Spastic Cerebral PalsyPhase 2/3NCT03676439
Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy
A Phase 2/3 study testing Magnetic Spinal Stimulation in people with Spastic Cerebral Palsy and Dysarthria, run by Sociedad Argenttina de Neuromodulación at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Spastic Cerebral Palsy, Dysarthria
- What is being tested?
- Magnetic Spinal Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 18 Nov 2024to 26 Mar 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Chronic skin ulcers
- Drug addiction.
- Episodes of Status Epileptucus
- Personal history, or in close relatives, of medical legal complaint
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Centro de Rehabilitación San Juan de Dios
Hurlingham, Buenos Aires, 1686
Juan Carlos M Andreani, 5491150531392, jcmandreani@gmail.com
About this study
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.
Read more
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
Read the 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
- Being tested
- Magnetic Spinal Stimulation
- Keywords
- Lateral Cord Stimulation, Disability, Magnetic Stimulation, Spasticity, Spinal Cord Stimulation
- Medical subject headings
- Cerebral Palsy, Dysarthria, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Spinal StimulationDevice
Also called Neuromodulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Magnetic Spinal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: One pre interventional and monthly - up to three months - post interventional
Secondary outcomes (1)
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
Measured: One pre interventional and monthly - up to three months - post interventional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start18 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A comparision, Randomized and double blinded study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Argenttina de Neuromodulación
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital "San Juan de Dios" - Hurlingham - Argentina, Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina
- Responsible party
- Principal investigator, Juan Carlos M. Andreani MD, Sociedad Argenttina de Neuromodulación
- Investigators
- Juan Carlos M Andreani, MD, Study director, CENIT Foundation & Sociedad Argentina de NeuromodulaciónWerner Braunsdorf, MD, Principal investigator, Klinik von Magdeburg - GermanyWojciech Maksymowicz, MD, Principal investigator, University of Warmia and Mazury in Olsztyn- PolandTommaso Tufo, MD, Principal investigator, Policlinico A. Gemelli University Hospital Foundation - Rome - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676439
- Sponsor's protocol ID
- Andreani, JCM 3
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2018
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22151097Abdeen 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.
PubMed 8001998Andreani, 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.
PubMed 25322688Lefaucheur 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.
PubMed 19268842
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy - Multicenter Double Blind Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT03676439
- Acronym / sponsor ID
- Andreani, JCM 3
- Conditions
- Spastic Cerebral Palsy, Dysarthria
- Keywords
- Lateral Cord Stimulation, Disability, Magnetic Stimulation, Spasticity, Spinal Cord Stimulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sociedad Argenttina de NeuromodulaciónUniversity, hospital or other
- Collaborators
- Hospital "San Juan de Dios" - Hurlingham - Argentina, Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina
- Study start
- 18 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A comparision, Randomized and double blinded study
| Arm | Type | Receives |
|---|---|---|
| Treated Arm: Magnetic Spinal Stimulation plus PKT | Active comparator | Device: Magnetic Spinal StimulationThree 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. |
| Sham comparator | Placebo comparator | Device: Magnetic Spinal StimulationThey 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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Spinal StimulationAlso: NeuromodulationSpinal 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. | Device | Sham comparator, Treated Arm: Magnetic Spinal Stimulation plus PKT |
Primary outcome
Changes in Modified Ashworth Scale (MAS)
Time frame: One pre interventional and monthly - up to three months - post interventional
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.
Time frame: One pre interventional and monthly - up to three months - post interventional
The FIM measures what an individual can perform - Only the ability for communication, comprehension and expression, will be evaluated to assess speech changes
1 secondary outcome
Changes in Barthel's Scale
Time frame: One pre interventional and monthly - up to three months - post interventional
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 22151097Andreani 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.
- Background: PubMed 8001998Abdeen 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.
- BackgroundAndreani, 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.
- BackgroundDuchenne 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: PubMed 25322688Koy 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.
- Background: PubMed 19268842Lefaucheur 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.
Related trials for Spastic Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Carlos M Andreani, MD study director
CENIT Foundation & Sociedad Argentina de Neuromodulación
Werner Braunsdorf, MD principal investigator
Klinik von Magdeburg - Germany
Wojciech Maksymowicz, MD principal investigator
University of Warmia and Mazury in Olsztyn- Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnetic Spinal Stimulation in people with Spastic Cerebral Palsy and Dysarthria, run by Sociedad Argenttina de Neuromodulación at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos M Andreani, MD (0111550531392, jcmandreani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Modified Ashworth Scale (MAS) (time frame: One pre interventional and monthly - up to three months - post interventional). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676439, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.