Clinical trial NCT06515132: Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
Official title: Efficacy and Safety of Spinal Cord Stimulation in Patients With Disorders of Consciousness: A Multicenter, Double-blind, Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorder of Consciousness
Spinal Cord Stimulation
Keywords: Disorder of Consciousness
Spinal Cord Stimulation
Randomized clinical trail
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Xiangya Hospital of Central South University
name: First Affiliated Hospital of Fujian Medical University
First posted: 2024-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).
* The vital signs and state of consciousness are stable: normal body temperature, the spontaneous breathing is stable (minimal sputum production and respiratory stability without oxygen supplementation for at least 2 hours); there is no significant change in the level of consciousness for at least 1 month and more.
* Presence of short-latency responses (N20/P25) on somatosensory evoked potentials (SEP) recorded from the median nerve in the upper limbs.
* Written informed consent obtained from legal guardians or representatives.

Exclusion Criteria:

* 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;
* Patients with brainstem hemorrhage;
* Pregnant women;
* Patients who voluntarily request SCS implantation but are unwilling to cooperate with the research protocol;
* Participants in other clinical trials.

Primary outcomes:
measure: Effective rate of awakening
timeFrame: SCS stimulation for 3 months after operation
Secondary outcomes:
measure: The difference of CRS-R scale relative to baseline between SCS group and Sham group
timeFrame: SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation
measure: The difference of SECONDs scale relative to baseline between SCS group and Sham group
timeFrame: SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation
measure: The difference of modified Ashworth scale relative to baseline between SCS group and Sham group
timeFrame: SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation
measure: The NCS-R scale relative to baseline between SCS group and Sham group
timeFrame: SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation
measure: The difference of effective rate of awakening between SCS group and Sham group by SECONDs scale
timeFrame: SCS stimulation for 3-month-postoperative-stimulation
measure: SCS stimulation for 6-month-postoperative-stimulation, the difference of effective rate of awakening between SCS group and Sham group by CRS-R scale
timeFrame: SCS stimulation for 6-month-postoperative-stimulation
measure: The difference of effective rate of awakening between SCS group and Sham group by SECONDs scale
timeFrame: SCS stimulation for 6-month-postoperative-stimulation
measure: The difference of recovery trajectories of consciousness level between SCS group and Sham group
timeFrame: SCS stimulation for 6-month-postoperative-stimulation
measure: The difference of effective rate of awakening of 3 month s of sham stimulation and 3 month s of SCS stimulation in Sham group
timeFrame: 6-month-postoperation
Other outcomes:
measure: Security outcome
timeFrame: 3 months after operation
measure: Security outcome
timeFrame: 3 months after operation
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Changsha
country: China
facility: Xiangya Hospital,Central South University
state: Hunan
city: Shanghai
country: China
facility: Department of Neurosurgery, Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Neurosurgery, Huashan Hospital, Fudan University
name: Xuehai Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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