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

NCT02199015 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Andreani, JCM 1
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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

Conditions

Spasticity; Cerebral Palsy

Keywords

Dysarthria; Electrical Stimulation; Lateral Cord Stimulation; Spasticity; Treatment

Outcome Measures

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

  Day 0 baseline evaluation. One post operative evaluation every 30 day during six months

Secondary Outcomes (1)

• Barthel Index

  Day 0 baseline evaluation. One post operative evaluation every 30 day during six months

Other Outcomes (1)

• Functional Independence Measure (FIM)- for speech

  Day 0 baseline evaluation. One post operative evaluation every 30 day during six months

Study Arms (1)

Spasticity, Cerebral Palsy

EXPERIMENTAL

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

Interventions

Lateral spinal cord surgical implant of electrodes DEVICE

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).

Also known as: Implant of Neurostimulators (electrical generators)

Spasticity, Cerebral Palsy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juan Carlos M. Andreani MD: lead
• Fundación CENIT: collaborator

Study Sites (2)

Provincial Program of Neuromodulation

La Plata, Buenos Aires, 1045, Argentina

Location

Klinikummagdeburg

Magdeburg, 399130, Germany

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Dysarthria

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations

Study Officials

• Juan Carlos Andreani, MD

  Sociedad Argentina de Neuromodulación

  STUDY DIRECTOR

• Werner Braunsdorf, MD

  Klinik von Magdeburg - Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Carlos Andreani, MD

CONTACT

5491150531392; jcmandreani@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 24, 2014
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); AR (1)