Skip to main content
OpenTrials
Completed

NCT Number: NCT01059877

Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quietmind Foundation

Plymouth Meeting, Pennsylvania, 19462, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

1072nm infrared Photobiomodulation

Device

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

Other names: Photobiomodulation, Low-level LED Light Stimulation

Photobiomodulation SIMULATED

Device

Device mounted and procedure followed but with no stimulation.

Primary outcomes

  1. Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Quietmind Foundation

Other

Collaborators

  • Maculume Ltd.

Registry information

Official study title

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.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2010
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.