Peripheral Nerve StimulationNCT06162403
Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study
A study testing Peripheral Nerve Stimulation in people with Peripheral Nerve Stimulation and Chemotherapy-induced Peripheral Neuropathy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Nerve Stimulation, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Peripheral Nerve Stimulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 31 Dec 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with chronic (≥90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizing irradiation) of the lower extremity, seen at Pain Management Center at MD Anderson Cancer Center
- Participants reports baseline pain ≥ 4 (0-10 scale, NRS)
- Participants between ages 18-85 years old
- Participants who have completed chemotherapy within the previous year at the time of enrollment
Who cannot join
- Participants with cognitive dysfunction
- Participants with recent history (<6 months) of drug or alcohol abuse
- Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- Participants with allergies to local anesthesia, steroids, or adhesives
- Participants with conditions that conflict with the SPRINT PNS System Indications for Use, including Contraindications and Warnings.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Saba Javed, MD, 713-792-9530, sjaved@mdanderson.org
Saba Javed, MD
About this study
To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.
Read the detailed description
Primary objective:
To assess Pain intensity (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of peripheral nerve stimulation (PNS).
Secondary objectives:
To assess changes in quantitative sensory testing (QST), gait testing, and skin punch biopsy to compare the integrity of Meissner's corpuscles (MC), pain disability using the Oswestry Disability Index (ODI), pain interference using the Brief Pain Inventory (BPI), and Patient Global Impression of Change (PGIC) in CIPN patients before and after use of PNS.
- Being tested
- Peripheral Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve StimulationOther
The leads are inserted through a needle. If needed, the study team may give participants anesthetic (for example, as a cream/gel on your skin and/or as an injection) to numb the area where the leads will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Nerve Stimulation | Experimental | Participants will be asked to have PNS leads inserted via a needle, which will provide a mild, stimulating electrical current to the effected nerves 24 hours a day for up to 60 days. Participants will have study visits during and after this time. Receives: Other: Peripheral Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start22 Feb 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve StimulationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Javed, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162403
- Sponsor's protocol ID
- 2023-0368
- Other IDs
- NCI-2023-10303
- Status last verified
- Aug 2026
- First submitted
- 30 Nov 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study
- ClinicalTrials.gov ID
- NCT06162403
- Acronym / sponsor ID
- 2023-0368
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Dec 2023 (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.
To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.
Detailed description
Primary objective:
To assess Pain intensity (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of peripheral nerve stimulation (PNS).
Secondary objectives:
To assess changes in quantitative sensory testing (QST), gait testing, and skin punch biopsy to compare the integrity of Meissner's corpuscles (MC), pain disability using the Oswestry Disability Index (ODI), pain interference using the Brief Pain Inventory (BPI), and Patient Global Impression of Change (PGIC) in CIPN patients before and after use of PNS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Nerve Stimulation | Experimental | Other: Peripheral Nerve StimulationParticipants will be asked to have PNS leads inserted via a needle, which will provide a mild, stimulating electrical current to the effected nerves 24 hours a day for up to 60 days. Participants will have study visits during and after this time. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants diagnosed with chronic (≥90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizing irradiation) of the lower extremity, seen at Pain Management Center at MD Anderson Cancer Center
- Participants reports baseline pain ≥ 4 (0-10 scale, NRS)
- Participants between ages 18-85 years old
- Participants who have completed chemotherapy within the previous year at the time of enrollment
Key exclusion criteria (5 listed)
- Participants with cognitive dysfunction
- Participants with recent history (<6 months) of drug or alcohol abuse
- Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- Participants with allergies to local anesthesia, steroids, or adhesives
- Participants with conditions that conflict with the SPRINT PNS System Indications for Use, including Contraindications and Warnings.
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 |
|---|---|---|
| Peripheral Nerve StimulationThe leads are inserted through a needle. If needed, the study team may give participants anesthetic (for example, as a cream/gel on your skin and/or as an injection) to numb the area where the leads will be injected. | Other | Peripheral Nerve Stimulation |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 10 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
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Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
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Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
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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.
Saba Javed, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Nerve Stimulation in people with Peripheral Nerve Stimulation and Chemotherapy-induced Peripheral Neuropathy, run by M.D. Anderson Cancer Center at 1 site 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 5 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Saba Javed, MD ((713) 792-9530, sjaved@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). 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 10 Aug 2026.