Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the Netherlands / NCT06546371
Recruiting Not applicable

Spinal Cord Stimulation for Intractable Mononeuropathy

NCT06546371 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Not applicable
Started
2024-05-13
Last updated
2025-03-03

Condition(s) studied

MononeuropathiesSpinal Cord Stimulation

Investigational drug(s) / intervention(s)

Spinal cord stimulator

Spinal cord stimulator: Electrical stimulation of the dorsal horn to reduce chronic pain.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity. — 6 months
    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.

Trial sites (1)

FacilityCityRegionStatus
Erasmus Medical Centre Rotterdam South Holland Recruiting

More Erasmus Medical Center trials in the Netherlands

HS ABSCESSES: I&D VS PUNCH DEBRIDEMENT Starting soon
Thermotherapy for Locally Advanced Head and Neck Cancer Active, not recruiting
Impact of CES1 Genotype on Capecitabine Exposure in Cancer Patients Recruiting
Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06546371 on ClinicalTrials.gov ↗ ← All trials in the Netherlands