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

Sponsor
Juan Carlos M. Andreani MD
Study ID
NCT02199015
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy
  • Spasticity

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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

Key Dates

First listed
Jul 24, 2014
Start date
Jun 1, 2027
Status verified
Apr 2026
Primary completion
Apr 1, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Ashworth Scale [ Time Frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months ]

Central Contacts

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