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NCT Number: NCT05857696

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

walking quantified analysis

Other

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

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.

    Time frame: At baseline, 3 and 6 months after implantation

    Gait quantified analysis with Gait Deviation Index

Secondary outcomes

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

    Time frame: At baseline, 3 and 6 months after implantation

    Gait quantified analysis with Gait Deviation Index

Study contacts

Contact information is provided by the study sponsor or research team.

LE GOFF Ludovic, MD

CONTACT

[email protected]

+334 92 03 55 07

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: GAITSTIM

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 12, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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