Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorJuan Carlos M. Andreani MD
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged sixteen or older
Spastic Cerebral Palsy with stable condition
Motor disability unilateral or predominantly unilateral.
Troubles of speech clinically evident.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Lateral spinal cord surgical implant of electrodes
DeviceThe 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).
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Spasticity, Cerebral PalsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ashworth Scale
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
Time frame
Day 0 baseline evaluation. One post operative evaluation every 30 day during six monthsSecondary outcomes
1
Barthel Index
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
Time frame
Day 0 baseline evaluation. One post operative evaluation every 30 day during six monthsOther outcomes
1
Functional Independence Measure (FIM)- for speech
It is global independence assessment. In this case, we are going to take only those related to speech for disartria´s evaluation
Time frame
Day 0 baseline evaluation. One post operative evaluation every 30 day during six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Juan Carlos M. Andreani MD
Lead sponsor
Sociedad Argenttina de Neuromodulación
Sponsor institution
Fundación CENIT
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: