Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy (Andreani1)

Juan Carlos M. Andreani MD

Status: Not yet enrolling

Conditions: Spasticity; Cerebral Palsy

Treatments: Device: Lateral spinal cord surgical implant of electrodes

Study type: Interventional

Funder types: Other

Identifiers

NCT02199015

Andreani, JCM 1

Details and patient eligibility

About

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

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Spasticity, Cerebral Palsy

Experimental group

Description:

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.

Treatment:

Device: Lateral spinal cord surgical implant of electrodes