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

Study acronym: Andreani1
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Apr 1, 2027 to Apr 1, 2029
    • Start date: Jun 1, 2025 to Jun 1, 2027
    • Study completion date: Dec 31, 2027 to Dec 31, 2030
    v19
  2. Primary completion date: Apr 1, 2026 to Apr 1, 2027
    • Start date: Jun 1, 2024 to Jun 1, 2025
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v18
  3. Primary completion date: Apr 1, 2024 to Apr 1, 2026
    • Start date: Jun 1, 2022 to Jun 1, 2024
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v17
  4. Primary completion date: Apr 1, 2022 to Apr 1, 2024
    • Start date: Mar 1, 2021 to Jun 1, 2022
    • Study completion date: Dec 31, 2022 to Dec 31, 2024
    v16
  5. Primary completion date: Jul 2021 to Apr 1, 2022
    • Start date: Jul 1, 2020 to Mar 1, 2021
    • Study completion date: Mar 2022 to Dec 31, 2022
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Dec 2020 to Jul 2021
    • Start date: Dec 1, 2019 to Jul 1, 2020
    v14
  2. Start date: Jul 1, 2019 to Dec 1, 2019
    • Primary completion date: Jul 2020 to Dec 2020
    • Study completion date: Sep 2021 to Mar 2022
    v13
  3. Lead sponsor: Juan Carlos M. Andreani to Juan Carlos M. Andreani MD
    • Primary completion date: Dec 2019 to Jul 2020
    • Start date: Dec 1, 2018 to Jul 1, 2019
    • Study completion date: Dec 2020 to Sep 2021
    v12
  4. Primary completion date: May 2019 to Dec 2019
    • Start date: Mar 1, 2018 to Dec 1, 2018
    • Study completion date: May 2020 to Dec 2020
    v11
  5. Start date: Nov 1, 2017 to Mar 1, 2018v10
  6. Re-verified, no change to tracked fieldsv9
  7. Phase: Phase 2/3 to Not applicable
    • Primary completion date: May 2018 to May 2019
    • Start date: May 2017 to Nov 1, 2017
    • Study completion date: Jul 2019 to May 2020
    v8
  8. Re-verified, no change to tracked fieldsv7
  9. Trial status: Enrolling by Invitation to Not Yet Recruitingv6
  10. Start date: Mar 2017 to May 2017
    • Primary completion date: Mar 2018 to May 2018
    • Study completion date: May 2019 to Jul 2019
    v5
  11. Collaborators expanded, about 2 wordsv4
  12. Re-verified, no change to tracked fieldsv3
  13. Phase: Phase 3 to Phase 2/3v2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date: Oct 2016 to Mar 2017
    • Primary completion date: Oct 2017 to Mar 2018
    • Study completion date: Dec 2018 to May 2019
    • Interventions: Surgical spinal implant of electrodes on Lateral surface of the spinal cord (Device) to Lateral spinal cord surgical implant of electrodes (Device)
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT02199015
Lead Sponsor Juan Carlos M. Andreani MD
Collaborators: Fundación CENIT
Conditions
(from sponsor)		 Cerebral Palsy, Spasticity
Related terms Cerebral Palsy, Dysarthria, Muscle Spasticity
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov