NCT07095998

Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

Evaluation of Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ka-Wai Ho · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Neuropathy Due to Chemotherapy
• Peripheral Neuropathy
• Neurotoxicity Syndromes
• Neuropathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Threshold Tracking Nerve Conduction Studies	Measurement of nerve excitability parameters, including response to sub-threshold pre-pulses and other stimuli. The DS5 0 Isolated Bipolar Constant Current Stimulator is a non-invasive, non-therapeutic device that provides controlled electrical stimuli for detailed function assessment of the superficial radial, superficial peroneal, ulnar, and sural nerves.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-30
• Completion: 2027-12-31
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

2 sites across 1 country: United States