Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-22 @ 2:15 PM
NCT ID:
NCT06847295
Description:
The study will share de-identified individual participant data (IPD) that underlies all published results. Shared IPD will include baseline demographic data, detailed clinical outcomes (e.g., FMA-LE and BMCA VRI scores), secondary outcome measures (balance, ambulation, spasticity, pain levels, bladder/bowel function, quality of life, and mood assessments), and neurophysiological data such as surface electromyography recordings and video documentation. This comprehensive dataset will be made available upon reasonable request via a secure, password-protected repository, enabling replication and further research. All data will be anonymized in compliance with applicable privacy regulations to ensure participant confidentiality and data integrity.
Study:
NCT06847295
Study Brief:
Epidural Electrical Stimulation to Restore Standing and Walking in Patients With Chronic Paralysis Due to Spinal Cord Injury: A Study on Motor Recovery, Spasticity Reduction, and Quality of Life Improvement Through Neuromodulation and Intensive Rehabilitation