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Spinal Cord Stimulation for Intractable Mononeuropathy

NCT06546371 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-03

No results posted yet for this study

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

Interventions

DEVICE

Spinal cord stimulator

Electrical stimulation of the dorsal horn to reduce chronic pain.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-13
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06546371 on ClinicalTrials.gov