Spinal Cord Stimulation for Intractable Mononeuropathy (SCIMONO)

Erasmus University

Status: Enrolling

Conditions: Mononeuropathies; Spinal Cord Stimulation

Treatments: Device: Spinal cord stimulator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06546371

MEC-2023-0644

Details and patient eligibility

About

Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large RCT we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the IMMPACT guidelines, and assess the stimulation paradigm preferences in these patients.

Objective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done. Study design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus MC. Study population: 12 patients suffering from intractable peripheral mononeuropathic pain Intervention (if applicable): Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months. Main study parameters/endpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (EMG)
• Symptoms refractory to conventional medical management for at least 6 months according to treating physician
• 18 years or older
• At least NRS 5 (average pain intensity in week prior to assessment)
• Stable or absent concomitant analgesics

Exclusion criteria

• Mononeuropathy located in the head or torso
• Mononeuropathy by avulsion at the plexus brachialis
• Life expectancy <1 year
• Anticoagulant drug therapy or disturbed coagulation
• Immune-compromised patients
• Pregnancy
• Lack of cooperation of the patient or patient has a history of noncompliance with regard to (a) medical regime(s)
• Patients with psychological factors or addiction that require treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Spinal cord stimulation

Experimental group

Description:

Patients are all included in this experimental arm, where they receive all four stimulation options consecutively, but in different orders. After receiving all four stimulation options, the patients are allowed to choose which stimulation option of the four they want to have for the following period.

Treatment:

Device: Spinal cord stimulator