Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
NCT Number: NCT06515132
Acronym: SCORS-DOC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Disorder of Consciousness|Spinal Cord Stimulation
Interventions: PROCEDURE: SCS Stimulation|PROCEDURE: Sham Stimulation
Sponsor: Huashan Hospital
Collaborators: Xiangya Hospital of Central South University|First Affiliated Hospital of Fujian Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-05-30

Summary:
Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.

Primary Outcome Measures: Effective rate of awakening, The CRS-R is employed, with a minimum of 5 CRS-R assessments conducted at each follow-up time point, accompanied by simultaneous video recording. And the highest value is scored as a state of consciousness. The clinical assessment of participants' consciousness is deemed significantly improved when it fulfills the following criteria: a) MCS- recover to consciousness level of MCS+ or higher; b) MCS status (MCS- or MCS+) recover to emergence from MCS (restoration of functional communication)., SCS stimulation for 3 months after operation
Secondary Outcome Measures: The difference of CRS-R scale relative to baseline between SCS group and Sham group, The Coma Recovery Scale-Revised (CRS-R) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. It has good validity, reliability and practicability., SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation|The difference of SECONDs scale relative to baseline between SCS group and Sham group, The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a fast tool to assess consciousness in brain-injured patients., SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation|The difference of modified Ashworth scale relative to baseline between SCS group and Sham group, The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone., SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation|The NCS-R scale relative to baseline between SCS group and Sham group, The Nociception Coma Scale-Revised (NCS-R) was developed to help assess pain in patients with disorders of consciousness (DOC). Several studies have shown its sensitivity in assessing response to acute noxious stimuli., SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation|The difference of effective rate of awakening between SCS group and Sham group by SECONDs scale, SCS stimulation for 3-month-postoperative-stimulation|SCS stimulation for 6-month-postoperative-stimulation, the difference of effective rate of awakening between SCS group and Sham group by CRS-R scale, SCS stimulation for 6-month-postoperative-stimulation|The difference of effective rate of awakening between SCS group and Sham group by SECONDs scale, SCS stimulation for 6-month-postoperative-stimulation|The difference of recovery trajectories of consciousness level between SCS group and Sham group, SCS stimulation for 6-month-postoperative-stimulation|The difference of effective rate of awakening of 3 month s of sham stimulation and 3 month s of SCS stimulation in Sham group, 6-month-postoperation
Other Outcome Measures: Security outcome, Incidence of postoperative infections within 3 months after operation, 3 months after operation|Security outcome, Incidence of postoperative hemorrhage within 3 months after operation, 3 months after operation