Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

Not Applicable

Completed

Interventions: Device: 1072nm infrared Photobiomodulation
Device: Photobiomodulation SIMULATED

Brief Summary: This study will employ a double-blind, placebo-controlled approach to assess the effect of 1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with early and mid-stage dementia.

Detailed Description: What hypotheses are you testing?

We are seeking to determine if the provision of brief, repeated exposure to 1072nm infrared stimulation of the cortex surface improves cognitive and behavioral functioning as indicated by normalization of EEG activity, increased cerebral oxygenation and demonstrated improvement on standardized neuropsychological measures.

Intensive near infrared stimulation has been shown to be effective in accelerating healing of injuries and functional modification including increasing blood flow and perfusion. Dementia research has suggested that hypoperfusion is a significant underlying mechanism in the progression of dementia. Infrared spectroscopy has been shown effective in the non-invasive measurement of changes in cerebral oxygenation and perfusion. This study therefore seeks to explore whether the increasing of regional cerebral perfusion and oxygenation using infrared light stimulation will result in improved cognitive and behavioral functioning.

Recruitment & Eligibility

Inclusion Criteria

Aged between 50 - 85 years.
Have established cognitive impairment, Mini Mental Status Examination (MMSE) score between 15- 25 (from a possible score of 30).
Generally healthy otherwise as indicated by recent physical examination.
Have a caregiver/informant who has cared for the patient at least 5 days a week and is willing to attend study visits and provide information about the patient.
If taking any psychotropic medication should have been stable for the previous 3 months.
Must have had B12, folic acid, full blood count and ferritin screen within the previous 6 months or be on B12 and/or folic acid replacement.

Exclusion Criteria

Uncontrolled or unstable chronic illness, e.g., hypertension, chronic obstructive pulmonary disease (COPD).
Diagnosed actively growing intracranial pathology (tumors etc).
An associated psychotic illness.
Misusing illegal substances or alcohol.
On regular systemic steroids or anti-metabolites.
Systemic malignancies and/or space occupying lesions in the brain.
Not fluent in English.
Depressed as assessed by Beck Depression Inventory score.
Epilepsy.
Lacking the capacity to give informed consent.
Previous history of stroke or heart attack.
History of aggression or violence.
Inability to travel to the research venue for multiple assessments.
A history of major psychiatric illness, seizure disorder, or physical illness that would compromise their participation in a daily treatment regimen.
A participant may be disqualified if their performance is above the normative mean or below the lowest interpretable score of neuropsychological tests provided during the initial assessment (see #6, Sources of research material obtained from study participants, below).

Arm && Interventions

Group	Intervention	Description
1072nm Infrared Photobiomodulation	1072nm infrared Photobiomodulation	Received treatment for dementia with transcranial 1072nm infrared light stimulation.
Placebo	Photobiomodulation SIMULATED	Placebo device simulated transcranial photobiomodulation

Primary Outcome Measures

Name	Time	Method
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.	Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.	Delayed Word Recall is a subscale of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), a measure of cognitive impairment. Higher scores indicate greater impairment. Range: 0-10. Measures were taken within 72 hours of the first day of treatment and within 72 hours following the 28th day of treatment. Outcome measure was calculated by subtracting pretest from post test ADAS-Cog measurements.

Secondary Outcome Measures