Status:
RECRUITING
Spinal Cord Stimulation for Intractable Mononeuropathy
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Mononeuropathies
Spinal Cord Stimulation
Eligibility:
All Genders
18+ years
Phase:
NA
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. How...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06546371
Start Date
May 13 2024
End Date
May 1 2025
Last Update
March 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Erasmus Medical Centre
Rotterdam, South Holland, Netherlands, 3015GD