Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Metabolism and Function in Post-traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Cerebral CCO Changes in Response to TILS and Sham
研究概览
简要总结
This study evaluates the effects of transcranial infrared laser stimulation (TILS) on prefrontal metabolism and hemodynamics in veterans with post-traumatic stress disorder (PTSD). The subjects will receive six TILS interventions and one sham intervention in a course of seven weeks.
详细描述
Post-traumatic stress disorder (PTSD) is often associated with cognitive impairments. It has been indicated that hypoactivity of the prefrontal cortex plays a major role in the disrupted neural circuitry of mood and cognition.
Transcranial infrared laser stimulation (TILS) is a neural type of photobiomodulation that can elevate neuronal metabolism by exciting cytochrome c oxidase (CCO). Veterans with PTSD will receive prefrontal TILS interventions once-per-week for six weeks. They will also receive an additional sham intervention (laser power = 0) that will be randomly assigned into the first two sessions. Broadband near-infrared spectroscopy (bbNIRS) will be used to directly assess the CCO changes during every TILS/sham session.
Veterans' prefrontal functions will be evaluated with short-term memory tasks before and after each intervention. The prefrontal activities will also be imaged by functional near-infrared spectroscopy (fNIRS) to objectively assess the functional changes due to TILS/sham interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •War-zone and non-war-zone veterans
- •Ages 18-60 years old
- •Males and females
- •Able to read, speak, and understand English
- •Medical records showing prior diagnosis of PTSD (here it refers to the records prior to TILS, which will be assessed and obtained in Visit 1)
- •Medical records showing diagnosis of PTSD (here it refers to the CAPS-5 record prior to TILS, which will be assessed and obtained in Visit 1)
- •On stable doses of any psychotropic medications for at least 4 weeks
排除标准
- •Significant physical disability to perform a computerized memory task
- •Past/current significant medical/neurological/mental health disorders known to affect cognitive functioning (e.g., stroke, dementia, schizophrenia, AIDS)
- •Presence of moderate/severe TBI, defined as having: alteration of consciousness/mental state >24 hours; posttraumatic amnesia >1 day; loss of consciousness >30 minutes; and/or abnormal structural neuroimaging. We will not exclude veterans with mild TBI, which is found in nearly 50% of veterans with PTSD
- •Alcohol abuse/dependence for the past 12- months, as determined by the Rapid Alcohol Problems Screen score >0
- •Drug abuse/dependence for the past 12- months, as determined by the Drug Abuse Screening Test-10 score >2
- •Severe depression (PHQ-9 total score >19), significant risk of suicide (SBQ-R >6), severe headache (PHQ-15, Item e =2), and/or severe dizziness (PHQ-15, Item g =2)
- •Opiate use in the month prior to study entry
结局指标
主要结局
Cerebral CCO Changes in Response to TILS and Sham
时间窗: 7 weeks
Cerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.
Cerebral Hemodynamic Changes in Response to TILS and Sham
时间窗: 7 weeks
Cerebral hemodynamic changes measured by broadband NIRS during every TILS or sham session
次要结局
- Prefrontal Activations in Short-term Memory Processing(8 weeks)
- Short-term Memory Scores(8 weeks)
研究者
Fenghua Tian, PhD
Assistant Professor of Research
The University of Texas at Arlington