Recruiting

Neuromodulation

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06121232

Conditions

Neuropathy;Peripheral

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abbott® DRG / Abbott®/Medtronic® SCS

Control Group

Study Details

Brief summary:

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

Conditions

Neuropathy;Peripheral

Study ID

NCT06121232

Start date

Nov 2, 2023

Status verified date

Sep, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Group 1 will receive neuromodulation.

experimental: Control Group

Group 2 will not receive neuromodulation.

Interventions

Abbott® DRG / Abbott®/Medtronic® SCS

Participants will receive 1 of 2 neuromodulation procedures based on if participants are expected to have an MRI in the near future.

Control Group

Participants will not receive any intervention

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Saba Javed, M D

(713) 792-9530sjaved@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Saba Javed, M D

713-792-9530sjaved@mdanderson.org

Principal Investigator:

Saba Javed, M D

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.