Dose response on brain activity by low level light therapy of brai

Phase 4

• Registration Number: CTRI/2018/02/012075
• Lead Sponsor: Fogarty International Center of National Institutes of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Able to provide informed consent

2. Willingness to be randomized to Sham or Real stimulation groups

3. Willingness to undergo two brain MRI-MRS scans and commit time necessary for the study

4. Lives independently with no impairment in social or occupational function

•At least 8th grade education

•Scores > 25 on Hindi Mental State Examination

•On stable doses of major medications for last 3 months

•Score < 14 on the Beck Depression Inventory-II

Exclusion Criteria

1. Unstable and uncontrolled medical conditions; diagnosis of cancer

2. Previous major strokes or other known significant brain abnormalities, diseases, or disorders affecting cognition

3. Evidence of mild cognitive impairment or potential dementia, meeting DSM-V criteria for Major or Minor Neurocognitive Disorder

4. Current or past history of major psychiatric disturbance

•Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)

•Use of photo-sensitive medications within 15 days of the study intervention

•Presence of claustrophobia

•Implants such as pacemakers, heart vales, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Brain activity through resting state fMRITimepoint: Pre <br/ ><br>Immediate

Secondary Outcome Measures

Name	Time	Method
Creatinine/NAA ratio in prefrontal cortexTimepoint: Pre <br/ ><br>Immediate;Executive function-Working MemoryTimepoint: Pre <br/ ><br>Immediate;Global cognitive functionTimepoint: Pre <br/ ><br>Immediate;Glutamate/GABA ratio in Prefrontal cortexTimepoint: Pre <br/ ><br>Immediate;N-Acetyl Aspartate/ Myo-inositol ratio in prefrontal cortexTimepoint: Pre <br/ ><br>Immediate