Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
NCT ID: NCT05857696
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2024-04-30
2026-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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neurostimulation
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.
walking quantified analysis
Test to measure anthropometry, joint amplitudes, muscle strength and spasticity of the lower limbs on a treadmill.
Interventions
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walking quantified analysis
Test to measure anthropometry, joint amplitudes, muscle strength and spasticity of the lower limbs on a treadmill.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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Chu de Nice
Nice, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-AOI-09
Identifier Type: -
Identifier Source: org_study_id
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