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

Not Applicable

Not yet recruiting

• Conditions: Spasticity; Cerebral Palsy
• Interventions: Device: Lateral spinal cord surgical implant of electrodes

• Registration Number: NCT02199015
• Lead Sponsor: Juan Carlos M. Andreani MD

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).

Study Timeline

• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Study Start: 2025-06-01
• Primary Completion: 2027-04-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spasticity, Cerebral Palsy	Lateral spinal cord surgical implant of electrodes	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.

Primary Outcome Measures

Name	Time	Method
Ashworth Scale	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

Secondary Outcome Measures

Name	Time	Method
Barthel Index	Day 0 baseline evaluation. One post operative evaluation every 30 day during six months	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

Trial Locations

Locations (2)

Klinikummagdeburg; 🇩🇪 Magdeburg, Germany

Provincial Program of Neuromodulation; 🇦🇷 La Plata, Buenos Aires, Argentina