Clinical trial NCT02199015: Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy
Official title: Lateral Cord Electrical Stimulation Can Improve Spasticity in Chronic Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Spasticity
Keywords: Dysarthria
Electrical Stimulation
Lateral Cord Stimulation
Spasticity
Treatment
Lead sponsor: Sociedad Argenttina de Neuromodulación
Sponsor class: OTHER
Collaborators: name: Fundación CENIT
First posted: 2014-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Ashworth Scale
timeFrame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
Secondary outcomes:
measure: Barthel Index
timeFrame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
Other outcomes:
measure: Functional Independence Measure (FIM)- for speech
timeFrame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
Locations:
city: La Plata
country: Argentina
facility: Provincial Program of Neuromodulation
state: Buenos Aires
city: Magdeburg
country: Germany
facility: Klinikummagdeburg
Study officials:
affiliation: Sociedad Argentina de Neuromodulación
name: Juan Carlos Andreani, MD
role: STUDY_DIRECTOR
affiliation: Klinik von Magdeburg - Germany
name: Werner Braunsdorf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.