Exploring the Benefit of Neuromodulation in Treating Chem... | NCT06121232

Studies
Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study

NCT06121232

Sponsor

M.D. Anderson Cancer Center

Status

Active, not recruiting

Last Update Posted

May 26, 2026Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Neuropathy;Peripheral

Interventions

Abbott® DRG / Abbott®/Medtronic® SCS
Control Group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2023-09269	Other Identifier	NCI-CTRP Clinical Trials Registry

Brief Title

Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study

Official Title

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2023Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Oct 25, 2023

First Submission Date that Met QC Criteria

Nov 2, 2023

First Posted Date

Nov 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2026

Last Update Posted Date

May 26, 2026Actual

Name	Class
Foundation for Anesthesia Education and Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To learn if a process called neuromodulation can help to improve pain due to CIP

Detailed Description

Inclusion Criteria:

Ability to understand and the willingness to sign a written informed consent document
Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds
Patients seen at Pain Management Center at MD Anderson Cancer Center
Patient ages greater or equal to 18 years but less than or equal to 85 years

Exclusion Criteria:

Patients with cognitive dysfunction
Patient with recent history (<6 months) of drug or alcohol abuse
Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental	Group 1 will receive neuromodulation.	Device: Abbott® DRG / Abbott®/Medtronic® SCS
Control Group	Experimental	Group 2 will not receive neuromodulation.	Other: Control Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abbott® DRG / Abbott®/Medtronic® SCS	Device	Participants will receive 1 of 2 neuromodulation procedures based on if participants are expected to have an MRI in the near future.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0		through study completion; an average of 1 year.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to understand and the willingness to sign a written informed consent document
Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds
Patients seen at Pain Management Center at MD Anderson Cancer Center
Patient ages greater or equal to 18 years but less than or equal to 85 years

Exclusion Criteria

Patients with cognitive dysfunction
Patient with recent history (<6 months) of drug or alcohol abuse
Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Saba Javed, M D	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
M D Anderson Cancer Center	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design
D008722	Methods