RESEARCH SUMMARY AND CONSENT FORM

TITLE: Ultrasound ‘Brain Massage’ for Memory and Cognitive Impairment- An Open-Label Pilot Study

PRINCIPAL INVESTIGATOR: Dr. Helané Wahbeh, research@noetic.org

FUNDED BY: Institute of Noetic Sciences (IONS)

PURPOSE: This study aims to evaluate the safety and potential benefits of the US Pro2000 ultrasound device in improving memory and cognitive functions in individuals with memory difficulties or cognitive challenges. You are being asked to participate because you have been experiencing such difficulties (or care for someone who does) and have access to the US Pro2000 device.

This study is research-focused and does not replace any current medical therapies or medications prescribed by healthcare providers. The intervention involves the self-administration of a device not typically included in standard memory or cognitive impairment treatment protocols. Unlike clinical treatments that may involve medications or structured therapies, this study’s methodology is exploratory and aims to gather data on the potential benefits of ultrasound for cognitive improvement.

Participants are encouraged to discuss their involvement with their healthcare providers to ensure an integrated approach to care that balances standard treatments and study participation. To be included in the study, participants are required to submit an approval to participate letter from their physician.

PROCEDURES: After completing this informed consent form, you will answer some questions to see if you are eligible for the study. If you are eligible, you will be required to submit a letter from your physician granting their approval for you to participate in the study. Once that is received, you will receive an email with a link to complete the baseline questionnaires, which will ask you about your previous use of the US Pro2000 and memory and mood symptoms you (or care recipient) are currently having.

Device Usage: You or the care recipient will then use the US Pro2000 ultrasound device on the LOW setting. You will apply it through the skull at the area near the right side of the head, just above the ear. You will apply it for five minutes, three times daily, for three weeks, followed by a week off (Please see device instructions for more detailed information). This cycle will continue throughout your participation in the study.

Daily Assessment Form: You will receive an email with the Daily Assessment Form every day, where you will record your US Pro2000 usage the day before and any positive or negative symptoms you are experiencing. You will contact the study staff immediately if you are experiencing any new negative symptoms at research@noetic.org or 707-779-8250.

Monthly Surveys: You will receive a monthly link to complete an online survey asking about your memory, cognitive function, mood, and any new positive or negative symptoms.

Completing the Study: Your participation in the study will continue until you no longer use the US Pro2000, you would like to discontinue your participation, or the study ends in approximately 6 months (whichever comes first).
RISKS: This is a minimal-risk study, as ultrasound has been safely used in medical imaging for decades. Some minor, temporary side effects reported with ultrasound and that you may experience include minor headaches, mood shifts, scalp heating, neck pain, muscle twitches, anxiety, sleepiness, skin itching, or exacerbation of tinnitus. In addition, some people with severe cognitive impairment receiving TUS sometimes experience increased lucidity and thus feelings of confusion or heightened stress or disorientation as their cognitive function improves. Participants are encouraged to report these experiences to the study team immediately so that appropriate guidance and adjustments can be provided. Should any discomfort occur, you are advised to stop the session and consult with the study team immediately. This study is research and does not substitute for professional medical advice or treatment.

BENEFITS: You or the care recipient may or may not experience direct benefits from this study. Potential improvements in cognitive function and quality of life may result from using the device but are not guaranteed.

CONFIDENTIALITY: Methods to maintain confidentiality will adhere to HIPAA standards. Electronic data will be securely stored on password-protected computers, and only authorized research personnel will have access to participant data. We are committed to maintaining your confidentiality; however, if you express thoughts of self-harm, death, or that life is not worth living, we are required by law to report this to ensure your safety and well-being. Our priority is your protection and support.

COSTS: There are no costs or payments associated with participation in this study.

PARTICIPATION: You do not have to join this or any research study. If you join the study and later change your mind, you have the right to quit at any time. If you choose not to join any or all parts of this study or withdraw early, there will be no penalty or loss of benefits to which you are otherwise entitled.

If in the future you decide you no longer want to participate in this research, we will remove your name and any other identifiers from your data, but it will not be destroyed, and we may continue to use it for research.

If you have any questions, concerns, or complaints regarding this study now or in the future, contact Helané Wahbeh, at research@noetic.org. This research is being overseen by an Institutional Review Board (“IRB”). You may talk to the IRB Chair, Garret Yount, Ph.D., by emailing him at gyount@noetic.org if:
• Your questions, concerns, or complaints are not being answered by the research team.
• You want to talk to someone besides the research team.
• You have questions about your rights as a research subject.
• You want to get more information or provide input about this research.

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