Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Small placebo controlled randomized trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1072nm Infrared Photobiomodulation

Received treatment for dementia with transcranial 1072nm infrared light stimulation.

Group Type ACTIVE_COMPARATOR

1072nm infrared Photobiomodulation

Intervention Type DEVICE

1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.

Placebo

Placebo device simulated transcranial photobiomodulation

Group Type PLACEBO_COMPARATOR

Photobiomodulation SIMULATED

Intervention Type DEVICE

Device mounted and procedure followed but with no stimulation.

Interventions

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1072nm infrared Photobiomodulation

1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.

Intervention Type DEVICE

Photobiomodulation SIMULATED

Device mounted and procedure followed but with no stimulation.

Intervention Type DEVICE

Other Intervention Names

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Photobiomodulation, Low-level LED Light Stimulation

Eligibility Criteria

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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).

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes