CT-DBS for Traumatic Brain Injury Using the Medtronic Activa PC+S System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Percent Change in Trail Making Test Part B Time to Completion
研究概览
简要总结
This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation. Although all patients will receive stimulation continuously through a surgically implanted pacemaker-like device, half of the patients will have the device deactivated during a blinded assessment phase. The device will be reactivated following this assessment and patients will have the option to continue stimulation in an open-label continuation.
详细描述
This preliminary safety study evaluates the use of the Medtronic Activa PC+S system and Medtronic Nexus-E system for central thalamic deep brain stimulation (CT-DBS) in the treatment of cognitive impairment secondary to traumatic brain injury (TBI). It involves a neurosurgical procedure in which electrodes are implanted in the brain, connected to an implanted pacemaker-like device in the chest. The proposed study, if successful, will provide supporting evidence for the development of a novel therapeutic approach utilizing CT-DBS to improve these enduring cognitive impairments arising in persons with multi-focal structural brain injuries. This research will address the critical gap of the lack of any available treatments. CT-DBS targets well-defined neuronal populations within the central thalamus that have known anatomical and physiological specializations, which not only provide a key role in arousal regulation during cognitively-mediated behaviors, but also exhibit a particular vulnerability to dysfunction in the setting of multi-focal, non-selective brain injuries.
Our proposed study aims to support development of CT-DBS as a novel therapeutic avenue for accessing cognitive reserve in patients with acquired brain injuries. In the proposed feasibility study of 6 subjects at a single investigational site, we will test the safety of CT-DBS in the severe traumatic brain injury (STBI) population with GOSE 6-7 level recovery and collect data to establish the translation of preclinical studies into human application of CT-DBS.
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
- 22 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of moderate to severe TBI based on worst GCS score within first 48 hours of injury (acceptable GCS range = 3-12)
- •Age 22-60
- •At least 24 months from date of onset
- •Fluent in English 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 the last three months
排除标准
- •History of major developmental, neurologic, psychiatric or substance use disorder with evidence of disability prior to onset of TBI
- •Major medical co-morbidities including: end stage renal failure, severe heart failure, coagulopathy, severe respiratory problems, severe liver failure, uncontrolled hypertension or other significant medical co morbidities
- •Have had a documented seizure within 3 months of study screening (subjects may re-screen if seizure free after initial screen failure)
- •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
- •Inability to stop anticoagulation therapy 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
- •Condition requiring diathermy after DBS implantation
- •Hardware, lesions or other factors limiting placement of electrodes in optimal target location in the judgment of the operating surgeon
- •Concurrent enrollment in any other clinical trial
- •Any condition or finding 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
Percent Change in Trail Making Test Part B Time to Completion
时间窗: Pre-surgery baseline to treatment phase end (up to 197 days)
The Trail Making Test is a measure of attention, speed and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task. Lower scores (shorter times) correspond to a better outcome.
次要结局
- Percent Change in Trail Making Test Part A Time to Completion(Pre-surgery baseline to treatment phase end (up to 197 days))
- Percent Change in Traumatic Brain Injury Quality of Life - Executive Function Short Form (TBI-QOL) Scale Score(Pre-surgery baseline to treatment phase end (up to 197 days))
- Percent Change Traumatic Brain Injury Quality of Life - Attention/Concentration Short Form Scale Score(Pre-surgery baseline to treatment phase end (up to 197 days))
- Percent Change in Ruff 2 and 7 Automatic Detection Speed Score(Pre-surgery baseline to treatment phase end (up to 197 days))
- Percent Change in Traumatic Brain Injury Quality of Life - Fatigue Short Form Scale Score(Pre-surgery baseline to treatment phase end (up to 197 days))
- Percent Change in Rivermead Post-Concussion Symptom Questionnaire Scale Score(Pre-surgery baseline to treatment phase end (up to 197 days))
- Percent Change in Ruff 2 and 7 Automatic Detection Accuracy Score(Pre-surgery baseline to treatment phase end (up to 197 days))
- Percent Change in Ruff 2 and 7 Controlled Search Accuracy Score(Pre-surgery baseline to treatment phase end (up to 197 days))
- Percent Change in Ruff 2 and 7 Controlled Search Speed Score(Pre-surgery baseline to treatment phase end (up to 197 days))
- Percent Change in Patient Health Questionnaire - 9 Scale Score.(Pre-surgery baseline to treatment phase end (up to 197 days))
- Number of Participants With ≥1 Point Increase in Glasgow Outcome Scale - Extended Scale Score(Pre-surgery baseline to treatment phase end (up to 197 days))
研究者
Jaimie M. Henderson
John and Jene Blume - Robert and Ruth Halperin Professor
Stanford University