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Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

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ClinicalTrials.gov Identifier: NCT01059877
Recruitment Status : Completed
First Posted : February 1, 2010
Results First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Maculume Limited
Information provided by (Responsible Party):
Marvin H. Berman, Ph.D., Quietmind Foundation

January 28, 2010
February 1, 2010
August 3, 2017
September 27, 2018
September 27, 2018
January 2010
February 2012   (Final data collection date for primary outcome measure)
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.
change in cerebral oxygenation as measured by infrared spectroscopy. [ Time Frame: before and after each treatment administration ]
Complete list of historical versions of study NCT01059877 on ClinicalTrials.gov Archive Site
Not Provided
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 ) ]
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
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Small placebo controlled randomized trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Dementia
  • Device: 1072nm infrared Photobiomodulation
    1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.
    Other Name: Photobiomodulation, Low-level LED Light Stimulation
  • Device: Photobiomodulation SIMULATED
    Device mounted and procedure followed but with no stimulation.
  • Active Comparator: 1072nm Infrared Photobiomodulation
    Received treatment for dementia with transcranial 1072nm infrared light stimulation.
    Intervention: Device: 1072nm infrared Photobiomodulation
  • Placebo Comparator: Placebo
    Placebo device simulated transcranial photobiomodulation
    Intervention: Device: Photobiomodulation SIMULATED
Berman MH, Halper JP, Nichols TW, Jarrett H, Lundy A, Huang JH. Photobiomodulation with Near Infrared Light Helmet in a Pilot, Placebo Controlled Clinical Trial in Dementia Patients Testing Memory and Cognition. J Neurol Neurosci. 2017;8(1). pii: 176. doi: 10.21767/2171-6625.1000176. Epub 2017 Feb 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
24
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, 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).
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01059877
QMF-MID12610
Yes
Not Provided
Plan to Share IPD: No
Marvin H. Berman, Ph.D., Quietmind Foundation
Quietmind Foundation
Maculume Limited
Principal Investigator: Marvin H Berman, Ph.D Quietmind Foundation
Quietmind Foundation
August 2018

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