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

Primary Purpose

Failed Back Surgery Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
walking quantified analysis
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Failed Back Surgery Syndrome focused on measuring Spinal cord neurostimulation, chronic pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu de Nice

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

neurostimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To describe the gait alteration in a population of patients with FBSS
Gait quantified analysis with Gait Deviation Index

Full Information

First Posted
May 4, 2023
Last Updated
September 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05857696
Brief Title
Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
Acronym
GAITSTIM
Official Title
Study of the Improvement of Gait by Spinal Stimulation in Patients With Post-operative Chronic Lumbosciatalgia: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
Keywords
Spinal cord neurostimulation, chronic pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective study on the evolution of spatial-temporal parameters of walking for each mode of medullary neurostimulation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neurostimulation
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
walking quantified analysis
Intervention Description
Test to measure anthropometry, joint amplitudes, muscle strength and spasticity of the lower limbs on a treadmill.
Primary Outcome Measure Information:
Title
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.
Description
Gait quantified analysis with Gait Deviation Index
Time Frame
At baseline, 3 and 6 months after implantation
Secondary Outcome Measure Information:
Title
To describe the gait alteration in a population of patients with FBSS
Description
Gait quantified analysis with Gait Deviation Index
Time Frame
At baseline, 3 and 6 months after implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LE GOFF Ludovic, MD
Phone
+334 92 03 55 07
Email
legoff.l@chu-nice.fr
Facility Information:
Facility Name
Chu de Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LE GOFF Ludovic
Phone
+33492035507
Email
legoff.l@chu-nice.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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