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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-09116 | Other Identifier | NCI Clinical Trial Registration Program |
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Survivors of childhood cancer are at greater risk for long-term cognitive impairments that include attention, executive function, intelligence, memory, and processing speed. The participants are a survivor of acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL). Because of your treatment the participant may have developed trouble with thinking and learning.
Primary Objective
To evaluate the feasibility of using home-based tPBM paired with remote cognitive training to improve cognitive performance in survivors of ALL and HL.
Secondary Objectives
To estimate the potential efficacy of alpha and gamma frequency tPBM on cognitive performance in survivors of ALL and HL.
Exploratory Objectives
To estimate the effects of home-based tPBM paired with remote cognitive training on patient reported symptoms of executive dysfunction, sleep, depression, anxiety, fatigue, and pain in survivors of ALL and HL.
Survivors with ALL and HL with identified executive function impairment will be randomized to receive stimulation with alpha tPBM + cognitive training, gamma tPBM + cognitive training or sham tPBM + cognitive training three days per week for a 2-month intervention period The tPBM will be applied to nodes in the default mode network.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alpha tPBM + cognitive training | Experimental | three days per week for a 2-month intervention period (5 ALL and 5 HL) |
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| gamma tPBM + cognitive training | Experimental | three days per week for a 2-month intervention period (5 ALL and 5 HL) |
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| sham tPBM + cognitive training | Experimental | Sham stimulations will act as the control for this study three days per week for a 2-month intervention period (5 ALL and 5 HL) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial photobiomodulation (tPBM) - Mobile System | Device | The Vielight NeURO device delivers 810 nm near infrared light via four (4) transcranial LED modules. The LED modules target brain regions associated with a variety of cognitive functions. It can deliver light at two frequencies: Alpha (10 Hz) and Gamma (40 Hz). Alpha oscillations are prominent in healthy brains during wakeful resting and gamma oscillations are associated with activities associated with focus, memory, and cognition. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who completed a two-month trial of paired photobiomodulation (PBM) therapy and cognitive training | The trial will be considered feasible if at least 15 of 30 survivors are able to complete 18 of 24 sessions (PBM along with cognitive training). | 4 months after participant enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| CNS Vital Signs adaptions of the Rey auditory verbal learning test (RVLT). | RVLT is a test that evaluate working memory. | 2 month and 4 months after enrollment |
| CNS Vital Signs adaptions of the Rey visual design learning (RVDL) test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Phillips, MD,PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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The proposed study is a double-blind, randomized placebo-controlled pilot study of remotely delivered tPBM paired with cognitive training.
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RVDL is a test that evaluate working memory.
| 2 month and 4 months after enrollment |
| CNS Vital Signs implemented Stroop color and word test. | The Stroop test is a test that evaluates Inhibitory control. | 2 month and 4 months after enrollment |
| CNS Vital Signs implemented Shifting Attention Test. | The Shifting attention test and Stroop test are tests that are used to measure cognitive flexibility. | 2 month and 4 months after enrollment |
| CNS Vital Signs implementation of the Continuous Performance Test (CPT). | The CPT test is a test that evaluates attention. | 2 month and 4 months after enrollment |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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