Cerebral PalsyAndreani1NCT02199015
Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy
A study testing Lateral spinal cord surgical implant of electrodes in people with Cerebral Palsy and Spasticity, run by Juan Carlos M. Andreani MD at 2 sites in 2 countries.
Trial summary
The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS) causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing spasticity and the spastic syndrome in selected cases of patients with cerebral palsy Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cerebral Palsy, Spasticity
- What is being tested?
- Lateral spinal cord surgical implant of electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2027to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged sixteen or older
- Spastic Cerebral Palsy with stable condition
- Motor disability unilateral or predominantly unilateral.
- Troubles of speech clinically evident.
- Normal or Slightly sub-normal I.Q
- No psychiatric disorders.
Who cannot join
- Severe cardiac or respiratory troubles
- Fixed abnormal postures (except if previously corrected by orthopedic surgery)
- Chronic recurrent bronchial or pulmonary infections
- Chronic recurrent urinary infections
- Severe osteoporosis on affected limbs
- Chronic skin ulcerations.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Argentina1 site
Provincial Program of Neuromodulation
La Plata, Buenos Aires, 1045
About this study
Official title: Lateral Cord Electrical Stimulation Can Improve Spasticity in Chronic Spastic Cerebral Palsy
The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS) causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing spasticity and the spastic syndrome in selected cases of patients with cerebral palsy
Read the detailed description
PROJECT Lateral Cord Stimulation was thought by the author to be employed in patients with spastic cerebral palsy with the aim to improve tonus, motor function and speech.
Nevertheless, as it has been demonstrated as acting on the basic phenomena related with spasticity, it's to say the propagated spinal responses, its use could be extended to other forms of spastic disease, like spastic limbs post stroke, brain congenital malformations producing spasticity and motor disorders as the main signs, post anoxic encephalopathy, etc.
In this preliminary clinical trial, classed as phase 3, our sample must be very limited to assure stable conditions for statistical significance, hence our group is going to be circumscribed to certain conditions and pathology.
In the future, as long the method could spread its use, the extension on indications in other pathological conditions is advisable thus, its possibilities of marketing could be enlarged with its use in a broader spectrum of spastic patients.
Calculated risks are similar to those related with the ancient surgical technique called "Scoville"technique, currently employed time ago for cervical discectomy (6) Investigational plan The purpose of this clinical trial is to release spasticity and by this means improve the condition of patients with spastic cerebral palsy by extradural lateral cord electrical stimulation, by using currently employed electrodes and neurostimulators Those devices are already FDA approved and currently used for Dorsal Column Stimulation with the objective to treat chronic Pain and spasticity (Spasmodic Torticollis).
- Conditions
- Cerebral Palsy, Spasticity
- Being tested
- Lateral spinal cord surgical implant of electrodes
- Keywords
- Dysarthria, Electrical Stimulation, Lateral Cord Stimulation, Spasticity, Treatment
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral spinal cord surgical implant of electrodesDevice
Also called Implant of Neurostimulators (electrical generators)
The procedure is based on the classic approaches to posterior cervical region for herniated discs, actually not longer employed for that aim A unilateral hemilaminectomy will be performed at C3-C4 level, starting from 4th cervical spinous process.
A multicontact electrode will be placed on the lateral surface of the spinal cord that will be subcutaneusly connected to an implanted pulse generator (IPG).
| Study group | Role | What they receive |
|---|---|---|
| Spasticity, Cerebral Palsy | Experimental | To perform a Lateral spinal cord surgical implant of electrodes for electrical neuromodulation of a cohort of selectyed patients with refractory Spastic Cerebral Palsy To compare spasticity and speech trouble´s evolution on a cohort of treated patients, by evaluating their pre and post operative status into one year follow up. Receives: Device: Lateral spinal cord surgical implant of electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ashworth Scale
The Ashworth scale has 5 points, they are: 1) no increase in muscle tone; 2) slight increase giving a catch when part is moved in flexion or extension; 3) more marked increase in tone but only after part is easily flexed; 4) considerable increase in tone; and 5) passive movement is difficult and affected part is rigid in flexion or extension
Measured: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
Secondary outcomes (1)
Barthel Index
The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility of the patient. The items include feeding, moving from wheelchair,etc, and the whole evaluation is from 100 maximum what means total independence, to 0, absolute dependence
Measured: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study start1 Jun 2027 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Carlos M. Andreani MD
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación CENIT
- Responsible party
- Sponsor-investigator, Juan Carlos M. Andreani MD, Sociedad Argenttina de Neuromodulación
- Investigators
- Juan Carlos Andreani, MD, Study director, Sociedad Argentina de NeuromodulaciónWerner Braunsdorf, MD, Principal investigator, Klinik von Magdeburg - Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199015
- Sponsor's protocol ID
- Andreani, JCM 1
- Acronym
- Andreani1
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2014
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Yes, we plan to share data as long as participants are recruited. Because there are not yet patients, we do not have data to share
Publications
Andreani JC, Guma C. New animal model to mimic spastic cerebral palsy: the brain-damaged pig preparation. Neuromodulation. 2008 Jul;11(3):196-201. doi: 10.1111/j.1525-1403.2008.00166.x.
PubMed 22151096Andreani 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 22151097
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Cord Electrical Stimulation Can Improve Spasticity in Chronic Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02199015
- Acronym / sponsor ID
- Andreani1 / Andreani, JCM 1
- Conditions
- Cerebral Palsy, Spasticity
- Keywords
- Dysarthria, Electrical Stimulation, Lateral Cord Stimulation, Spasticity, Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Juan Carlos M. Andreani MDUniversity, hospital or other
- Collaborators
- Fundación CENIT
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- 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.
The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS) causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing spasticity and the spastic syndrome in selected cases of patients with cerebral palsy
Detailed description
PROJECT Lateral Cord Stimulation was thought by the author to be employed in patients with spastic cerebral palsy with the aim to improve tonus, motor function and speech.
Nevertheless, as it has been demonstrated as acting on the basic phenomena related with spasticity, it's to say the propagated spinal responses, its use could be extended to other forms of spastic disease, like spastic limbs post stroke, brain congenital malformations producing spasticity and motor disorders as the main signs, post anoxic encephalopathy, etc.
In this preliminary clinical trial, classed as phase 3, our sample must be very limited to assure stable conditions for statistical significance, hence our group is going to be circumscribed to certain conditions and pathology.
In the future, as long the method could spread its use, the extension on indications in other pathological conditions is advisable thus, its possibilities of marketing could be enlarged with its use in a broader spectrum of spastic patients.
Calculated risks are similar to those related with the ancient surgical technique called "Scoville"technique, currently employed time ago for cervical discectomy (6) Investigational plan The purpose of this clinical trial is to release spasticity and by this means improve the condition of patients with spastic cerebral palsy by extradural lateral cord electrical stimulation, by using currently employed electrodes and neurostimulators Those devices are already FDA approved and currently used for Dorsal Column Stimulation with the objective to treat chronic Pain and spasticity (Spasmodic Torticollis).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spasticity, Cerebral Palsy | Experimental | Device: Lateral spinal cord surgical implant of electrodesTo perform a Lateral spinal cord surgical implant of electrodes for electrical neuromodulation of a cohort of selectyed patients with refractory Spastic Cerebral Palsy To compare spasticity and speech trouble´s evolution on a cohort of treated patients, by evaluating their pre and post operative status into one year follow up. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Aged sixteen or older
- Spastic Cerebral Palsy with stable condition
- Motor disability unilateral or predominantly unilateral.
- Troubles of speech clinically evident.
- Normal or Slightly sub-normal I.Q
Key exclusion criteria (6 listed)
- Severe cardiac or respiratory troubles
- Fixed abnormal postures (except if previously corrected by orthopedic surgery)
- Chronic recurrent bronchial or pulmonary infections
- Chronic recurrent urinary infections
- Severe osteoporosis on affected limbs
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 |
|---|---|---|
| Lateral spinal cord surgical implant of electrodesAlso: Implant of Neurostimulators (electrical generators)The procedure is based on the classic approaches to posterior cervical region for herniated discs, actually not longer employed for that aim A unilateral hemilaminectomy will be performed at C3-C4 level, starting from 4th cervical spinous process. A multicontact electrode will be placed on the lateral surface of the spinal cord that will be subcutaneusly connected to an implanted pulse generator (IPG). | Device | Spasticity, Cerebral Palsy |
Primary outcome
Ashworth Scale
Time frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
The Ashworth scale has 5 points, they are: 1) no increase in muscle tone; 2) slight increase giving a catch when part is moved in flexion or extension; 3) more marked increase in tone but only after part is easily flexed; 4) considerable increase in tone; and 5) passive movement is difficult and affected part is rigid in flexion or extension
1 secondary outcome
Barthel Index
Time frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 22151096Andreani JC, Guma C. New animal model to mimic spastic cerebral palsy: the brain-damaged pig preparation. Neuromodulation. 2008 Jul;11(3):196-201. doi: 10.1111/j.1525-1403.2008.00166.x.
- 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.
- Individual participant dataSharing planned: Yes. Yes, we plan to share data as long as participants are recruited. Because there are not yet patients, we do not have data to share
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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.
Juan Carlos Andreani, MD study director
Sociedad Argentina de Neuromodulación
Werner Braunsdorf, MD principal investigator
Klinik von Magdeburg - Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral spinal cord surgical implant of electrodes in people with Cerebral Palsy and Spasticity, run by Juan Carlos M. Andreani MD at 2 sites in 2 countries.
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 6 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: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina, Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos Andreani, MD (5491150531392, jcmandreani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ashworth Scale (time frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months). 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 NCT02199015, which also lists 2 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 28 Apr 2026.