This study aims to evaluate nerve excitability in participants with cisplatin-induced peripheral neuropathy (cis-PN) using threshold tracking nerve conduction studies (TTNCS). By assessing changes in nerve excitability parameters, the study seeks to enhance understanding of the pathophysiology of cis-PN and identify early markers of neurotoxicity in participants undergoing cisplatin-based chemotherapy.

This study aims to evaluate nerve excitability in participants with cisplatin-induced peripheral neuropathy (cis-PN) using threshold tracking nerve conduction studies (TTNCS). By assessing changes in nerve excitability parameters, the study seeks to enhance understanding of the pathophysiology of cis-PN and identify early markers of neurotoxicity in participants undergoing cisplatin-based chemotherapy.

Peripheral neuropathy is a sensory disorder where patients feel a burning, tingling, or pins-and-needles sensation in the hands and feet that can lead to oversensitivity or numbness.

The U.S. Food and Drug Administration (FDA) has not approved DS5 0 Isolated Bipolar Constant Current Stimulator as a diagnostic tool for Peripheral Neuropathy.

The research study procedures include screening for eligibility, in-clinic visits, blood tests, questionnaires, and standard neurological exams called nerve conduction studies and Threshold tracking nerve conduction studies.

Participants will be placed into one of the following groups:

• Cohort A: Participants without previous treatment with cisplatin and are about to start treatment with Cisplatin.
• Cohort B: Participants with previous treatment with cisplatin in the past 3 months (and no longer being treated with cisplatin) and are currently experiencing cisplatin- induced peripheral neuropathy.

It is expected that about 60 people will take part in this research study.

Inclusion Criteria Cohort A:

• Adults age ≥ 18 who will begin cisplatin-based chemotherapy either alone or in combination with other agents that are not known to cause neuropathy.
• Participants must have adequate hematologic parameters to allow chemotherapy.

Exclusion Criteria Cohort A:

• Pre-existing peripheral neuropathy;
• Family history of a genetic/familial neuropathy;
• Any contraindication for treatment with cisplatin as determined by their primary oncologist;
• Chemotherapy regimen combining cisplatin with another known chemotherapy agent that may cause peripheral neuropathy;
• Patients with cardiac or spinal stimulating devices;
• Women who are pregnant or breastfeeding;
• Adults with impaired consent capacity as patients must be able to fill out questionnaires regarding their neuropathy symptoms;
• Other medical conditions that in the opinion of the treating physician would make the protocol unreasonably hazardous for the patient;
• Patients not considered to be able to comply with the protocol.

Inclusion Criteria Cohort B:

• Adults age ≥ 18 with a diagnosis of cis-PN.
• The last dose of cisplatin must be ≥ 3 months prior to study enrollment. Patients who may have been previously enrolled in Cohort A of this study are eligible to participate in Cohort B if they continue to have cis-PN symptoms 3 months after completion of cisplatin therapy.

Exclusion Criteria Cohort B:

• Pre-existing peripheral neuropathy;
• Family history of a genetic/familiar neuropathy;
• History of cisplatin-based regimen combining cisplatin with another known chemotherapy agent that may cause peripheral neuropathy;
• Patients with cardiac or spinal stimulating devices;
• Women who are pregnant or breastfeeding;
• Adults with impaired consent capacity as patients must be able to fill out questionnaires regarding their neuropathy symptoms;
• Other medical conditions that in the opinion of the treating physician would make the protocol unreasonably hazardous for the patient;
• Patients not considered to be able to comply with the protocol.

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Data can be shared no earlier than 1 year following the date of publication

Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu