Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy (Andreani1)

April 24, 2026 updated by: Juan Carlos M. Andreani MD

Lateral Cord Electrical Stimulation Can Improve Spasticity in Chronic Spastic Cerebral Palsy

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1045
        • Provincial Program of Neuromodulation
  • Germany
      • Magdeburg, Germany, 399130
        • Klinikummagdeburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Implant of Neurostimulators (electrical generators)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 baseline evaluation. One post operative evaluation every 30 day during six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 baseline evaluation. One post operative evaluation every 30 day during six months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 baseline evaluation. One post operative evaluation every 30 day during six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan Carlos M. Andreani MD

Collaborators

Fundación CENIT

Investigators

  • Principal Investigator: Werner Braunsdorf, MD, Klinik von Magdeburg - Germany
  • Study Director: Juan Carlos Andreani, MD, Sociedad Argentina de Neuromodulación

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2027

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimated)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Andreani, JCM 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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