search
Back to results

Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1072nm infrared Photobiomodulation
Photobiomodulation SIMULATED
Sponsored by
Quietmind Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring dementia alzheimers frontotemporal lyme,, lewy body cognitive impairment

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Quietmind Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1072nm Infrared Photobiomodulation

Placebo

Arm Description

Received treatment for dementia with transcranial 1072nm infrared light stimulation.

Placebo device simulated transcranial photobiomodulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 28, 2010
Last Updated
August 29, 2018
Sponsor
Quietmind Foundation
Collaborators
Maculume Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01059877
Brief Title
Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Quietmind Foundation
Collaborators
Maculume Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia alzheimers frontotemporal lyme,, lewy body cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Small placebo controlled randomized trial.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1072nm Infrared Photobiomodulation
Arm Type
Active Comparator
Arm Description
Received treatment for dementia with transcranial 1072nm infrared light stimulation.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo device simulated transcranial photobiomodulation
Intervention Type
Device
Intervention Name(s)
1072nm infrared Photobiomodulation
Other Intervention Name(s)
Photobiomodulation, Low-level LED Light Stimulation
Intervention Description
1072nm infrared light delivering 2.6 Joules (2.6J)/sq cm over a 6 minute treatment period.
Intervention Type
Device
Intervention Name(s)
Photobiomodulation SIMULATED
Intervention Description
Device mounted and procedure followed but with no stimulation.
Primary Outcome Measure Information:
Title
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.
Description
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.
Time Frame
Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marvin H Berman, Ph.D
Organizational Affiliation
Quietmind Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quietmind Foundation
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28593105
Citation
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):176. doi: 10.21767/2171-6625.1000176. Epub 2017 Feb 28.
Results Reference
result

Learn more about this trial

Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

We'll reach out to this number within 24 hrs