tPBM in Older Adults With Traumatic Brain Injury

Официальное название

Transcranial Photobiomodulation in Older Adults With Traumatic Brain Injury: Effects on Cerebral Blood Flow and Cognition

Обзор

The purpose of this study is to evaluate the effect of transcranial photobiomodulation (tPBM) in older patients with chronic traumatic brain injury (TBI). The study aims to examine the effect of tPBM on prefrontal cerebral blood flow (CBF) and executive function (EF)

Вмешательства

• Устройство Transcranial photobiomodulator (tPBM)
  The tPBM-2.0 device consists of a therapeutic laser console (that produces laser energy as NIR), and an optical delivery system consisting of a flexible, double-sheathed optical fiber connected to a custom helmet (cap). tPBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead at the standard scalp location \~12 minutes per day, 3 days per week, for 6 weeks (18 total sessions).
• Устройство Transcranial photobiomodulator (tPBM) in sham mode
  The tPBM-2.0 device consists of a therapeutic laser console (which will be in sham mode, which does not produce laser energy), and an optical delivery system consisting of a flexible, double-sheathed optical fiber connected to a custom helmet (cap).

Первичные конечные точки

• Change in prefrontal Cerebral Blood Flow (CBF) [Срок оценки: Baseline, end-of-treatment (up to 6 weeks)]
• Change in Executive Function (EF) composite scores [Срок оценки: Baseline, end-of-treatment (up to 6 weeks)]

Вторичные конечные точки (1)

• Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) [Срок оценки: Baseline, end-of-treatment (up to 6 weeks)]

Критерии участия

Критерии включения

• Able to give written informed consent and follow study procedures.
• Age ≥ 55 years and ≤ 85 years.
• History of non-penetrating TBI of at least moderate severity,

• defined by Emergency Department Glasgow Coma Scale (GCS) < 13,
• or post-traumatic amnesia > 24 hours,
• or loss of consciousness > 30 minutes,
• or evidence of trauma-related abnormality on acute neuroimaging.
• Between 1 and 2 years post injury.

Критерии исключения

• Delayed loss of consciousness due to expanding lesions
• Diagnosis of dementia, history of brain tumor, or other serious neurological disorder
• Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of alcohol or drug use disorder or history of other major psychiatric illness diagnosed with Mini-International Neuropsychiatric Interview (MINI)
• History of significant cardiovascular or cerebrovascular pathology before sustaining TBI
• Unstable medical conditions or medications impacting cognition (e.g., topiramate)
• Significant skin conditions on the subject's scalp in the area of illumination
• Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres)
• Claustrophobia or metallic foreign bodies that would preclude MRI
• Unwilling/unable to comply with study as judged by the Principal Investigator
• Body mass index > 40 kg/m2 to fit comfortably in MRI
• Past intolerance or hypersensitivity to tPBM
• Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT06956404 · 24-00956 · CDMRP-TP230318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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