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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05857696

Collaborator

(none)

Enrollment

Location

Arm

32.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Failed Back Surgery Syndrome	Other: walking quantified analysis	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective study on the evolution of spatial-temporal parameters of walking for each mode of medullary neurostimulation.Prospective study on the evolution of spatial-temporal parameters of walking for each mode of medullary neurostimulation.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Other: 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.

Other: walking quantified analysis

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

Outcome Measures

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. [At baseline, 3 and 6 months after implantation]
Gait quantified analysis with Gait Deviation Index

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu de Nice	Nice		France	06200

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT05857696

Other Study ID Numbers:

22-AOI-09

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Nice

Spinal cord neurostimulation

chronic pain

Additional relevant MeSH terms:

Failed Back Surgery Syndrome

Study Results

No Results Posted as of May 12, 2023