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

NCT ID: NCT02199015

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-12-31

Brief 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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spasticity, Cerebral Palsy

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.

Group Type: EXPERIMENTAL

Lateral spinal cord surgical implant of electrodes

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Implant of Neurostimulators (electrical generators)

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación CENIT

UNKNOWN

Sponsor Role: collaborator

Juan Carlos M. Andreani MD

OTHER

Sponsor Role: lead

Responsible Party

Juan Carlos M. Andreani MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Juan Carlos Andreani, MD

Role: STUDY_DIRECTOR

Sociedad Argentina de Neuromodulación

Werner Braunsdorf, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik von Magdeburg - Germany

Locations

Provincial Program of Neuromodulation

La Plata, Buenos Aires, Argentina

Klinikummagdeburg

Magdeburg, , Germany

Countries

Argentina; Germany

Central Contacts

Juan Carlos Andreani, MD

Role: CONTACT

jcmandreani@gmail.com

5491150531392

References

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.

Reference Type: BACKGROUND

PMID: 22151096 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22151097 (View on PubMed)

Other Identifiers

Andreani, JCM 1

Identifier Type: -

Identifier Source: org_study_id