Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Threshold Tracking Nerve Conduction Studies — DIAGNOSTIC_TEST
  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.

Study Details

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.

Key Dates

Start date

Jan 31, 2026

Status verified

Apr 2026

Primary completion

Aug 30, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy
  30 participants with no baseline neuropathy symptoms will be enrolled prior to starting cisplatin-based chemotherapy and will complete the following: * Baseline visit with neurological exams and conduction studies * Standard of care chemotherapy infusion (duration may vary depending on the chemotherapy regimen received) * Post-Infusion study visits via phone call (number of visits may vary depending on the chemotherapy regimen received) * In-clinic visit with neurological exams and conduction studies if participants develop cis-PN symptoms --If participants do not develop cis-PN symptoms, participants will be reevaluated 1 month post end of cisplatin treatment * 7-day end of treatment visit via phone call * 1-month post-treatment visit with neurological exams and conduction studies
• Experimental: Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy
  30 participants with cis-PN symptoms will be enrolled and will complete the following: -One-time visit with neurological exams and conduction studies

Primary Outcome Measure

Presence of change in Nerve Excitability in comparison to baseline nerve excitability. [ Time Frame: 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. ]

Central Contacts

• Ka-Wai Ho, MD
  617-667-1665
  [email protected]

Locations (2)

Find similar trials in Boston, MA

Related Studies

• MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine
  Recruiting · Brigham and Women's Hospital · Boston, Massachusetts
• Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer
  Recruiting · National Cancer Institute (NCI) · Boston, Massachusetts
• Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)
  Recruiting · Dana-Farber Cancer Institute · Boston, Massachusetts
• Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)
  Recruiting · Jaeb Center for Health Research · Birmingham, Alabama