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

Not Applicable

Not yet recruiting

• Conditions: Failed Back Surgery Syndrome
• Interventions: Other: walking quantified analysis

• Registration Number: NCT05857696
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

After the informed consent signature, a first assessment will be carried out, including: quantified analysis of walking (AQM), felt effort questionnaire, pain questionnaires, functional abilities, limitations, goals and quality of life.

The implantation of the spinal cord stimulation system will be performed in two stages: the first stage, the electrode alone will be implanted and connected to an external test stimulator, allowing a one-week stimulation test.

If the test is positive (EVA pain improvement \> or = 50%), the second step will be to connect this electrode to a Spectra WaveWriter™ internal stimulator. This stimulator delivers three different stimulation modalities: tonic, microburst and high frequency. The activated initial stimulation mode will be the tonic one.

After 3 months of "tonic" stimulation, the patient will be treated successively and in random way by 3 other different stimulation modalities during a week: microburst, high frequency, stopped stimulation (Off). The AQM and the different questionnaires will be done again, which will determine which stimulation modality is most beneficial to the patient.

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Study Start: 2024-04
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neurostimulation	walking quantified analysis	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.

Primary Outcome Measures

Name	Time	Method
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.	At baseline, 3 and 6 months after implantation	Gait quantified analysis with Gait Deviation Index

Secondary Outcome Measures

Name	Time	Method
To describe the gait alteration in a population of patients with FBSS	At baseline, 3 and 6 months after implantation	Gait quantified analysis with Gait Deviation Index

Trial Locations

Locations (1)

Chu de Nice; 🇫🇷 Nice, France