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Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy

Primary Purpose

Spastic Cerebral Palsy, Dysarthria

Status
Recruiting
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
Magnetic Spinal Stimulation
Sponsored by
Sociedad Argenttina de Neuromodulación
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Lateral Cord Stimulation, Disability, Magnetic Stimulation, Spasticity, Spinal Cord Stimulation

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Rehabilitación San Juan de DiosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treated Arm: Magnetic Spinal Stimulation plus PKT

Sham comparator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
September 4, 2018
Last Updated
October 27, 2022
Sponsor
Sociedad Argenttina de Neuromodulación
Collaborators
Hospital "San Juan de Dios" - Hurlingham - Argentina, Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina
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1. Study Identification

Unique Protocol Identification Number
NCT03676439
Brief Title
Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy
Official Title
Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy - Multicenter Double Blind Randomized and Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
March 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Argenttina de Neuromodulación
Collaborators
Hospital "San Juan de Dios" - Hurlingham - Argentina, Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy, Dysarthria
Keywords
Lateral Cord Stimulation, Disability, Magnetic Stimulation, Spasticity, Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A comparision, Randomized and double blinded study
Masking
ParticipantOutcomes Assessor
Masking Description
Patient and independent evaluator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated Arm: Magnetic Spinal Stimulation plus PKT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham comparator
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic Spinal Stimulation
Other Intervention Name(s)
Neuromodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Modified Ashworth Scale (MAS)
Description
Scale evaluationg muscle stiffness, from 0(normal) to 5 (maximal rigidity). It wiil be employed to evaluate the spasticity related to limbs.
Time Frame
One pre interventional and monthly - up to three months - post interventional
Title
Changes in Functional Independence measure (FIM) for the speech.
Description
The FIM measures what an individual can perform - Only the ability for communication, comprehension and expression, will be evaluated to assess speech changes
Time Frame
One pre interventional and monthly - up to three months - post interventional
Secondary Outcome Measure Information:
Title
Changes in Barthel's Scale
Description
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
Time Frame
One pre interventional and monthly - up to three months - post interventional

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos M Andreani, MD
Phone
0111550531392
Email
jcmandreani@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Carlos M Andreani, MD
Organizational Affiliation
CENIT Foundation & Sociedad Argentina de Neuromodulación
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Werner Braunsdorf, MD
Organizational Affiliation
Klinik von Magdeburg - Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wojciech Maksymowicz, MD
Organizational Affiliation
University of Warmia and Mazury in Olsztyn- Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tommaso Tufo, MD
Organizational Affiliation
Policlinico A. Gemelli University Hospital Foundation - Rome - Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Rehabilitación San Juan de Dios
City
Hurlingham
State/Province
Buenos Aires
ZIP/Postal Code
1686
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos M Andreani
Phone
5491150531392
Email
jcmandreani@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22151097
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.
Results Reference
background
PubMed Identifier
8001998
Citation
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.
Results Reference
background
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
25322688
Citation
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.
Results Reference
background
PubMed Identifier
19268842
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.
Results Reference
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Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy

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