ALLNCT05550948
Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
A study testing Transcranial photobiomodulation (tPBM) - Mobile System in people with ALL and Hodgkin Lymphoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALL, Hodgkin Lymphoma, Cancer
- What is being tested?
- Transcranial photobiomodulation (tPBM) - Mobile System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 9 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed treatment for acute lymphoblastic leukemia (ALL) or Hodgkin's Lymphoma (HL) at SJCRH.
- Enrolled in SJLIFE, and less than 21 years of age at diagnosis.
- 18 years of age or older at time of enrollment.
- 2 years or greater post-treatment completion of cancer directed therapy and not currently receiving any cancer directed therapy.
- English language proficiency.
- Access to WiFi.
- Executive dysfunction defined as having an age-adjusted standard score less than 16th percentile on objectively assessed cognitive test or patient-reported executive dysfunction defined as having a standard score greater than 84th percentile within 3 years of time of enrollment.
Who cannot join
- Estimated intelligence score less than 80.
- Currently taking medication intended to treat neurocognitive impairment (i.e., stimulants).
- Major psychiatric condition.
- Alcohol abuse in the past year (AUDIT) [greater than or equal to 13 for women and greater than or equal to 15 for men]. The Alcohol Use Disorders Identification Test (AUDIT) will be used to screen for individuals who have active alcohol-use disorders.
- Drug abuse in the past year (DAST-10) [ greater than or equal to 3 for women or men] The Drug Abuse Screen Test (DAST-10) will be used to screen for individuals with active drug abuse.
- History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment.
Show all 9Show fewer
- Enrolled on another independent cognitive intervention protocol within the last year.
- Female participants who are pregnant or lactating (determined by participant self-report due to the remote nature of this study)
- Tattoo or artificial marking in the area where the device will be positioned.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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
Read more
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.
Read the detailed description
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.
- Conditions
- ALL, Hodgkin Lymphoma, Cancer, Survivorship
- Being tested
- Transcranial photobiomodulation (tPBM) - Mobile System
- Medical subject headings
- Hodgkin Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial photobiomodulation (tPBM) - Mobile SystemDevice
Also called Vielight portable tPBM NeURO 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.
| Study group | Role | What they receive |
|---|---|---|
| alpha tPBM + cognitive training | Experimental | three days per week for a 2-month intervention period (5 ALL and 5 HL) Receives: Device: Transcranial photobiomodulation (tPBM) - Mobile System |
| gamma tPBM + cognitive training | Experimental | three days per week for a 2-month intervention period (5 ALL and 5 HL) Receives: Device: Transcranial photobiomodulation (tPBM) - Mobile System |
| 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) Receives: Device: Transcranial photobiomodulation (tPBM) - Mobile System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months after participant enrollment
Secondary outcomes (5)
CNS Vital Signs adaptions of the Rey auditory verbal learning test (RVLT).
RVLT is a test that evaluate working memory.
Measured: 2 month and 4 months after enrollment
CNS Vital Signs adaptions of the Rey visual design learning (RVDL) test.
RVDL is a test that evaluate working memory.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 month and 4 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start5 Jan 2023
- Primary completion6 Jun 2025
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALLStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Phillips, MD,PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550948
- Sponsor's protocol ID
- PBMP
- Other IDs
- NCI-2022-09116
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT05550948
- Acronym / sponsor ID
- PBMP
- Conditions
- ALL, Hodgkin Lymphoma, Cancer, Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alpha tPBM + cognitive training | Experimental | Device: Transcranial photobiomodulation (tPBM) - Mobile Systemthree days per week for a 2-month intervention period (5 ALL and 5 HL) |
| gamma tPBM + cognitive training | Experimental | Device: Transcranial photobiomodulation (tPBM) - Mobile Systemthree days per week for a 2-month intervention period (5 ALL and 5 HL) |
| sham tPBM + cognitive training | Experimental | Device: Transcranial photobiomodulation (tPBM) - Mobile SystemSham stimulations will act as the control for this study three days per week for a 2-month intervention period (5 ALL and 5 HL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Completed treatment for acute lymphoblastic leukemia (ALL) or Hodgkin's Lymphoma (HL) at SJCRH.
- Enrolled in SJLIFE, and less than 21 years of age at diagnosis.
- 18 years of age or older at time of enrollment.
- 2 years or greater post-treatment completion of cancer directed therapy and not currently receiving any cancer directed therapy.
- English language proficiency.
Key exclusion criteria (9 listed)
- Estimated intelligence score less than 80.
- Currently taking medication intended to treat neurocognitive impairment (i.e., stimulants).
- Major psychiatric condition.
- Alcohol abuse in the past year (AUDIT) [greater than or equal to 13 for women and greater than or equal to 15 for men]. The Alcohol Use Disorders Identification Test (AUDIT) will be used to screen for individuals who have active alcohol-use disorders.
- Drug abuse in the past year (DAST-10) [ greater than or equal to 3 for women or men] The Drug Abuse Screen Test (DAST-10) will be used to screen for individuals with active drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial photobiomodulation (tPBM) - Mobile SystemAlso: Vielight portable tPBM NeURO 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. | Device | alpha tPBM + cognitive training, gamma tPBM + cognitive training, sham tPBM + cognitive training |
Primary outcome
Number of participants who completed a two-month trial of paired photobiomodulation (PBM) therapy and cognitive training
Time frame: 4 months after participant enrollment
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).
5 secondary outcomes
CNS Vital Signs adaptions of the Rey auditory verbal learning test (RVLT).
Time frame: 2 month and 4 months after enrollment
CNS Vital Signs adaptions of the Rey visual design learning (RVDL) test.
Time frame: 2 month and 4 months after enrollment
CNS Vital Signs implemented Stroop color and word test.
Time frame: 2 month and 4 months after enrollment
CNS Vital Signs implemented Shifting Attention Test.
Time frame: 2 month and 4 months after enrollment
CNS Vital Signs implementation of the Continuous Performance Test (CPT).
Time frame: 2 month and 4 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for ALL
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Phillips, MD,PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial photobiomodulation (tPBM) - Mobile System in people with ALL and Hodgkin Lymphoma, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who completed a two-month trial of paired photobiomodulation (PBM) therapy and cognitive training (time frame: 4 months after participant enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.