Spastic Cerebral Palsy Clinical Trial
Official title:
Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy - Multicenter Double Blind Randomized and Controlled Trial
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
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 26, 2026 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 50 Years |
Eligibility | Inclusion Criteria: - Age 16 years or older. - Spastic Cerebral Palsy with stable condition. - Motor disability unilateral or predominantly unilateral. - Clinically evident speech disorders. - Normal or slightly subnormal intellectual coefficient (I.Q 80 or more) - Absence of psychiatric disorders Exclusion Criteria: - Cardiac or severe respiratory disorders. - Steady abnormal postures (except possible orthopedic surgical correction) - Recurrent chronic bronchial or pulmonary infections. - Psychiatric disorders - Chronic recurrent urinary infections - Severe osteoporosis in affected limbs - Chronic skin ulcers - Drug addiction. - Episodes of Status Epileptucus - Personal history, or in close relatives, of medical legal complaint |
Country | Name | City | State |
---|---|---|---|
Argentina | Centro de Rehabilitación San Juan de Dios | Hurlingham | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Sociedad Argenttina de Neuromodulación | Hospital "San Juan de Dios" - Hurlingham - Argentina, Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina |
Argentina,
Abdeen MA, Stuchly MA. Modeling of magnetic field stimulation of bent neurons. IEEE Trans Biomed Eng. 1994 Nov;41(11):1092-5. doi: 10.1109/10.335848. — View Citation
Andreani JC, Guma C. Lateral cord stimulation decreases spastic electromyographic spreading: responses in a brain-damaged pig preparation. Neuromodulation. 2008 Jul;11(3):202-7. doi: 10.1111/j.1525-1403.2008.00167.x. — View Citation
Andreani, JCM, Guma C. Lateral Cord Stimulation (LCS) to relieve spasticity experimental protocol and results. Proceedings of the 10th Conference of the International Federation of Electrical Stimulation (IFESS) Montreal-Canada, July 4-8th 2005. pp 153-5.
Duchenne de Boulogne. De l'électrisation localisée et de son application à la physiologie, à la pathologie et à la thérapeutique (3e édition). Librairie JB Bailiere et fils. Paris. 1872.
Koy A, Pauls KA, Flossdorf P, Becker J, Schonau E, Maarouf M, Liebig T, Fricke O, Fink GR, Timmermann L. Young adults with dyskinetic cerebral palsy improve subjectively on pallidal stimulation, but not in formal dystonia, gait, speech and swallowing testing. Eur Neurol. 2014;72(5-6):340-8. doi: 10.1159/000360984. Epub 2014 Oct 14. — View Citation
Lefaucheur JP. Methods of therapeutic cortical stimulation. Neurophysiol Clin. 2009 Feb;39(1):1-14. doi: 10.1016/j.neucli.2008.11.001. Epub 2008 Nov 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Modified Ashworth Scale (MAS) | Scale evaluationg muscle stiffness, from 0(normal) to 5 (maximal rigidity). It wiil be employed to evaluate the spasticity related to limbs. | One pre interventional and monthly - up to three months - post interventional | |
Primary | Changes in Functional Independence measure (FIM) for the speech. | The FIM measures what an individual can perform - Only the ability for communication, comprehension and expression, will be evaluated to assess speech changes | One pre interventional and monthly - up to three months - post interventional | |
Secondary | Changes in Barthel's Scale | The Barthel Index for Activities of Daily Living (ADL) assesses functional independence, into 10 activities of daily living. Values range from 0 -100, will be investigated to evaluate whole functional changes | One pre interventional and monthly - up to three months - post interventional |
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