Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy (Andreani1)
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|ClinicalTrials.gov Identifier: NCT02199015|
Recruitment Status : Not yet recruiting
First Posted : July 24, 2014
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy Spasticity||Device: Lateral spinal cord surgical implant of electrodes||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lateral Cord Electrical Stimulation Can Improve Spasticity in Chronic Spastic Cerebral Palsy|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: Spasticity, Cerebral Palsy
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.
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).
Other Name: Implant of Neurostimulators (electrical generators)
- Ashworth Scale [ Time Frame: 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
- Barthel Index [ Time Frame: 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
- Functional Independence Measure (FIM)- for speech [ Time Frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months ]It is global independence assessment. In this case, we are going to take only those related to speech for disartria´s evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199015
|Contact: Juan Carlos Andreani, MDemail@example.com|
|Provincial Program of Neuromodulation||Active, not recruiting|
|La Plata, Buenos Aires, Argentina, 1045|
|Klinikummagdeburg||Active, not recruiting|
|Magdeburg, Germany, 399130|
|Study Director:||Juan Carlos Andreani, MD||Sociedad Argentina de Neuromodulación|
|Principal Investigator:||Werner Braunsdorf, MD||Klinik von Magdeburg - Germany|