Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy

Cerebral Palsy Clinical Trial

— Andreani1  

Official title:

Lateral Cord Electrical Stimulation Can Improve Spasticity in Chronic Spastic Cerebral Palsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02199015
• Other study ID #: Andreani, JCM 1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2025
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: Sociedad Argenttina de Neuromodulación
• Contact: Juan Carlos Andreani, MD
• Phone: 5491150531392
• Email: jcmandreani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spasticity

Intervention

Device:
• Lateral spinal cord surgical implant of electrodes
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).

Locations

Country	Name	City	State
Argentina	Provincial Program of Neuromodulation	La Plata	Buenos Aires
Germany	Klinikummagdeburg	Magdeburg

Sponsors (2)

Lead Sponsor	Collaborator
Juan Carlos M. Andreani MD	Fundación CENIT

Countries where clinical trial is conducted

Argentina,  Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Independence Measure (FIM)- for speech	It is global independence assessment. In this case, we are going to take only those related to speech for disartria´s evaluation	Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
Primary	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	Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
Secondary	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	Day 0 baseline evaluation. One post operative evaluation every 30 day during six months