Who is sponsoring NCT02356861?

NCT02356861 is sponsored by VA Office of Research and Development.

What condition does NCT02356861 study?

NCT02356861 studies Traumatic Brain Injury (TBI), Post-traumatic Stress Disorder (PTSD).

Is NCT02356861 still recruiting?

NCT02356861 is currently withdrawn. Last updated 9 March 2022.

Last reviewed 2022-03-09 · How we verify

NCT02356861

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans

Withdrawn NA Last updated 9 March 2022

What this trial tests

NA trial testing Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on in Traumatic Brain Injury (TBI). Withdrawn.

Timeline

1 March 2016

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Start date	1 March 2016
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on

Conditions studied

Traumatic Brain Injury (TBI) — all drugs for Traumatic Brain Injury (TBI) →
Post-traumatic Stress Disorder (PTSD) — all drugs for Post-traumatic Stress Disorder (PTSD) →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 65, any sex, with Traumatic Brain Injury (TBI) or Post-traumatic Stress Disorder (PTSD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to learn if an experimental treatment can help thinking ability, and memory in Veterans with mild or moderate traumatic brain injury (mTBI), and post-traumatic stress disorder (PTSD). The experimental treatment is called transcranial, light-emitting diode (LEDs) therapy,and uses groups of LEDs mounted inside a helmet. The helmet is worn on the head, and the LEDs shine painless light on the sides, middle and front of the head through the scalp. The participants receive a series of LED treatments which take place as outpatient visits at the VA Boston Healthcare System, Jamaica Plain Campus. The LEDs contain near-infrared diodes. The FDA considers the LED device used here, to be a non-significant risk device. The LEDs do not produce heat.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Selective photobiomodulation for emotion regulation: model-based dosimetry study.
Cassano P, Tran AP, Katnani H, Bleier BS, et al · · 2019 · cited 49× · PMID 30796882 · DOI 10.1117/1.nph.6.1.015004

Verify or expand the search:

Other recruiting trials for Traumatic Brain Injury (TBI)

Currently open trials in the same condition.

NCT07493096 — Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disor · recruiting
NCT06725108 — Hemodynamic ABI Monitor · recruiting

Other VA Office of Research and Development trials

Trials by the same sponsor.

NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02356861 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 9 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02356861.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing