Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy

Phase 4Not Yet RecruitingNCT06596200

University of Maryland St. Joseph Medical Center10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chemotherapy-induced Peripheral Neuropathy

Interventions

Spinal Cord Stimulation ImplantDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

-- 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.

Time frame: 1 year

Secondary Outcomes

- - 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.

Time frame: 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.

Time frame: 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.

Time frame: 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").

Time frame: 1 year

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

Central Contacts

Aja Janyavula, MD, MPH

CONTACT

4104275459 UMSJMCtrials@umm.edu

Data from ClinicalTrials.gov

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