NCT03764514

Brief Summary

This is an observational based pilot study evaluating the use of spinal cord stimulators for the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 3, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2022

Completed
Last Updated

September 24, 2024

Status Verified

March 1, 2023

Enrollment Period

3.4 years

First QC Date

December 3, 2018

Last Update Submit

September 20, 2024

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Permanent Spinal Cord Stimulator Implantation

    To determine the total number of patients who undergo permanent spinal cord stimulator implantation.

    2 years

Secondary Outcomes (2)

  • Subjective Pain Assessment: Brief Pain Inventory-Short Form

    2 years

  • Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment

    2 years

Study Arms (1)

Spinal Cord Stimulator - Permanent Implantation

Device: Spinal Cord Stimulator

Interventions

Spinal Cord StimulatorDEVICE

Permanent Implantation

Spinal Cord Stimulator - Permanent Implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • The patient has persistent, severe peripheral neuropathy secondary to chemotherapy

You may not qualify if:

  • Refusal to undergo a spinal cord stimulator procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patewood Memorial Hospital

Greenville, South Carolina, 29615, United States

Location

Related Publications (1)

  • Braun Filho JL, Braun LM. [Spinal cord stimulation in the treatment of refractory painful polineuropathy induced by chemotherapy.]. Rev Bras Anestesiol. 2007 Oct;57(5):533-8. doi: 10.1590/s0034-70942007000500008. Portuguese.

    PMID: 19462129BACKGROUND

Study Officials

  • Joshua Smith, MD

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 5, 2018

Study Start

December 3, 2018

Primary Completion

May 3, 2022

Study Completion

May 3, 2022

Last Updated

September 24, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)