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

Failed Back Surgery Syndrome Clinical Trial

— GAITSTIM  

Official title:

Study of the Improvement of Gait by Spinal Stimulation in Patients With Post-operative Chronic Lumbosciatalgia: Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05857696
• Other study ID #: 22-AOI-09
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: LE GOFF Ludovic, MD
• Phone: +334 92 03 55 07
• Email: legoff.l[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Intervention

Other:
• walking quantified analysis
Test to measure anthropometry, joint amplitudes, muscle strength and spasticity of the lower limbs on a treadmill.

Locations

Country	Name	City	State
France	Chu de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To describe the gait alteration in a population of patients with FBSS	Gait quantified analysis with Gait Deviation Index	At baseline, 3 and 6 months after implantation