Evaluating spinal cord stimulation for patients with disorders of consciousness

Efficacy and Safety of Spinal Cord Stimulation in Patients With Disorders of Consciousness: A Multicenter, Double-blind, Randomized Controlled Trail

This study is testing whether spinal cord stimulation can help people with disorders of consciousness from brain injuries become more alert and aware.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 3 sites (Fuzhou, Fujian and 2 other locations)
• Trial ID: NCT06515132 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who have been diagnosed with DOC for 3 months to 1 year due to specific brain injuries.

Not a fit: Patients with DOC due to causes other than traumatic brain injury, hypertensive intracerebral hemorrhage, or severe cerebral infarction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve arousal and quality of life for patients with disorders of consciousness.

How similar studies have performed: Preliminary studies have shown potential success with spinal cord stimulation in promoting arousal in DOC patients, but this trial aims to provide more extensive validation.

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.

Where this trial is running

Fuzhou, Fujian and 2 other locations

• 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.

Conditions Disorder of Consciousness; Spinal Cord Stimulation; Randomized clinical trail