NCT02199015

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Juan Carlos M. Andreani MD · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-04-01
• Completion: 2027-12-31
• First posted: 2014-07-24
• Last updated: 2023-11-21

Locations

2 sites across 2 countries: Argentina, Germany

Regulatory

• FDA-regulated device study