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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
Sponsor:
Collaborator:
Fundación CENIT
Information provided by (Responsible Party):
Juan Carlos M. Andreani MD, Sociedad Argenttina de Neuromodulación

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

Condition or disease Intervention/treatment Phase
Cerebral Palsy Spasticity Device: Lateral spinal cord surgical implant of electrodes Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: Juan Carlos Andreani, MD 5491150531392 jcmandreani@gmail.com

Locations
Argentina
Provincial Program of Neuromodulation Active, not recruiting
La Plata, Buenos Aires, Argentina, 1045
Germany
Klinikummagdeburg Active, not recruiting
Magdeburg, Germany, 399130
Sponsors and Collaborators
Juan Carlos M. Andreani MD
Fundación CENIT
Investigators
Study Director: Juan Carlos Andreani, MD Sociedad Argentina de Neuromodulación
Principal Investigator: Werner Braunsdorf, MD Klinik von Magdeburg - Germany

Publications:
Responsible Party: Juan Carlos M. Andreani MD, MD, Sociedad Argenttina de Neuromodulación
ClinicalTrials.gov Identifier: NCT02199015     History of Changes
Other Study ID Numbers: Andreani, JCM 1
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes, we plan to share data as long as participants are recruited. Because there are not yet patients, we do not have data to share

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Juan Carlos M. Andreani MD, Sociedad Argenttina de Neuromodulación:
Dysarthria
Electrical Stimulation
Lateral Cord Stimulation
Spasticity
Treatment

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms