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Chronic Spinal Cord Injury Rehabilitation with Laparoscopic Neuromodulation

Results of laparoscopic implantation of neuromodulator on patients with spinal cord injury.

Status
Recruiting
Phases
Phase 3
Study type
Observational
Source
REBEC
Registry ID
RBR-9bt4xv5
Enrollment
Unknown
Registered
2021-02-04
Start date
2013-12-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic paraplegia and spastic tetraplegia

Interventions

This will be a randomized prospective pilot study. 40 patients aged 18 to 60 years, with partial or complete SCI from T1 to T12, with the ASIA A or B score, using intermittent catheterization and / or
E02.831.535.468.699

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Medtronic inc
Collaborator
ASSOCIAÇÃO DE ENSINO, PESQUISA E ASSISTÊNCIA A SAÚDE - AEPAS
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Individuals aged 18 to 60 years;with partial or complete LRM from T1 to T12;with ASIA A or B score;using intermittent catheterization; with urinary incontinence;with neurological stability greater than one year

Exclusion criteria

Exclusion criteria: Patients with cognitive limitations;bladder atony to urodynamic study;suspected vesicoureteral reflux prior to SCI;Diabetes Mellitus, compensated or not;congenital or acquired immunodeficiencies;suspected or diagnosed malignant neoplasm;history of restosigmoidectomy, colectomy, or other surgery on the digestive system that may cause changes in intestinal transit, anal continence or evacuation function

Design outcomes

Primary

MeasureTime frame
Impact of electrostimulation of lumbosacral nerves, through laparoscopic implantation of electrostimulators, in gait using the WISCI-II scale in patients with spinal cord injury

Secondary

MeasureTime frame
Impact of electrostimulation of lumbosacral nerves, through laparoscopic implantation of electrostimulators, in bladder, intestinal, vasomotor and sexual functions, in muscle spasticity of the pelvic floor and lower limbs and in the quality of sleep of people with SCI

Countries

Brazil

Contacts

Public ContactGustavo Fernandes
gustavo.fernandes@increasing.com.br+55 11 39386188

Outcome results

None listed

Source: REBEC (via WHO ICTRP)