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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dementia
Interventions Device: 1072nm infrared Photobiomodulation
Device: Photobiomodulation SIMULATED
Enrollment 11

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description received actual tx received placebo tx
Period Title: Overall Study
Started 6 5
Completed 6 3
Not Completed 0 2
Arm/Group Title Treatment Group Placebo Group Total
Hide Arm/Group Description received actual tx received placebo tx Total of all reporting groups
Overall Number of Baseline Participants 6 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 9 participants
80
(74 to 89)
84
(76 to 96)
81
(74 to 96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
Female
2
  33.3%
2
  66.7%
4
  44.4%
Male
4
  66.7%
1
  33.3%
5
  55.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 3 participants 9 participants
6
 100.0%
3
 100.0%
9
 100.0%
Delayed word recall   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 6 participants 3 participants 9 participants
0.50
(0 to 1)
1.33
(0 to 4)
0.798
(0 to 4)
[1]
Measure 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.
Trail making A   [1] 
Mean (Full Range)
Unit of measure:  Errors at task
Number Analyzed 6 participants 3 participants 9 participants
0.83
(0 to 5)
9.00
(3 to 14)
3.56
(0 to 14)
[1]
Measure Description: The Trail Making Test (TMT) is used to investigate deficits in cognitive processing speed and executive function. Part A consists of 25 circles on a piece of paper with the numbers 1-25 in random order in the circles. The patient starts with number one and draws a line from that circle to the circle with number two, etc. to number 25. More errors indicate poorer performance.
1.Primary Outcome
Title Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:
received actual tx
received placebo tx
Overall Number of Participants Analyzed 6 3
Mean (Full Range)
Unit of Measure: units on a scale
3.17
(2 to 4)
3
(3 to 3)
Time Frame Course of study, approx. 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description received actual tx received placebo tx
All-Cause Mortality
Treatment Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/3 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marvin Berman, PhD
Organization: QuietMind Foundation
Phone: 610.940.0488
Responsible Party: Marvin H. Berman, Ph.D., Quietmind Foundation
ClinicalTrials.gov Identifier: NCT01059877     History of Changes
Other Study ID Numbers: QMF-MID12610
First Submitted: January 28, 2010
First Posted: February 1, 2010
Results First Submitted: August 3, 2017
Results First Posted: September 27, 2018
Last Update Posted: September 27, 2018