Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training

The University of Texas System (UT)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Social Phobia; Phobias; Claustrophobia

Treatments: Device: Low-Level Laser Therapy; Behavioral: Extinction Training; Device: Sham Low-Level Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02926352

2013-12-0068

Details and patient eligibility

About

There are two specific aims for this study. Aim 1 is to test whether low-level laser therapy (LLLT) can enhance the efficacy of fear extinction training in the modification of pathological fear. Aim 2 is to investigate the efficacy of low-level laser therapy (LLLT) as a stand-alone intervention for anxiety/phobias.

Full description

Preliminary research with non-human animals suggests that LLLT (i.e., ultra low doses of transcranial infrared light) can enhance the retention of fear extinction learning by up regulating neuronal metabolic activity when applied to the ventromedial prefrontal cortex (vmPFC). Furthermore, evidence from a previous uncontrolled trial with humans suggests that LLLT (outside the context of extinction training) can lead to a significant decrease in symptoms of depression and anxiety when applied to the right and left dorsolateral prefrontal cortices (dlPFC). The first aim of this study is to test whether LLLT can boost fear reduction after extinction training in humans. A second aim of this study is to investigate the efficacy of LLLT as a stand-alone anxiolytic intervention in a randomized controlled trial.

Individuals between the ages of 18-65 with elevated fear in any of one of four domains (e.g., fear of enclosed spaces, fear of contamination, fear of public speaking, or anxiety sensitivity) are randomly assigned to one of four treatment arms (1) Extinction Training with LLLT, (2) Extinction Training with Sham LLLT, (3) LLLT alone, or (4) Sham LLLT alone.

To determine eligibility, all participants undergo an online prescreen and a face-to-face screening assessment. Participants who qualify for the study then complete a baseline (pre-treatment) assessment, followed immediately by the treatment procedure and a post-treatment assessment. Participants return to the lab an average of 14 days after treatment to complete a follow-up assessment. Participants complete two behavioral approach tests (in the treatment context and in the generalization context) at baseline, post-treatment, and follow-up, and a battery of self-report questionnaires at baseline and follow-up.

Enrollment: 112 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ages 18-65
2. Behavioral Approach Test (BAT) peak fear rating equal to or greater than 50/100 on both BATs (i.e., treatment and generalization contexts).

Exclusion criteria

1. High risk for suicide as determined by a clinical assessment, which will occur if a participant indicates that they are currently experiencing suicidal ideation on the depression module of the Mini International Neuropsychiatric Inventory, or on item 9 of the Beck Depression Inventory.
2. Psychotropic medication taken within the past 4 weeks.
3. Currently Receiving treatment for the fear domain in question.
4. Presence of a medical condition (i.e., pregnancy, seizure disorder, respiratory disorder, cardiovascular disease) that would contraindicate participation in one or more treatment or assessment activities as determined by a Medical History Questionnaire.
5. Active neurological condition (such as epilepsy or stroke) as determined by a Medical History Questionnaire.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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112 participants in 4 patient groups

Extinction Training with LLLT

Experimental group

Description:

Participants will receive one-session of fear extinction training tailored to the participant's specific fear domain. 15 minutes after fear extinction, participants will receive 8 minutes of Low-Level Laser Therapy stimulation. The laser will be directed at two areas on the forehead: bilateral frontal points Fp1 and Fp2 (on the EEG electrode placement system; to stimulate the vmPFC). Each area will be stimulated for 4 minutes. Treatment will consist of alternating between each of these points after each minute.

Treatment:

Behavioral: Extinction Training

Device: Low-Level Laser Therapy

Extinction Training with Sham LLLT

Active Comparator group

Description:

Participants will receive one-session of fear extinction training tailored to the participant's specific fear. 15 minutes after fear extinction, participants will receive 8 minutes of Sham Low-Level Laser Therapy stimulation. The laser will be directed at two areas on the forehead: bilateral frontal points Fp1 and Fp2 (on the EEG electrode placement system). The procedure will consist of alternating between each of these points after each minute. However, each point will receive only a brief (5-second) treatment to the intended site on the forehead, followed by 55 seconds of no treatment, for each one-minute cycle, functioning as a placebo dose of the treatment.

Treatment:

Device: Sham Low-Level Laser Therapy

Behavioral: Extinction Training

LLLT alone

Experimental group

Description:

Participants will receive 8 minutes of Low-Level Laser Therapy stimulation. The laser will be targeted first at the left forehead point F3 and then at the right forehead point F4 (on the EEG electrode placement system). F3 corresponds with the left dorsolateral prefrontal cortex and F4 corresponds with the right dorsolateral prefrontal cortex. Each area will be stimulated for 4 minutes. Treatment will consist of alternating between each of these points after each minute.

Treatment:

Device: Low-Level Laser Therapy

Sham LLLT alone

Sham Comparator group

Description:

Participants will receive 8 minutes of Sham Low-Level Laser Therapy stimulation. The laser will be targeted first at the left forehead point F3 and then at the right forehead point F4 (on the EEG electrode placement system). The procedure will consist of alternating between each of these points after each minute. However, each point will receive only a brief (5-second) treatment to the intended site on the forehead, followed by 55 seconds of no treatment, for each one-minute cycle, functioning as a placebo dose of the treatment.

Treatment:

Device: Sham Low-Level Laser Therapy