Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy

NCT ID: NCT03676439

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2026-03-26

Brief 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

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.

Conditions

Spastic Cerebral Palsy; Dysarthria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Magnetic Spinal Stimulation

Intervention Type: DEVICE

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.

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.

Group Type: PLACEBO_COMPARATOR

Magnetic Spinal Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Neuromodulation

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital "San Juan de Dios" - Hurlingham - Argentina

UNKNOWN

Sponsor Role: collaborator

Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina

UNKNOWN

Sponsor Role: collaborator

Sociedad Argenttina de Neuromodulación

OTHER

Sponsor Role: lead

Responsible Party

Juan Carlos M. Andreani MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Carlos M Andreani, MD

Role: STUDY_DIRECTOR

CENIT Foundation & Sociedad Argentina de Neuromodulación

Werner Braunsdorf, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik von Magdeburg - Germany

Wojciech Maksymowicz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Warmia and Mazury in Olsztyn- Poland

Tommaso Tufo, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico A. Gemelli University Hospital Foundation - Rome - Italy

Locations

Centro de Rehabilitación San Juan de Dios

Hurlingham, Buenos Aires, Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Juan Carlos M Andreani, MD

Role: CONTACT

jcmandreani@gmail.com

0111550531392

Facility Contacts

Juan Carlos M Andreani

Role: primary

jcmandreani@gmail.com

5491150531392

References

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.

Reference Type: BACKGROUND

PMID: 22151097 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8001998 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 25322688 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19268842 (View on PubMed)

Other Identifiers

Andreani, JCM 3

Identifier Type: -

Identifier Source: org_study_id