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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

Tracking Information
First Submitted Date  ICMJE January 28, 2010
First Posted Date  ICMJE February 1, 2010
Results First Submitted Date  ICMJE August 3, 2017
Results First Posted Date  ICMJE September 27, 2018
Last Update Posted Date September 27, 2018
Study Start Date  ICMJE January 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2010)
change in cerebral oxygenation as measured by infrared spectroscopy. [ Time Frame: before and after each treatment administration ]
Change History Complete list of historical versions of study NCT01059877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2010)
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 ) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Small placebo controlled randomized trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dementia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2012)
11
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2010)
24
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01059877
Other Study ID Numbers  ICMJE QMF-MID12610
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marvin H. Berman, Ph.D., Quietmind Foundation
Study Sponsor  ICMJE Quietmind Foundation
Collaborators  ICMJE Maculume Limited
Investigators  ICMJE
Principal Investigator: Marvin H Berman, Ph.D Quietmind Foundation
PRS Account Quietmind Foundation
Verification Date August 2018

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