including bleeding or clotting disorders, or significantly reduced heart or lung function
  • People who are receiving or planning to receive another non-SCS procedure to treat their leg pain during the study
  • People who have active, spreading cancer or untreated localised cancer — only people whose cancer is considered to be in remission by their oncologist are eligible
  • People with a life expectancy of less than one year
  • People with untreated addiction or dependency on medications, alcohol, or illicit drugs
  • People with an active, disruptive, or unstable psychological or psychiatric condition

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Ryan S. D'Souza, MD, Mayo Clinic in Rochester

Phone: 855-776-0015

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
14 April 2022
Est. completion
15 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pain intensity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov