Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

This study is looking at how cisplatin, a chemotherapy drug, affects your nerves. It uses a special test called Threshold Tracking Nerve Conduction Studies (TTNCS) to measure nerve excitability. This helps researchers understand why some people develop cisplatin-induced peripheral neuropathy (cis-PN), a condition causing burning or tingling in hands and feet. The study wants to find early signs of nerve damage. You can join if you are an adult starting cisplatin chemotherapy or if you have already had cisplatin and are experiencing cis-PN. The main goal is to see if there's a change in your nerve excitability compared to before treatment or at the time of the test. The study plans to enroll 60 participants.

Study design
This interventional study plans to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
You would have screening, in-clinic visits, blood tests, questionnaires, standard neurological exams, and Threshold Tracking Nerve Conduction Studies. For some, these are done at baseline and within 24 weeks of starting cisplatin.
Compensation
Not stated in the trial record.
Follow-up
For participants starting cisplatin, nerve excitability is measured at baseline and within 24 weeks of starting treatment. For others, it's during the TTNCS procedure.

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NCT07095998

Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

Recruiting
NAAges 18+InterventionalDiagnostic
Ka-Wai Ho
~60 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Threshold Tracking Nerve Conduction Studies

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of change in Nerve Excitability in comparison to baseline nerve excitability.
Measured over For Arm A, the time frame is at baseline and within 24 weeks of cisplatin initiation. For Arm B, the time frame is during the TTNCS procedure.
Peripheral Neuropathy Due to Chemotherapy
Peripheral Neuropathy
Neurotoxicity Syndromes
Neuropathy
2 sites across 1 states
Massachusetts2
  • Ka-Wai Ho, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center
  • Tamar Berger, MD PhD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

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Eligibility criteria

Inclusion

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.
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

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.
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.
  • Presence of change in Nerve Excitability in comparison to baseline nerve excitability.For Arm A, the time frame is at baseline and within 24 weeks of cisplatin initiation. For Arm B, the time frame is during the TTNCS procedure.

    Nerve excitability will be assessed via Threshold Tracking Nerve Conduction Study (TTNCS). Excitability parameters collected will include refractoriness, superexcitability, extent of threshold change in threshold electrotonus (hyperpolarizing 90-100ms). A composite excitability score is calculated to assess overall change in excitability parameters, all of which are weighted equally (Park, S.B., Lin, C.S.Y., Kiernan, M.C. Nerve Excitability Assessment in Chemotherapy-induced Neurotoxicity.J. Vis. Exp. (62), e3439, doi:10.3791/3439 (2012).