NCT05857696 Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
| NCT ID | NCT05857696 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Failed Back Surgery Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-02-23 |
| Primary Completion | 2028-10-23 |
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 36 participants in total. It began in 2024-02-23 with a primary completion date of 2028-10-23.
⚠ 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
The purpose of this study is to explore the changes in objective walking parameters induced by medullary stimulation in patients with Fail Back Surgery Syndrome, after chronic stimulation, in comparison with preoperative condition.
Eligibility Criteria
Inclusion Criteria: * Age \> 18 year old and \< or = 70 year old * Patients with chronic neuropathic lumbo-sciatalgia (DN4 score \> or = 4/10) as part of a moderate to severe spinal surgery failure syndrome (EVA \>50/100), in who a collegial and multidisciplinary indication of medullary stimulation treatment was chosen. * Patients awith Social Security Exclusion Criteria: * Vulnerable persons * Patients who are invalid and unable to perform a quantified walk analysis * Contraindication to surgery or anesthesia * Patient not able to complete questionnaires * Woman of childbearing age without effective contraception
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05857696 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Failed Back Surgery Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05857696 currently recruiting?
Yes, NCT05857696 is actively recruiting participants. Contact the research team at legoff.l@chu-nice.fr for enrollment information.
Where is the NCT05857696 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT05857696 clinical trial?
NCT05857696 is sponsored by Centre Hospitalier Universitaire de Nice. The trial plans to enroll 36 participants.