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Not yet recruiting NCT02199015

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

No phase Interventional Cerebral Palsy Spasticity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lateral spinal cord surgical implant of electrodes.
Who it may be relevant to
Registry conditions: Cerebral Palsy, Spasticity. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Argentina, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • 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).

Primary outcome measures

  • Ashworth Scale [Time frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months]
Secondary outcome measures (1)
  • Barthel Index [Time frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Argentina · 1 center
  • Provincial Program of Neuromodulation — La Plata
Germany · 1 center
  • Klinikummagdeburg — Magdeburg

Publications

  • 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. PMID 22151096
  • 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. PMID 22151097

Identifiers

NCT: NCT02199015 · Andreani, JCM 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗