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Transcranial Photobiomodulation for Childhood Cancer Survivorship
N/A
Recruiting
Led By Nicholas Phillips, MD,PhD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 month and 4 months after enrollment
Awards & highlights
Study Summary
This trial is looking at whether using home-based tPBM (transcranial pulsed magnetic stimulation) paired with remote cognitive training can help improve cognitive performance in survivors of ALL (acute lymphoblastic leukemia) and HL (Hodgkin's lymphoma).
Who is the study for?
This trial is for adults who had childhood cancer (ALL or HL), are now over 18, finished treatment at least 2 years ago, and have cognitive issues. They must speak English, have WiFi access, and not be on other cognitive trials or medications for neurocognitive impairment. Pregnant women and those with major psychiatric conditions, recent substance abuse, certain medical histories or low intelligence scores cannot join.Check my eligibility
What is being tested?
The study tests if a home-based Transcranial Photobiomodulation (tPBM) device paired with remote cognitive training can improve thinking skills in survivors of ALL and HL. It looks into how different tPBM frequencies affect cognition and self-reported symptoms like sleep quality and mood.See study design
What are the potential side effects?
Potential side effects of tPBM may include discomfort at the application site, headache, fatigue or changes in mood. However, as this is a non-invasive therapy using light to stimulate brain cells it's generally considered safe with minimal risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 month and 4 months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 month and 4 months after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who completed a two-month trial of paired photobiomodulation (PBM) therapy and cognitive training
Secondary outcome measures
CNS Vital Signs adaptions of the Rey auditory verbal learning test (RVLT).
Denture Design
Central Nervous System
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: sham tPBM + cognitive trainingExperimental Treatment1 Intervention
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)
Group II: gamma tPBM + cognitive trainingExperimental Treatment1 Intervention
three days per week for a 2-month intervention period (5 ALL and 5 HL)
Group III: alpha tPBM + cognitive trainingExperimental Treatment1 Intervention
three days per week for a 2-month intervention period (5 ALL and 5 HL)
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,583 Total Patients Enrolled
Nicholas Phillips, MD,PhDPrincipal InvestigatorSt. Jude Children's Research Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for brain function issues.I was diagnosed before turning 21 and am enrolled in SJLIFE.I finished treatment for ALL or Hodgkin's Lymphoma at SJCRH.I am 18 years old or older.I have a neurological or genetic condition affecting my thinking or memory not related to my cancer.I am not pregnant or breastfeeding.I finished my cancer treatment over 2 years ago and am not on any current cancer therapy.
Research Study Groups:
This trial has the following groups:- Group 1: alpha tPBM + cognitive training
- Group 2: gamma tPBM + cognitive training
- Group 3: sham tPBM + cognitive training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this clinical trial currently still underway?
"According to data presented on clinicaltrials.gov, this medical study is not currently looking for new participants as the last update was posted on November 7th 2022. Nonetheless, there are 636 other trials in need of volunteers at the moment."
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