Evaluating spinal cord stimulation for patients with disorders of consciousness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of spinal cord stimulation (SCS) as a treatment for patients experiencing disorders of consciousness (DOC) resulting from acute brain injuries. The study aims to provide robust evidence through a multicenter randomized controlled trial, comparing SCS stimulation to sham stimulation in promoting arousal in patients diagnosed with conditions such as coma and minimally conscious state. By focusing on patients who have been in DOC for 3 months to 1 year, the trial seeks to standardize the clinical application of SCS and enhance evidence-based management of DOC. The study is significant as current treatment options are limited and SCS has shown promise in preliminary studies.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• Xiangya Hospital,Central South University
  Changsha, Hunan, China Recruiting
• Department of Neurosurgery, Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Xuehai Wu, Ph.D. — Department of Neurosurgery, Huashan Hospital, Fudan University
• Study coordinator: Xuehai Wu, Ph.D.
• Email: Wuxuehai2013@163.com
• Phone: +8613764880571

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.