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

NCT03420456 | Terminated DMC

• 1 other identifier: 2017P002231
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks - Sequential-parallel comparison design

Secondary Outcomes (1)

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

  8 weeks - Sequential-parallel comparison design

Study Arms (1)

Transcranial Light Therapy

EXPERIMENTAL

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

Interventions

Transcranial Light Therapy DEVICE

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.

Also known as: Low Level Laser-Light Therapy, Photobiomodulation

Transcranial Light Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• NYU Langone Health: collaborator
• Cerebral Sciences LLC: collaborator

Study Sites (1)

Massachusetts General Hospital- Center for Anxiety and Traumatic Stress Disorders

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Paolo Cassano, MD

  Center for Anxiety and Traumatic Stress Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label pilot study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: Pilot study

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: September 24, 2018
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)