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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dementia Device: 1072nm infrared Photobiomodulation Device: Photobiomodulation SIMULATED Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Small placebo controlled randomized trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Study Start Date : January 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1072nm Infrared Photobiomodulation
Received treatment for dementia with transcranial 1072nm infrared light stimulation.
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

Placebo Comparator: Placebo
Placebo device simulated transcranial photobiomodulation
Device: Photobiomodulation SIMULATED
Device mounted and procedure followed but with no stimulation.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059877


Locations
United States, Pennsylvania
Quietmind Foundation
Plymouth Meeting, Pennsylvania, United States, 19462
Sponsors and Collaborators
Quietmind Foundation
Maculume Limited
Investigators
Principal Investigator: Marvin H Berman, Ph.D Quietmind Foundation

Publications of Results:
Responsible Party: Marvin H. Berman, Ph.D., clinical trial coordinator, Quietmind Foundation
ClinicalTrials.gov Identifier: NCT01059877     History of Changes
Other Study ID Numbers: QMF-MID12610
First Posted: February 1, 2010    Key Record Dates
Results First Posted: September 27, 2018
Last Update Posted: September 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marvin H. Berman, Ph.D., Quietmind Foundation:
dementia alzheimers frontotemporal lyme,
lewy body cognitive impairment

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders