The purpose of this study is to assess the safety and feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to acquired brain injury, Long COVID, traumatic brain injury, myalgic encephalomyelitis (ME/CFS), and other neurodegenerative diagnoses including but not limited to Alzheimer's disease and to collect data on safety and efficacy to inform the design of larger clinical studies.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
IncInclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Any sex/gender
* 16 years of age or older
* English Speaking
* Experiencing symptoms of at least self-reported mild cognitive impairment associated with a confirmed diagnosis of a condition such as Long COVID, Traumatic Brain Injury, other Acquired Brain Injuries, and other neurodegenerative diagnoses including but not limited to Alzheimer's disease
* Individuals of childbearing age agreeing to use a highly effective form of birth control for the duration of their participation
* Willing and able to sign informed consent or have a parent or LAR able to sign informed consent form
* Willing and able to attend all study visits virtually or in person
Exclusion Criteria:
Individual who meets any of the following criteria will be excluded from participation in this study:
* Enrollment in another interventional clinical trial in the last 90 days or during the study period
* Change in anti-depressant or other psychoactive medication or dose in the last 90 days
* Cranially implanted devices or metal
* Pacemaker
* History of seizure disorder
* Pregnant or plan to become pregnant during the study as indicated by proof of a positive pregnancy test
* Inability to achieve appropriate positioning of the study device on the head
* Any medical, psychiatric, or neurological condition, or concurrent treatment, that in the opinion of the Principal Investigato…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to wait for it or pursue other options in the meantime?
2The main thing this trial is measuring is whether people actually complete their prescribed device sessions, not whether the device improves cognition — what does that tell us about how early-stage this research is, and what would be unknown about safety and effectiveness if I were to participate?
3Since this is a Phase NA open-label trial for acquired or traumatic brain injury with cognitive dysfunction, does my specific diagnosis and injury history make me a realistic candidate to discuss with the study team?
4Because it's an open-label design, everyone knows they're receiving the device treatment — how might that affect how we interpret any improvements I might notice, and is there a standard-of-care rehabilitation approach I should be pursuing regardless?
5What would the day-to-day commitment look like in terms of attending device sessions, and given where I am in my recovery, is this the right time to take on a clinical trial's schedule?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants who complete prescribed device sessions