Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy
- Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Interventions
- Device: Spinal Cord Stimulation Implant
- Registration Number
- NCT06596200
- Lead Sponsor
- University of Maryland St. Joseph Medical Center
- 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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Group - SCS Spinal Cord Stimulation Implant 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.
- Primary Outcome Measures
Name Time Method -- 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
Name Time Method - - 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 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.
- Pain interference in daily life will be quantified via the brief pain inventory (BPI). 1 year 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.
- Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS). 1 year 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.
- The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC). 1 year 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").
- 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