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CTRI Number  CTRI/2024/01/061721 [Registered on: 22/01/2024] Trial Registered Prospectively
Last Modified On: 20/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Development and validation of light therapy device applied through head for improving cognition and quality of life in elderly population  
Scientific Title of Study   Development and validation of Transcranial Infrared Laser Therapy prototype on cognitive function, quality of life in elderly population 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Arun Maiya 
Designation  Chief Center for Diabetic Foot Care and Research Dean MCHP Professor Department of Physiotherapy 
Affiliation  Manipal Academy of Higher Education 
Address  Chief Center of Diabetic Foot Care and Research Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Health Education Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax  08202571915  
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Ms Grace Maria Joseph 
Designation  Junior Research Fellow 
Affiliation  Manipal Academy of Higher Education 
Address  Chief Center of Diabetic Foot Care and Research Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Health Education Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7406148321  
Fax    
Email  grace.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ms Tina Agnes 
Designation  Assistant Professor Department of Physiotherapy Manipal 
Affiliation  Manipal Academy of Higher Education 
Address  Chief Center of Diabetic Foot Care and Research Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Health Education Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9740688454  
Fax    
Email  tina.agnes@manipal.edu  
 
Source of Monetary or Material Support  
DST Nidhi Prayas Program Management Unit (PMU) Society for Innovation and Entrepreneurship (SINE) IIT Bombay, Powai, Mumbai - 400 076, India. 
 
Primary Sponsor  
Name  DST Nidhi Prayas 
Address  Manipal University Technology Business Incubator Society (R) 4th Floor, Advanced Research Center, MAHE Madhava Nagar, Manipal- 576104 Karnataka, India Ph: 08202925052 Mobile: 9900411040 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Arun Maiya  Kasturba Hospital Manipal  Kasturba Hospital Room No.4 Center for Diabetic Foot Care and Research Department of Physiotherapy First floor N block Manipal Karnataka 576104
Udupi
KARNATAKA 		 08202923054

arun.maiya@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ELDER INDIVIDUALS WITH SUBJECTIVE MEMORY LOSS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil   Nil No comparator agent 
Intervention  Transcranial Laser Therapy Pre-post study design within the group no comparator agent  Transcranial laser therapy will be administered daily for a 20-minute duration and a minimum of 5 sessions per week for the five-week duration.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Both gender
2. Age group of 60- 80 years
3. Volunteers with subjective memory complaints
 
 
ExclusionCriteria 
Details  1. Known case of cardiovascular disease or dementia
2. Current pregnancy, as laser therapy is not usually exposed.
3. Prior institutionalization
4. Diagnosis of psychotic disorder
5. History of violent behavior
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Quality of life using WHOBREF.
2. Cognitive function using a Brief Cognitive rating scale 		 Baseline
After 5 weeks
After 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

    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.

 
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