Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy

NCT03676439 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-21

No results posted yet for this study

Summary

Lateral cord stimulation (LCS) was discovered by the author as the producer of an average threshold increase for abnormal muscle contraction responses, in experimental pathological conditions, as described and referred.

This physiological effect is proposed to improve tone, motor function and speech, in patients with spasticity of different causes, such as cerebrovascular accident, congenital brain malformations, perinatal anoxia (image called cerebral palsy), sequels of neurosurgery, etc.

Due to its non-invasiveness and possible efficacy, the use of magnetic stimulation is proposed to try to demonstrate its therapeutic utility.

This is the clinical test of phase 2/3 of the method, in the future, and how its use could be extended, if the results were positive, its indications could be extended to other pathological conditions, giving a greater spectrum of spastic patients, potentially benefited

Conditions

  • Spastic Cerebral Palsy
  • Dysarthria

Interventions

DEVICE

Magnetic Spinal Stimulation

Spinal Magnetic Stimulation (TMS) on Lateral Cord Stimulation (LCS), in the search of the improvement of the tone, motor function and speech, in patients with spastic cerebral Palsy. Due to its non-invasiveness and possible efficacy, the use of Magnetic Spinal Stimulation is proposed to try to prove its therapeutic usefulness. This is the phase 2/3 clinical test of the method, in the future, and as its use could be extended, if the results were positive, its indications could be extended to other pathological conditions, giving a greater spectrum of spastic patients, potentially benefited.

Sponsors & Collaborators

  • Hospital "San Juan de Dios" - Hurlingham - Argentina

    collaborator UNKNOWN
  • Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina

    collaborator UNKNOWN
  • Sociedad Argenttina de Neuromodulación

    lead OTHER

Principal Investigators

  • Juan Carlos M Andreani, MD · CENIT Foundation & Sociedad Argentina de Neuromodulación

  • Werner Braunsdorf, MD · Klinik von Magdeburg - Germany

  • Wojciech Maksymowicz, MD · University of Warmia and Mazury in Olsztyn- Poland

  • Tommaso Tufo, MD · Policlinico A. Gemelli University Hospital Foundation - Rome - Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-11-01
Completion
2026-03-26

Countries

  • Argentina

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 NCT03676439 on ClinicalTrials.gov