Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy

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

Study Overview

• Status: Recruiting
• Conditions: Spastic Cerebral Palsy; Dysarthria
• Intervention / Treatment: Device: Magnetic Spinal Stimulation

Detailed Description

Cerebral Palsy (CP) is a chronic and non-progressive morbid disease that affects psychomotor development, with multiple etiologies that share a common condition of acquired perinatal anomalies during development.

The manifestations are multiple and varied, with more frequent motor disorders, speech disorders, mental retardation, spasticity, dystonia, etc.. About a third of these patients have a normal IQ, for whom those signs are more disabling than for others, and for refractory speech problems there is no therapy available These subjects have generally been unsuccessfully treated with medications, botulinum toxin injections, rehabilitation or kinesic orthosis, maintaining their abnormal stable conditions at the end of childhood or early adulthood.

The rational for this clinical trial is that the author has demonstrated the reduction of the excitability threshold of the nociceptive response by electrically stimulating the lateral spinal cord in an animal model, therefore, its possible beneficial action on abnormal muscle tone, somatic motor functions and improvement of speech, by this method.

Spastic Cerebral Palsy has been chosen as a targeted population, because it use to be a chronic and irreversible condition with few therapeutic options, ineffective and frequent complications.

It is of ancient knowledge that electric currents can alter the functions of the Nervous System In the last decades there was a refinement of these techniques of stimulation, being able to emphasize especially the Transcranial or Spinal Magnetic Stimulation (TMS). This therapeutic method, developed in the eighties, is able to modulate brain activity, through the stimulation of limited cortical or spinal areas, with minimal side effects, which is applied through a coil that produces an alternating electrical current.

The constant change of orientation of this alternating current generates a powerful electromagnetic field, capable of crossing the cranial scalp and the skull bone or the osteo-ligamentary structures and originating an electric current restricted to small areas of the brain, cerebellum or spinal cord The objective of the present clinical trial is to demonstrate the therapeutic effect of focal stimulation of the spinal cord in speech and motor function assessed by Modifyied Aschworth sacale and speech, evaluated through Functional Independence Measure (FIM) Scale, selected cases of spastic CP The rational is to focus the magnetic impact on the lateral surface of the spinal cord, trying to stimulate the spinocerebellar tracts, because of its superficial location, therefore, more accessible.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Juan Carlos M Andreani, MD; Phone Number: 0111550531392; Email: jcmandreani@gmail.com

Study Locations

• Argentina
  • Buenos Aires
    • Hurlingham, Buenos Aires, Argentina, 1686
      • Recruiting
      • Centro de Rehabilitación San Juan de Dios
      • Contact: Juan Carlos M Andreani; Phone Number: 5491150531392; Email: jcmandreani@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treated Arm: Magnetic Spinal Stimulation plus PKT; Three months of kinesthetic and phoniatric treatment, and Magnetic Spinal Stimulation, 80% of the cervical muscles's motor threshold, 100 pulses at 10Hz, lasting 10 seconds, repeated during 30 minutes, twice a week for 3 months on cervical lateral location, focalized on the Lateral Spinal Cord.	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.; Other Names: Neuromodulation
Placebo Comparator: Sham comparator; They will receive kinesthetic and phoniatric treatment, and during 3 months,with equal periodicity, they will receive a sensible false magnetic stimulation, of equal localization that other arm, with insufficient intensity, to blind clinical experience.	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.; Other Names: Neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sociedad Argenttina de Neuromodulación
• Collaborators: Hospital "San Juan de Dios" - Hurlingham - Argentina; Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina
• Investigators: Study Director: Juan Carlos M Andreani, MD, CENIT Foundation & Sociedad Argentina de Neuromodulación; Principal Investigator: Werner Braunsdorf, MD, Klinik von Magdeburg - Germany; Principal Investigator: Wojciech Maksymowicz, MD, University of Warmia and Mazury in Olsztyn- Poland; Principal Investigator: Tommaso Tufo, MD, Policlinico A. Gemelli University Hospital Foundation - Rome - Italy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 18, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): March 26, 2026

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 16, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Spinal Cord Stimulation; Lateral Cord Stimulation; Disability; Magnetic Stimulation; Spasticity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Language Disorders; Communication Disorders; Muscle Hypertonia; Speech Disorders; Articulation Disorders; Cerebral Palsy; Muscle Spasticity; Dysarthria
• Other Study ID Numbers: Andreani, JCM 3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No