Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHuashan Hospital
About this trial
Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients between the ages of 18 and 65, experiencing DOC for a duration ranging from 3 months to 1 year following brain disease.
Patients diagnosed with DOC as a consequence of traumatic brain injury, hypertensive intracerebral hemorrhage, or severe cerebral infarction.
Patients exhibiting stable cerebral anatomy and no need for further cranioplasty or hydrocephalus shunt.
Patients in MCS, who fulfill at least one of the following criteria: ① Demonstrating an oriented response to noxious stimuli; ② Exhibiting sustained eye tracking behavior; ③ Displaying purposeful movements; ④ Manifesting comprehension of language or emotions and actions (often observed in specific environments such as when hearing family members crying).
Disqualifiers
Patients with a history of severe neurological or psychiatric disorders, or other significant diseases impacting prognosis prior to the onset of DOC;
Patients with contraindications for surgery, such as acute infections or coagulation disorders;
Patients who require short-wave diathermy treatment and are unable to undergo neurostimulation;
Patients with hypoxic brain injury due to suffocation, cardiac arrest, or respiratory arrest;
Trial design
Design model
Parallel
Treatments tested in this trial
SCS Stimulation
Procedure/SurgeryParticipants will accept the SCS stimulus for six months
Sham Stimulation
Procedure/SurgerySham stimulation will be performed in the first three months after surgery, and SCS stimulation will be started in the fourth month after surgery
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: SCS groupExperimental treatment 1 intervention
Group B: Sham groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
SCS stimulation for 3 months after operationSecondary outcomes
1
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.
Time frame
SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation2
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.
Time frame
SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation3
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.
Time frame
SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation4
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.
Time frame
SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulationOther outcomes
1
Security outcome
Incidence of postoperative infections within 3 months after operation
Time frame
3 months after operation2
Security outcome
Incidence of postoperative hemorrhage within 3 months after operation
Time frame
3 months after operationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Huashan Hospital
Lead sponsor
Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Source ClinicalTrials.gov