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Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study (Lighten-GAD)

Primary Purpose

Generalized Anxiety Disorder

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Light Therapy

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects age at screening will be between 18 and 70 years old (inclusive).
Diagnosis of generalized anxiety disorder (MINI) - primary disorder
CGI-S ≥4 or higher, i.e., "moderately anxious"
Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active.
Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
The subject is willing to participate in this study for at least 16 weeks.
Subjects will need to be on stable dose(s) of anti-anxiety treatments (if taking any) for at least six weeks prior to enrollment.

Exclusion Criteria:

The subject is pregnant or lactating.
Structured psychotherapy focused on treating the subject's anxiety (i.e. CBT) and other alternative interventions for anxiety are permitted if started at least 8 weeks prior to the screening visit.
Substance dependence or abuse in the past 3 months.
History of a psychotic disorder or psychotic episode (current psychotic episode per MINI assessment).
Bipolar affective disorder (per MINI assessment).
Unstable medical illness, defined as any medical illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, HCTZ for hypertension).
Active suicidal or homicidal ideation (both intention and plan are present), as determined by C-SSRS screening.
Cognitive impairment (MOCA<21)
The subject has a significant skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject's scalp that is found to be in proximity to any of the procedure sites.
The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve).
Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer)
Recent history of stroke (90 days).

Sites / Locations

Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Light Therapy

Arm Description

Transcranial light therapy penetrates the skin and brain using light energy and the light energy may activate under-stimulated brain regions.

Outcomes

Primary Outcome Measures

Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A)

This instrument is completed by the clinician based on his/her assessment of the patient's anxiety symptoms, using a structured interview, specific instructions, and defined anchor points. Answers to the questions are rated on a scale of 0-4, with higher scores indicating more severe pathology. Scores range between 0 to 56; <17 indicates mild severity, 18-24 mild-to-moderate severity, and 25-30 moderate to severe.

Secondary Outcome Measures

Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I)

These two instruments are scored 1-7 by the clinician based on assessment of the subject's overall clinical status. They measure, based on history and scores on other instruments: (a) symptom severity (CGI-S) and (b) clinical improvement (CGI-I).

Full Information

NCT ID

NCT03420456

First Posted

January 29, 2018

Last Updated

August 3, 2020

Sponsor

Massachusetts General Hospital

Collaborators

NYU Langone Health, Cerebral Sciences LLC

1. Study Identification

Unique Protocol Identification Number

NCT03420456

Brief Title

Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study

Acronym

Lighten-GAD

Official Title

Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study (Lighten-GAD)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

Sponsor withdrew funding for reasons unrelated to safety or efficacy

Study Start Date

September 24, 2018 (Actual)

Primary Completion Date

May 6, 2019 (Actual)

Study Completion Date

May 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

NYU Langone Health, Cerebral Sciences LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Transcranial Light Therapy involves non-invasive and invisible beams of light that increase energy metabolism in the brain. Transcranial light therapy has been found to promote brain metabolism which may help people with anxiety. The research team proposes a novel approach to treating anxiety by using transcranial light therapy.

Detailed Description

The purpose of this study is to see if using Transcranial Light Therapy (TLT), also called near- infrared light, helps improve symptoms of generalized anxiety disorder (GAD). Subjects will be randomized at a 1:2 ratio into 2 groups: pulse light (TLT) and sham. The sham group will be randomized after 8 weeks at a 1:1 ratio in to TLT and sham. The study involves 1 screening visit which may last up to 3 hours, 16 weekly study visits, and one follow-up visit. There are 2 in-office treatment visits, during which a clinician applies transcranial light therapy to the participant's head for about 30 minutes. The other study visits involve assessments with a study clinician. The participants will administer the treatment once daily at home during the 16-week treatment period. If a participant qualifies for the study, the study team assigns the participant by chance to receive either active transcranial light therapy or sham transcranial light therapy treatment. During sham transcranial light therapy visits, the transcranial light therapy device will not produce near infrared waves (e.g., light energy that cannot penetrate the skin and cranium). Participants have more than an equal chance of being assigned to the active transcranial light therapy or the sham transcranial light therapy over the course of the study. Neither the participant, nor the clinician, nor any research staff other than the study statistician will know which study group the participant belongs. Participants are randomized a second time after 8-weeks in the study. If the participant were in the sham group the first 8-weeks, that participant may receive the active transcranial light therapy treatment after re-randomization. If the participant were already in the active transcranial light therapy group during the first 8-weeks the participant continues receiving the active treatment. All in all, participants have a 2 in 3 chance of receiving the active transcranial light therapy treatment at some point during the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pilot study

Masking

None (Open Label)

Masking Description

This is an open label pilot study

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcranial Light Therapy

Arm Type

Experimental

Arm Description

Transcranial light therapy penetrates the skin and brain using light energy and the light energy may activate under-stimulated brain regions.

Intervention Type

Device

Intervention Name(s)

Transcranial Light Therapy

Other Intervention Name(s)

Low Level Laser-Light Therapy, Photobiomodulation

Intervention Description

Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.

Primary Outcome Measure Information:

Title

Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A)

Description

Time Frame

8 weeks - Sequential-parallel comparison design

Secondary Outcome Measure Information:

Title

Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I)

Description

Time Frame

8 weeks - Sequential-parallel comparison design

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects age at screening will be between 18 and 70 years old (inclusive). Diagnosis of generalized anxiety disorder (MINI) - primary disorder CGI-S ≥4 or higher, i.e., "moderately anxious" Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active. Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study. The subject is willing to participate in this study for at least 16 weeks. Subjects will need to be on stable dose(s) of anti-anxiety treatments (if taking any) for at least six weeks prior to enrollment. Exclusion Criteria: The subject is pregnant or lactating. Structured psychotherapy focused on treating the subject's anxiety (i.e. CBT) and other alternative interventions for anxiety are permitted if started at least 8 weeks prior to the screening visit. Substance dependence or abuse in the past 3 months. History of a psychotic disorder or psychotic episode (current psychotic episode per MINI assessment). Bipolar affective disorder (per MINI assessment). Unstable medical illness, defined as any medical illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, HCTZ for hypertension). Active suicidal or homicidal ideation (both intention and plan are present), as determined by C-SSRS screening. Cognitive impairment (MOCA<21) The subject has a significant skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject's scalp that is found to be in proximity to any of the procedure sites. The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve). Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer) Recent history of stroke (90 days).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paolo Cassano, MD

Organizational Affiliation

Center for Anxiety and Traumatic Stress Disorders

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Personally unidentifiable information will be sent to Dr. Anastasia Ivanova, a privately contracted biostatistician form Chapel Hill North Carolina, for consultation on analyses. All information sent to Dr. Ivanova uses acrostics in place of personally identifiable information.

Learn more about this trial

Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study

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