Spinal Cord Stimulation for Intractable Mononeuropathy

NCT06546371 | Recruiting FDA Device

• 1 other identifier: MEC-2023-0644
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mononeuropathies; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST).

  6 months

• Effect of SCS in patients with mononeuropathy on quality of life.

  6 months

• Patient preferences for SCS paradigms as assessed by the perceived pain intensity.

  3 months

Study Arms (1)

Spinal cord stimulation

EXPERIMENTAL

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

Interventions

Spinal cord stimulator DEVICE

Electrical stimulation of the dorsal horn to reduce chronic pain.

Spinal cord stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Erasmus Medical Centre

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Mononeuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Mathilde Scholtes, MSc

CONTACT

+31650032165; m.m.a.scholtes@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Centre for Pain Medicine

Model Details: Mono-center explorative pilot study in 12 patients

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: August 9, 2024
• Study Start: May 13, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)