Short-term spinal cord stimulation for consciousness loss after brain bleeding

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 who have had a disorder of consciousness for more than 28 days after surgery for bleeding in the brain.

Age

18 to 65 years

Sex

All sexes can join.

Disease stage

Disorder of consciousness for more than 28 days after surgery for cerebral hemorrhage. The CRS-R score must meet the diagnosis of minimally conscious state (MCS).

Main reasons for not taking part

• Brain injury caused by arteriovenous malformation, cerebral aneurysm, cavernous hemangioma, brain tumor or carbon monoxide poisoning
• History of epileptic seizures
• Critical condition, unstable condition inside the skull, or risk of rebleeding
• Unstable vital signs that need mechanical ventilation
• Contraindications for spinal cord surgery

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 65 years old?YesNo

What the trial wants to find out

Disorders of consciousness (DOC) refers to the persistent loss of consciousness after 28 days in patients with brain injury caused by trauma, stroke, or hypoxia. It includes coma, vegetative state, and minimally conscious state. At present, there is no effective treatment for DOC. Only one RCT study of amantadine has proved that it may be effective for the treatment of DOC. In recent years, more evidence has shown that neuromodulation technology is beneficial to the recovery of DOC. Cervical spinal cord stimulation surgery is a new treatment method for patients with DOC. Electrodes are implanted in the high cervical spinal cord C2-C5. By adjusting different electrical stimulation parameters, it has a wake-promoting effect. In this study, patients were selected into the spinal cord stimulation group and the conventional treatment group according to the wishes of their families. The patients in the spinal cord stimulation group were given 21 days of cervical spinal cord stimulation treatment on the basis of conventional brain rehabilitation. Patients were followed up routinely and completed designated examinations at 12 months to determine the safety and efficacy of cervical spinal cord stimulation therapy.

The 2 groups in the trial

• Spinal cord electrical stimulation groupTreatment being tested

  According to the EDC system, patients are randomly assigned to receive 21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.

  Treatment: SCS

• Conventional treatment groupSham treatment, for comparison

  According to the EDC system, patients are randomly assigned to receive only routine brain resuscitation and rehabilitation awakening treatment.

  Treatment: Conventional