Spinal Cord Stimulation for Intractable Mononeuropathy (SCIMONO)

Spinal Cord Stimulation for Intractable Mononeuropathy: a Pilot Study

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 randomized controlled trial (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 "Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials" (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 Medical Centre.

Study population: 12 patients suffering from intractable peripheral mononeuropathic pain.

Intervention: 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.

Study Overview

• Status: Recruiting
• Conditions: Mononeuropathies; Spinal Cord Stimulation
• Intervention / Treatment: Device: Spinal cord stimulator

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathilde Scholtes, MSc; Phone Number: +31650032165; Email: m.m.a.scholtes@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus Medical Centre
      • Contact: Mathilde Scholtes, MSc; Phone Number: +31650032165; Email: m.m.a.scholtes@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• Pain score on numeric rating scale (NRS) of at least 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal cord stimulation; 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.	Device: Spinal cord stimulator; Electrical stimulation of the dorsal horn to reduce chronic pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity.	Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST).	Quantitative sensory testing (QST) measures sensory thresholds for pain, touch, vibration, and temperature sensations, with the main goal to assess sensory functioning.	6 months
Patient preferences for SCS paradigms as assessed by the perceived pain intensity.	Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable.	3 months
Effect of SCS in patients with mononeuropathy on quality of life.	Quality of life as assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire.	6 months

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Mononeuropathies
• Other Study ID Numbers: MEC-2023-0644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes