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Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

This study has been completed.
Sponsor:
Collaborator:
Cognitolite, LLC
Information provided by (Responsible Party):
Marvin H. Berman, Ph.D., Quietmind Foundation
ClinicalTrials.gov Identifier:
NCT01059877
First received: January 28, 2010
Last updated: February 23, 2012
Last verified: February 2012

January 28, 2010
February 23, 2012
January 2010
February 2012   (final data collection date for primary outcome measure)
change in cerebral oxygenation as measured by infrared spectroscopy. [ Time Frame: before and after each treatment administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01059877 on ClinicalTrials.gov Archive Site
changes in neuropsychological and functional behaviors as observed by the primary caregivers and the subject. [ Time Frame: pre and post treatment protocol (28 consecutive daily treatments ) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Dementia
Device: 1072nm infrared light stimulation
1072nm infrared light delivering 2.6J/sq cm over a 6 minute treatment period.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
February 2012
February 2012   (final data collection date for primary outcome measure)

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, 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).
Both
50 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01059877
QMF-MID12610
Yes
Marvin H. Berman, Ph.D., Quietmind Foundation
Quietmind Foundation
Cognitolite, LLC
Principal Investigator: Marvin H Berman, Ph.D Quietmind Foundation
Quietmind Foundation
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP