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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03420456
Recruitment Status : Unknown
Verified February 2018 by Paolo Cassano, Massachusetts General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 5, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborators:
NYU Langone Health
Cerebral Sciences LLC
Information provided by (Responsible Party):
Paolo Cassano, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Device: Transcranial Light Therapy Device: Sham Transcranial Light Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2-phase sequential parallel design
Masking: Double (Participant, Investigator)
Masking Description: All subjects and investigators (except the study statistician) will be blind to treatment sequence assignment.
Primary Purpose: Treatment
Official Title: Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study (Lighten-GAD)
Estimated Study Start Date : February 26, 2018
Estimated Primary Completion Date : February 25, 2019
Estimated Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Transcranial Light Therapy
Transcranial light therapy penetrates the skin and brain using light energy and the light energy may activate under-stimulated brain regions.
Device: Transcranial Light Therapy
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.
Other Names:
  • Low Level Laser-Light Therapy
  • Photobiomodulation

Sham Comparator: Sham Transcranial Light Therapy
For the sham group, the transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy.
Device: Transcranial Light Therapy
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.
Other Names:
  • Low Level Laser-Light Therapy
  • Photobiomodulation

Device: Sham Transcranial Light Therapy
The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
Other Name: Placebo




Primary Outcome Measures :
  1. Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) [ Time Frame: 8 weeks - Sequential-parallel comparison design ]
    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 :
  1. Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I) [ Time Frame: 8 weeks - Sequential-parallel comparison design ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420456


Contacts
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Contact: Samantha Hellberg, BA (617) 724-0666 shellberg@mgh.harvard.edu
Contact: Sarah Wieman, BA 617-726-3508 swieman@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders
Boston, Massachusetts, United States, 02114
Contact: Samantha Hellberg, BA    617-724-0666    shellberg@mgh.harvard.edu   
Contact: Sarah Wieman, BA    617-726-3508    swieman@mgh.harvard.edu   
Principal Investigator: Paolo Cassano, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
NYU Langone Health
Cerebral Sciences LLC
Investigators
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Principal Investigator: Paolo Cassano, MD Center for Anxiety and Traumatic Stress Disorders
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Responsible Party: Paolo Cassano, Assistant Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03420456    
Other Study ID Numbers: 2017P002231
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders