Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy
NCT03676439 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-11-21
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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