Development and validation of Transcranial Infrared Laser Therapy prototype on cognitive function, quality of life in elderly population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Quality of life using WHOBREF.
研究概览
简要总结
Design and Development of Transcranial Infra-Red Laser Therapy: The prototype system is currently based on infrared lasers using a wavelength of 810 nm. This wavelength has recently been proven one of the best for transcranial laser Stimulation. By comparing the fluence distribution, penetration depth, and the intensity of the laser-tissue interaction, it is found that 810 and 660 nm performed much better than other wavelengths. The proposed laser helmet or transcranial infra-red laser therapy prototype will have 35 active lasers using the parameters Indicated. The instrument will be developed in collaboration with industry partner Techno med Electronics. The duration of the stimulation will be 20 min.
Then, two sensors will be applied in the frontal area on the right and left sides of the brain of a healthy volunteer. To minimize the influence of external light, the head in this area will be covered with an elastic band during the recording and stimulation procedure. After a resting time of 15 min, the laser stimulation will be started.
The laser helmet will be placed on the skull and treated for a minimum of 20-minute duration for five weeks. A total of 20 participants will be recruited mainly through the screening procedure. For the cognitive function study, there will be 20 participants (10 males and ten postmenopausal females) aged 60–80 with self-reported subjective memory complaints. Our strategy will focus on cognitively at-risk adults and exclude participants with already established cardiovascular disease or dementia. Other exclusion criteria will be current pregnancy, prior institutionalization, diagnosis of psychotic disorder, or history of violent behavior. After obtaining the institutional Ethics Clearance and informed consent, participants will be recruited for the study.
The consent form explained the safety procedures used in the operation of the laser throughout the treatment sessions. Separate consent will be sought for participants who participated in the neural studies. Once the procedure and rationale of the study are made clear to the participant, Trans Cranial Infrared Laser stimulation —TILS will be administered daily for a 20-minute duration and a minimum of 5 sessions per week for the five-week duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Both gender
- •Age group of 60- 80 years
- •Volunteers with subjective memory complaints.
排除标准
- •Known case of cardiovascular disease or dementia
- •Current pregnancy, as laser therapy is not usually exposed.
- •Prior institutionalization
- •Diagnosis of psychotic disorder
- •History of violent behavior.
结局指标
主要结局
1. Quality of life using WHOBREF.
时间窗: Baseline | After 5 weeks | After 12 weeks
2. Cognitive function using a Brief Cognitive rating scale
时间窗: Baseline | After 5 weeks | After 12 weeks
次要结局
- N/A(N/A)
研究者
Dr G Arun Maiya
Manipal Academy of Higher Education
