Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:9/29/2018
Start Date:January 2010
End Date:February 2012

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Assessing the Effect of 1072nm Infrared (IR) Phototherapy on the Behavioral and Cognitive Symptoms Associated With Early and Mid-stage Dementia: a Randomized Placebo-controlled Clinical Trial.

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.

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.

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).
We found this trial at
1
site
Plymouth Meeting, Pennsylvania 19462
?
mi
from
Plymouth Meeting, PA
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