NCT06546371 Spinal Cord Stimulation for Intractable Mononeuropathy
| NCT ID | NCT06546371 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Mononeuropathies |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-05-13 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2024-05-13 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06546371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mononeuropathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06546371 currently recruiting?
Yes, NCT06546371 is actively recruiting participants. Contact the research team at m.m.a.scholtes@erasmusmc.nl for enrollment information.
Where is the NCT06546371 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT06546371 clinical trial?
NCT06546371 is sponsored by Erasmus Medical Center. The trial plans to enroll 12 participants.