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Tests treatment safety and results for Disorder of Consciousness
Official title Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation
ClinicalTrials.gov ID: NCT06515132
What this study is testing
- What it's testing
- Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- The vital signs and state of consciousness are stable: normal body temperature, the spontaneous breathing is stable (minimal sputum production and...
You likely can't join if
- 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;
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Changsha, Hunan, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.