Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)

NCT05857696 | Recruiting

• 1 other identifier: 22-AOI-09
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Failed Back Surgery Syndrome

Keywords

Spinal cord neurostimulation; chronic pain

Outcome Measures

Primary Outcomes (1)

• To explore the changes in objective walking parameters induced by spinal stimulation in patients with FBSS, after 6 months of chronic stimulation, in comparison with preoperative status.

  Gait quantified analysis with Gait Deviation Index

  At baseline, 3 and 6 months after implantation

Secondary Outcomes (1)

• To describe the gait alteration in a population of patients with FBSS

  At baseline, 3 and 6 months after implantation

Study Arms (1)

neurostimulation

OTHER

3 months of tonic stimutaltion + 3 weeks with random stimulation mode between microburst, High frequency, stopped stimulation (Off) then stimulation with the more efficient mode (according the patient) until 6 monthe after implantation.

Other: walking quantified analysis

Interventions

walking quantified analysis OTHER

Test to measure anthropometry, joint amplitudes, muscle strength and spasticity of the lower limbs on a treadmill.

neurostimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Chu de Nice

Nice, 06200, France

RECRUITING

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

LE GOFF Ludovic, MD

CONTACT

+334 92 03 55 07; legoff.l@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective study on the evolution of spatial-temporal parameters of walking for each mode of medullary neurostimulation.

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: February 23, 2024
• Primary Completion (Estimated): October 23, 2028
• Study Completion (Estimated): October 23, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)