Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy

Rijnstate Hospital20 enrolled

Overview

The goal of this observational study is to learn about the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy for treatment of painful chemotherapy induced peripheral neuropathy. The closed-loop SCS (CL-SCS) system stimulates the nerves in the spinal cord, measures their responses and automatically adjust the stimulation level accordingly in real time for each delivered pulse.

Chemotherapy induced peripheral neuropathy (CIPN) is a serious condition that is diagnosed in up to 40% of patients who require chemotherapy. Conventional treatments for painful CIPN include both pharmacological and non-pharmacological interventions, although the underlying evidence is scarce. Spinal cord stimulation is an established treatment for pain associated with painful peripheral neuropathies. Several studies demonstrate pain relief by open-loop spinal cord stimulation (SCS) in patients with painful CIPN, with a positive effect of SCS on pain and quality of life. In the Netherlands, CIPN is an accepted indication for SCS treatment and thus SCS is a regular treatment for patients with painful and refractory CIPN. The closed-loop SCS (CL-SCS) system stimulates the dorsal column in the spinal cord, measures the response through evoked compound action potentials (ECAPs), and automatically adjust the stimulation level accordingly in real time for each delivered pulse. The current study aims to evaluate the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with CIPN.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)Neuropathic Pain

Medical Language ↔ Plain English

* Subject is deemed a suitable candidate for SCS implantation and has been routinely scheduled to undergo an SCS implantation with the Evoke SCS System. * Subject has a minimum of leg or arm pain intensity of 5/10 on the numeric rating scale (NRS) at baseline due to CIPN. * Patients with CIPN following chemotherapy and at least 6 months post-treatment * CIPN symptoms for a minimum duration of 3 months. * Patient deemed to be in remission per discretion of treating oncologist * No existing contraindications for SCS * Subject is ≥ 18 years old. * Subject is not pregnant or nursing. * Subject is willing and capable of giving informed consent. * No satisfactory treatment effect with anti-neuropathic medication or intolerable side-effects * No satisfactory treatment effect with minimal invasive pain treatments (including ketamine or lidocaine infusion therapy) Exclusion Criteria: * Patient refusal to be included in study * Patients unwilling or mentally incapable to complete the study questionnaires * Other causes of neuropathy (for example diabetic- or small fiber neuropathy) * Previous treatment with SCS for CIPN * Presence of another pain syndrome unrelated to CIPN * History of lower limb amputation or ulceration * Body mass index (BMI) ≥ 40 * Severe psychiatric or neurological disorders * Any other contra indication for locoregional anaesthesia

Outcomes

Primary Outcomes

Overall pain intensity

The primary effectiveness outcome measure is pain intensity measured with the Numeric Rating Scale (NRS; 0 no pain, 10 worst imaginable pain) at 1, 3, 6 and 12 months after SCS implantation.

Time frame: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.

Secondary Outcomes

Pain intensity for the extremities (arms and/or legs)

Pain intensity for the arms and/or legs measured with the Numeric Rating Scale (NRS; 0 no pain, 10 worst imaginable pain).

Time frame: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.

9-Item Patient-Reported Outcomes Measurement Information System (PROMIS-29)

Assessment of quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) all assessed using the PROMIS-29 questionnaire. PROMIS-29 is scored on a T-score metric with a mean of 50 and a standard deviation of 10 in the U.S. general population, with a higher score representing more symptoms.

Time frame: The difference between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.

CIPN-related symptoms

Assessment of CIPN-related symptoms using the European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20). EORTC QLQ-CIPN20 contains 20 items scored on a 4-point Likert scale for sensory, motor and autonomic symptoms. Scale scores are linearly converted to a 0-100 scale, with higher scores indicating increased symptoms.

Time frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.

Medication use

Assessment of pain medication use

Time frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after treatment with closed-loop SCS

Patient Global Impression of Change (PGIC)

Assessment of the patient impression of global improvement with treatment using a 7-point rating scale, ranging from 1 to 7. Higher scores indicate a patient perspective of a worsening of the health condition.

Time frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.

Stimulation coverage and patient stimulation awareness and satisfaction

Assessment of the percentage of stimulation coverage of the painful area, and of stimulation sensation (awareness and quality) during closed-loop spinal cord stimulator (CL-SCS) therapy

Time frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation

SCS stimulation pulse width

The pulse width in milliseconds of the active SCS stimulation program will be collected.

Time frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation.

SCS stimulation frequency

Frequency of the active SCS stimulation program measured in Hertz will be collected

Time frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation.

(Serious) adverse events

Assessment of treatment-related complications