Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.
Disorder of Consciousness (DOC) is a highly significant and concerning consequence that frequently ensues various acute brain injuries. The DOC encompasses coma, unresponsive wakefulness syndrome (UWS), also known as persistent vegetative state (PVS), and minimally conscious state (MCS). Currently, the available treatments for arousing patients with DOC are relatively limited, encompassing pharmacotherapy, hyperbaric oxygen therapy, neuromodulation, physical rehabilitation exercises, and traditional Chinese acupuncture. Among these approaches, only amantadine and transcranial direct current stimulation have demonstrated efficacy in DOC patients; however, further extensive validation is still warranted. In recent years, spinal cord stimulation (SCS) has emerged as a cutting-edge and extensively researched modality for arousal therapy. SCS is a form of neuromodulation therapy primarily utilized for intractable pain, diabetic neuropathy, and muscle spasticity, the therapeutic efficacy of the SCS is both significant and safe. Although preliminary studies have demonstrated the potential of SCS in promoting arousal in patients with DOC, these findings are currently limited to small sample reports. Therefore, this multicenter randomized controlled trial aims to provide robust evidence on the effectiveness of SCS in promoting arousal among patients with DOC, thereby standardizing its clinical application and offering advanced evidence-based medicine for DOC management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Participants will accept the SCS stimulus for six months
Sham stimulation will be performed in the first three months after surgery, and SCS stimulation will be started in the fourth month after surgery
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGXiangya Hospital,Central South University
Changsha, Hunan, China
RECRUITINGDepartment of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGEffective 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 operation
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-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.
Time frame: 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.
Time frame: 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
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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-stimulation
The difference of effective rate of awakening between SCS group and Sham group by SECONDs scale
Time frame: 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
Time frame: SCS stimulation for 6-month-postoperative-stimulation
The difference of effective rate of awakening between SCS group and Sham group by SECONDs scale
Time frame: SCS stimulation for 6-month-postoperative-stimulation
The difference of recovery trajectories of consciousness level between SCS group and Sham group
Time frame: 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
Time frame: 6-month-postoperation