Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy

Pilot Study for the Use of Spinal Cord Stimulation to Alleviate Pain from Chemotherapy Induced Peripheral Neuropathy Due to Taxane or Platinum Based Agents

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%.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Device: Spinal Cord Stimulation Implant

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Aja Janyavula, MD, MPH; Phone Number: 4104275459; Email: UMSJMCtrials@umm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group - SCS; 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; Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
-- 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
- - 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.	CIPN20 is a 20-item patient questionnaire with items scored 1 to 4. Scores vary from 20 to 80, with higher scores indicating more prevalent neuropathy symptoms.	1 year
- Pain interference in daily life will be quantified via the brief pain inventory (BPI).	BPI includes reported pain severity (NRS) and a 7-item questionnaire assessing pain interference with each item scored 0-10 with higher scores indicating worsened pain interference.	1 year
- Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS).	The mTCNS is a clinician administered exam with 11 items scored 0-3. A normal score is 0 with higher scores indicating worsened neuropathy on physical exam, up to a maximum of 33.	1 year
- The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC).	PGIC is a 7 point scale rating their impression (1-"very much improved", 2-"much improved", 3-"minimally improved", 4-"no change", 5-"minimally worse", 6-"much worse", 7-"very much worse").	1 year
- Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire.		1 year
- Any treatment related adverse events observed during the trial will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0.		1 year

Collaborators and Investigators

• Sponsor: University of Maryland St. Joseph Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2024
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 00110894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No