Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy

NCT03676439 | Recruiting Phase 2 DMC

• 1 other identifier: Andreani, JCM 3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Spastic Cerebral Palsy; Dysarthria

Keywords

Lateral Cord Stimulation; Disability; Magnetic Stimulation; Spasticity; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes in Barthel's Scale

  One pre interventional and monthly - up to three months - post interventional

Study Arms (2)

Treated Arm: Magnetic Spinal Stimulation plus PKT

ACTIVE COMPARATOR

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

Sham comparator

PLACEBO 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

Interventions

Magnetic Spinal Stimulation 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.

Also known as: Neuromodulation

Sham comparator; Treated Arm: Magnetic Spinal Stimulation plus PKT

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sociedad Argenttina de Neuromodulación: lead
• Hospital "San Juan de Dios" - Hurlingham - Argentina: collaborator
• Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina: collaborator

Study Sites (1)

Centro de Rehabilitación San Juan de Dios

Hurlingham, Buenos Aires, 1686, Argentina

RECRUITING

Related Publications (6)

• 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.

  PMID: 22151097 BACKGROUND

• 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.

  PMID: 8001998 BACKGROUND

• 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.

  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.

  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.

  PMID: 25322688 BACKGROUND

• 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.

  PMID: 19268842 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Dysarthria; Muscle Spasticity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Juan Carlos M Andreani, MD

  CENIT Foundation & Sociedad Argentina de Neuromodulación

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Carlos M Andreani, MD

CONTACT

0111550531392; jcmandreani@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient and independent evaluator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: A comparision, Randomized and double blinded study

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 18, 2018
• Study Start: November 18, 2024
• Primary Completion: November 1, 2025
• Study Completion: March 26, 2026
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

AR (1)