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Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)

NCT05398003 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-11-18

No results posted yet for this study

Summary

Number of centres planned : 1 (CHU Nantes)

Design : Randomized, Prospective

Planning of the study :

* Total duration: 34 months
* Recruitment period: 24 months.
* Follow-up time per patients : 7-10 months

Expected number of cases : 12

Treatment, procedure, combination of procedures under consideration :

During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode.

There will be a random draw on the order of the stimulation program:

* the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias
* burst stimulation (or "burst")
* high frequency" stimulation (1000 Hz) "High frequency: HF".
* combined tonic + burst stimulation
* combined tonic + high frequency stimulation

Conditions

  • Pain, Intractable

Interventions

DEVICE

Implantation of the WAVEWRITER ALPHA ™ device

The 12 patients will be implanted by the WAVEWRITER ALPHA ™ device. Then, the order of the three stimulation modes will be randomly selected and will be composed of 5 modalities: * tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibres of the posterior cords of the spinal cord induces local paresthesias * high frequency" stimulation (1000 Hz) "High Frequency". * stimulation in bursts (or "Burst")

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2026-09-23
Completion
2026-09-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05398003 on ClinicalTrials.gov