Peripheral Neuropathy Due to ChemotherapyNCT07095998
Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy
A study testing Threshold Tracking Nerve Conduction Studies in people with Peripheral Neuropathy Due to Chemotherapy and Peripheral Neuropathy, run by Ka-Wai Ho at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy, Neurotoxicity Syndromes
- What is being tested?
- Threshold Tracking Nerve Conduction Studies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Ka-Wai Ho, MD, 617-667-1665, kho5@bidmc.harvard.edu
Ka-Wai Ho, MD
- Not yet recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Tamar Berger, MD, PhD, 617-632-6140, Tamar_berger@dfci.harvard.edu
Tamar Berger, MD, PhD
About this study
Official title: Evaluation of Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy
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.
Read the 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
- Being tested
- Threshold Tracking Nerve Conduction Studies
- Keywords
- Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy, Neurotoxicity Syndromes, Neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold Tracking Nerve Conduction StudiesDiagnostic test
Also called TTNC, TTNCS
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 group | Role | What they receive |
|---|---|---|
| Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy | Experimental | 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 Receives: Diagnostic Test: Threshold Tracking Nerve Conduction Studies |
| Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy | Experimental | 30 participants with cis-PN symptoms will be enrolled and will complete the following:
-One-time visit with neurological exams and conduction studies Receives: Diagnostic Test: Threshold Tracking Nerve Conduction Studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of change in Nerve Excitability in comparison to baseline nerve excitability.
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).
Measured: 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.
Secondary outcomes (1)
Number of participants who develop neuropathy symptoms as assessed by CTCAE v. 5.0.
The Wilcoxon signed rank test (two tailed) will be used to compared measurements at these time points.
Measured: For Arm A, peripheral neuropathy symptoms will be assessed at baseline and the time of the development of Cis-PN symptoms over the course of 24 weeks. For Arm B, symptoms will be assessed immediately before the TTNCS procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start31 Jan 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy Due to ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ka-Wai Ho
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Sponsor-investigator, Ka-Wai Ho, Beth Israel Deaconess Medical Center
- Investigators
- Ka-Wai Ho, MD, Principal investigator, Beth Israel Deaconess Medical CenterTamar Berger, MD PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095998
- Sponsor's protocol ID
- 24-766
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07095998
- Acronym / sponsor ID
- 24-766
- Conditions
- Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy, Neurotoxicity Syndromes, Neuropathy
- Keywords
- Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy, Neurotoxicity Syndromes, Neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ka-Wai HoUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy | Experimental | Diagnostic Test: Threshold Tracking Nerve Conduction Studies30 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 |
| Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy | Experimental | Diagnostic Test: Threshold Tracking Nerve Conduction Studies30 participants with cis-PN symptoms will be enrolled and will complete the following: -One-time visit with neurological exams and conduction studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threshold Tracking Nerve Conduction StudiesAlso: TTNC, TTNCSMeasurement 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. | Diagnostic test | Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy, Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy |
Primary outcome
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.
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).
1 secondary outcome
Number of participants who develop neuropathy symptoms as assessed by CTCAE v. 5.0.
Time frame: For Arm A, peripheral neuropathy symptoms will be assessed at baseline and the time of the development of Cis-PN symptoms over the course of 24 weeks. For Arm B, symptoms will be assessed immediately before the TTNCS procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ka-Wai Ho, MD principal investigator
Beth Israel Deaconess Medical Center
Tamar Berger, MD PhD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold Tracking Nerve Conduction Studies in people with Peripheral Neuropathy Due to Chemotherapy and Peripheral Neuropathy, run by Ka-Wai Ho at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ka-Wai Ho, MD (617-667-1665, Kho5@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.