Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal Cord Stimulation Implant.
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Peripheral Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study for the Use of Spinal Cord Stimulation to Alleviate Pain from Chemotherapy Induced Peripheral Neuropathy Due to Taxane or Platinum Based Agents
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%.
Interventions
- Device Spinal Cord Stimulation Implant
Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord
Primary outcome measures
- -- 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 outcome measures (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. [Time frame: 1 year]
- - Pain interference in daily life will be quantified via the brief pain inventory (BPI). [Time frame: 1 year]
- - Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS). [Time frame: 1 year]
- - The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC). [Time frame: 1 year]
- - Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire. [Time frame: 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. [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06596200 · 00110894