Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy

NCT06596200 | Not Yet Recruiting Phase 4 FDA Device

• 1 other identifier: 00110894
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• -- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant.

  1 year

Secondary Outcomes (6)

• - - Neuropathy symptoms will be quantified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (CIPN20). CIPN20 is a 20-item patient questionnaire with items scored 1 to 4.

  1 year

• - Pain interference in daily life will be quantified via the brief pain inventory (BPI).

  1 year

• - Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS).

  1 year

• - The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC).

  1 year

• - Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire.

  1 year

Study Arms (1)

Intervention Group - SCS

EXPERIMENTAL

Patients who are eligible will receive a trial implant for a 3-7 day trial period. If there is at least 50% pain relief in the trial period, the patients will receive the permanent SCS implant and will be followed for 1 year post permanent implant.

Device: Spinal Cord Stimulation Implant

Interventions

Spinal Cord Stimulation Implant DEVICE

Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord

Intervention Group - SCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CIPN as diagnosed by Oncology and/or neurology
• Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
• Pain severity greater than 4 out of 10 on a numeric rating scale of pain
• Pain chronicity greater than 6 months after the cessation of chemotherapy
• Failure of medical therapy, which must have included duloxetine
• Age 18 or greater

You may not qualify if:

• Platelet count less than 100k/mm3
• Spinal anatomy precluding placement of the SCS leads between T6 and T11
• Active infection
• Estimated Lifespan less than 1 year
• Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months

Sponsors & Collaborators

• University of Maryland St. Joseph Medical Center: lead

MeSH Terms

Interventions

Spinal Cord Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Aja Janyavula, MD, MPH

CONTACT

4104275459; UMSJMCtrials@umm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: November 15, 2025
• Study Completion (Estimated): November 15, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share