Chemotherapy-induced Peripheral Neuropathy
Conditions
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%.
Interventions
DEVICESpinal Cord Stimulation Implant
Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord
Sponsors
University of Maryland St. Joseph Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| - - 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 | — |
Contacts
Primary ContactAja Janyavula, MD, MPH
Outcome results
None listed