NCT07730099尚未招募不适用
Cognitive Network Restoration Therapy for Moderate to Severe Traumatic Brain Injury: A Feasibility Study
ReEmerge, Inc.0 个研究点目标入组 40 人开始时间: 2027年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Device and Procedure Safety
研究概览
简要总结
The purpose of this feasibility clinical investigation is to evaluate the safety and usability of central thalamic deep brain stimulation (CT-DBS) for use in patients with chronic moderate to severe traumatic brain injury (TBI) and to explore its potential effects on cognitive and functional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of moderate to severe TBI based on estimated worst Glasgow Coma Scale (GCS) score within first 48 hours of injury (acceptable GCS range = 3-12)
- •Age ≥18 and <75 years at the time of informed consent.
- •At least 24 months from date of TBI injury
- •Fluent in local language and able to independently provide consent
- •Rating of upper moderate disability to lower good recovery on the Glasgow Outcome Scale-Extended (GOSE) at time of enrollment (acceptable GOSE range 5-7)
- •Failure to return to pre-injury level of vocational or educational function
- •Either receiving no CNS stimulants or other medications known to affect cognitive function, or on stable doses of these medications for at least last three months prior to signing consent.
排除标准
- •History of major developmental, neurologic, psychiatric or substance use disorder with evidence of disability prior to onset of TBI
- •Any DSM-5 personality disorder diagnosis, as determined by SCID-5-PD, will exclude the participant.
- •Major medical co-morbidities: end stage renal failure, heart failure, severe congestive heart disease, coagulopathy, severe respiratory problems, liver failure, uncontrolled hypertension or other significant medical co-morbidities.
- •Receiving anti-epileptic medications to control active seizures
- •Have had a documented seizure within 3 months prior to signing consent
- •Malignancy with < 5 years life expectancy.
- •Untreated / uncontrolled (severe at the time of enrollment) depression or other psychiatric disorder.
- •Women of childbearing age who do not regularly use an accepted contraceptive method. Participants who become pregnant after enrollment may be excluded from the study. Those who become pregnant prior to the surgical implantation of the DBS system will be excluded from the study.
- •Inability to stop Coumadin or platelet anti-aggregation therapy before, during and after surgery.
- •Previous DBS or other brain implants
- •Previous ablative intracranial surgery
- •Implantable hardware not compatible with MRI or unwilling to undergo MRI (e.g. claustrophobia)
- •Condition requiring diathermy after DBS implantation
- •Hardware, lesions or other factors limiting placement of electrodes in optimal target location in the judgment of the implanting surgeon
- •Concurrent enrollment in any other clinical trial
- •Any condition that, in the judgment of the PI, significantly increases risk or significantly reduces the likelihood of benefit from DBS
结局指标
主要结局
Device and Procedure Safety
时间窗: Implant through Day 90 after stimulation activation.
Proportion of participants experiencing at least one device or procedure related serious adverse event (SAE) from implantation through Day 90 after stimulation activation, including events such as intracranial hemorrhage, infection requiring explant or IV antibiotics, lead or hardware complications requiring surgical intervention, or other SAEs judged related to the DBS system, implantation procedure, or stimulation therapy.
次要结局
- Overall Safety(Implant through Day 90 after stimulation activation.)
研究者
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