Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Post concussive symptoms in TBI
研究概览
简要总结
This study investigates the efficacy of a novel neurorehabilitation program combining noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive therapy, on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).
详细描述
The most common blast-induced traumatic brain injury (bTBI)-associated problems are cognitive deficits, such as executive functioning and memory. This study evaluates a combined rehabilitation program: transcranial magnetic stimulation (TMS) and cognitive therapy for treatment of patients with bTBI. TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular brain region. Half of the study participants will receive cognitive intervention with active TMS, and a control group will receive cognitive intervention with sham TMS. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System and Beth Israel Deaconess Medical Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OEF/OIF active-duty personnel or veterans exposed to blast
- •Meets criteria for mild TBI
- •LOC of 30 min or less
- •Age: 21-50
- •Primary language is English
排除标准
- •Evidence of penetrating head injury
- •History of previous neurological diagnosis
- •History of previous psychotic disorder prior to the blast exposure
- •Hearing or vision impairment
研究组 & 干预措施
Active TMS and Cognitive Intervention
Active TMS and Cognitive Intervention:
Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Active TMS and Cognitive Intervention
Active TMS and Cognitive Intervention:
Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).
干预措施: Cognitive Intervention (Behavioral)
Sham TMS and Cognitive Intervention:
Sham TMS and Cognitive Intervention:
Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Sham TMS and Cognitive Intervention:
Sham TMS and Cognitive Intervention:
Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).
干预措施: Cognitive Intervention (Behavioral)
结局指标
主要结局
Post concussive symptoms in TBI
时间窗: 4 weeks
Neurobehavioral Symptoms Inventory (NSI) is a 22-item measure that assesses the post-concussive symptoms in patients with TBI.The NSI asks the patient to rate each of the symptoms according to how much the symptom has disturbed him/her using a five point scale. Patient ratings are based on descriptions of the frequency of the symptom, the extent to which the symptom disrupts the patient's activities, and the patient's perceived need for help with the symptom. A total score will be summated. Lower scores are more favorable.
次要结局
- Daily life and functional outcome(4 weeks)
- PTSD symptoms(4 weeks)
研究者
Yelena Bogdanova, PhD
BUMC Faculty
Boston Medical Center