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Brain Training + Paced Breathing for Cognitive Impairment (HeartBEAM Trial)
N/A
Waitlist Available
Research Sponsored by University of Southern California
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 measured from blood draws at lab visits on weeks 2, 7, and 12
Awards & highlights
HeartBEAM Trial Summary
This trial will study how daily paced breathing affects learning and amyloid beta levels in older adults aged 50-70. They'll do memory training, breathing exercises and lab visits.
Eligible Conditions
- Age-related Cognitive Decline
- Alzheimer's Disease
- Aging
HeartBEAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured from blood draws at lab visits on weeks 2, 7, and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from blood draws at lab visits on weeks 2, 7, and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in plasma Ab42/40 ratio [ Time Frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12 ]
Change in plasma amyloid beta levels
Secondary outcome measures
Brain training performance on 12 Lumosity games during the breathing intervention (controlling for brain training performance pre intervention)
Change in brain perivascular space volume
Change in hippocampal volume
Other outcome measures
Change in plasma pTau-181/tau ratio [ Time Frame: Measured from blood draws at lab visits on Weeks 2, 7, and 12 ]
Body Weight Changes
HeartBEAM Trial Design
2Treatment groups
Experimental Treatment
Group I: Brain training and paced breathing to stimulate alertnessExperimental Treatment2 Interventions
Group II: Brain training and paced breathing to relaxExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brain training
2023
N/A
~100
Paced breathing
2019
N/A
~150
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,187 Total Patients Enrolled
University of California, IrvineOTHER
542 Previous Clinical Trials
1,921,910 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to speak English very well.You have internal pacing wires in your body.You have had hair implants with staples or metal.You have had a spinal fusion stimulator implanted.You have a condition that would make it difficult for you to do the breathing exercises, such as heart problems, trouble breathing, or difficulty thinking clearly.You practice relaxation techniques, biofeedback, or breathing exercises for more than an hour per week.You have had an eye injury involving metal objects.You are using insulin or an infusion pump.You have an implant that is held in place by a magnet.You have a prosthetic heart valve.You have an artificial limb or joint.You have aortic clips in your body.You have metal implants or wire mesh implants in your body.You have wire sutures or surgical staples from a previous surgery.You have Harrington rods in your spine.You have metal implants in your bones or joints.You are between 50 and 70 years old.You have a neurostimulator.You have a metal clip in your brain to treat an aneurysm.This criterion is not clear. Can you please provide more context or clarify the information?You have a hearing aid that cannot be taken out for an MRI.You can see and hear normally, or with the help of glasses or hearing aids.You have a shunt in your spine or brain.You have been hit by shrapnel, buckshot, or bullets.You have other implants in your body or head.You have a medical device in your body for receiving medications or fluids.This criterion does not contain enough information to be rewritten for a fifth grader. Can you provide more context or details about the criterion?You have metal fragments in your eye, head, ear, or skin.You have played Lumosity games regularly in the last 6 months.You have taken part in studies on controlling your heart rate at the USC Emotion & Cognition Lab.You are afraid of being in small or enclosed spaces.You have worked with metal, such as grinding or shaping it, in your job or hobby.You have a cardiac pacemaker.You have a device called a cardiac defibrillator implanted in your heart.You are a healthy adult who weighs at least 110 pounds.You have electrodes attached to your body, head, or brain.You have intravascular stents or filters.You have a cochlear implant or other ear devices.You have an artificial body part like an eye or a penile prosthesis.You have permanent makeup on your eyelids or eyebrows.You are wearing a wig or toupee that cannot be taken off for an MRI.You have normal vision and hearing, or you use corrective devices to have normal vision and hearing.
Research Study Groups:
This trial has the following groups:- Group 1: Brain training and paced breathing to stimulate alertness
- Group 2: Brain training and paced breathing to relax
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.
Does this study include participants who are younger than twenty years old?
"For this trial, only those aged 50 to 70 are eligible, but there are plenty of other clinical studies for younger and older patients - 45 trials for minors and 1141 trails for seniors."
Answered by AI
Is it still possible for participants to join this experiment?
"According to the clinicaltrials.gov platform, this trial is not currently enrolling participants. Initially posted on October 1st 2022, and last edited 28th of that same month; while no longer actively seeking patients at present time there are 1193 other medical trials recruiting now."
Answered by AI
Who meets the eligibility criteria to become a participant of this research?
"This clinical trial seeks 48 participants afflicted with Alzheimer's disease, who must be between 50-70 years old. Eligible candidates should have the capacity for English fluency, weigh more than 110 pounds, a non-menstruating state which has persisted for at least one year and possess corrected or normal vision/hearing. Additionally, they will need to own a home computer and internet connection in addition to an active email account; access to text messages is also mandatory. Finally, individuals must consent to provide biological samples upon request as well as dedicate up to 60 minutes daily over a span of 12 weeks (inclusive of three lab visits)."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of Southern California
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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