Behavioral Study of Effects of Low-Level Light Therapy on Mood and Reaction Time

NCT02390076 | Completed Results

• 1 other identifier: IMHR-0001
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this project is to use low-level light therapy (LLLT) to enhance neural metabolism in the prefrontal cortex of humans, and measure the effects of LLLT on attentional bias change following a single session of attention bias modification (ABM). LLLT is non-invasive, therapeutically beneficial, and promotes a wide range of biological effects including enhancement of energy production, gene expression and prevention of cell death. Previous research has indicated that human participants show a beneficial psychological effect, including improved mood and greater sustained attention, following a single treatment of LLLT to the forehead. ABM is a computer-based cognitive task designed to decrease the mood-congruent negative attentional bias frequently observed in depressed and dysphoric individuals. Previous ABM studies have led to decrease in clinical symptoms relative to a control condition. This study will explore whether the effects of LLLT on mood and attention could improve the potency of ABM, leading to greater attention change and greater improvement of mood relative to sham LLLT.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Presence and Severity of Depressive Symptoms Assessed by Center for Epidemiologic Studies - Depression Scale (CES-D)

  The CES-D (Radloff, 1977) is a 20-item, self-report scale designed to assess the presence and severity of depressive symptoms over the past week. The total range is 0-80, with higher scores reflecting more severe depression symptoms. Outcome measure data table reflects clinical symptoms at 2 week follow-up.

  At baseline, session 1, session 2, 1 week follow-up, and 2 week follow-up.

Secondary Outcomes (1)

• Biased Attention for Emotional Stimuli Measured by the Dot Probe Task

  Measure was administered at the beginning of session 1 and end of session 2.

Study Arms (3)

Left active LLLT

ACTIVE COMPARATOR

Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy

Device: Left Low Level Light Therapy; Other: Attention bias modification

Right active LLLT

ACTIVE COMPARATOR

Active LLLT targeting the right forehead Attention Bias Modification Right low level light therapy

Other: Attention bias modification; Device: Right Low Level Light Therapy

Sham LLLT

SHAM COMPARATOR

Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy

Other: Attention bias modification; Device: Sham Low Level Light Therapy

Interventions

Left Low Level Light Therapy DEVICE

Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead. The diameter parameters of stimulation are the same that showed psychologically beneficial effects in Schiffer et al. (2009). At the power level described, the energy emitted by the CG-5000 at this setting is one quarter of the skin MPE (0.250 W/cm2), exposure to it is not deemed harmful to tissue, and it causes no detectable physical damage and negligible heat.

Also known as: Transcranial laser stimulation

Left active LLLT

Attention bias modification OTHER

The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. The presentation of the probe will be staggered to maximize attention for the neutral stimulus. Latency and accuracy of the button press responses are recorded by the computer.

Also known as: Cognitive bias modification

Left active LLLT; Right active LLLT; Sham LLLT

Right Low Level Light Therapy DEVICE

Administration of right LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Right LLLT will target the right forehead. The diameter parameters of stimulation are the same that showed psychologically beneficial effects in Schiffer et al. (2009). At the power level described, the energy emitted by the CG-5000 at this setting is one quarter of the skin MPE (0.250 W/cm2), exposure to it is not deemed harmful to tissue, and it causes no detectable physical damage and negligible heat.

Also known as: Transcranial laser stimulation

Right active LLLT

Sham Low Level Light Therapy DEVICE

Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary threshold to elicit a response.

Also known as: Transcranial laser stimulation

Sham LLLT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 35 years old,
• English as first language,
• baseline CES-D score \> 16.

You may not qualify if:

• active neurological condition (such as epilepsy or stroke).

Sponsors & Collaborators

• Seth Disner: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Seth Disner
• Organization: Minneapolis VA Health Care System

disne014@umn.edu

3105605990

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral Candidate

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 8, 2019
• Results First Posted: May 8, 2019

Record last verified: 2019-04