CompletedNot Applicable

Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments

United States8 participantsStarted 2013-01

Plain-language summary

The purpose of this protocol is to (1) Determine whether a one-on-one mindfulness meditation intervention or audio training improves performance on an adaptive communication system that utilizes brain-computer interface (BCI); and (2) Determine whether the intervention reduces stress in subjects with severe speech and physical impairments (SSPI). Hypothesis: The group of subjects randomized to the mindfulness meditation training will improve BCI performance and stress levels more than the audio control group.

Who can participate

Age range

18 Years – 75 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.

Inclusion Criteria: * Have a diagnosis by a neurologist of acquired neuromuscular or neurodevelopmental disorder * be capable of participating in 2-hour experimental interactions * Be literate in English * Be English speaking but not be able to communicate by voice or sign language * Have normal or corrected vision and hearing * Have speech that is understood less than 25% of the time * Have reduced hand function for writing and typing Exclusion Criteria: * Have full ability to communicate verbally and with writing/typing

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Change from Baseline in Working Memory at 8 weeks (post intervention)

Timeframe: Baseline and Endpoint (within 1.5 weeks pre and post intervention)

Trial details

NCT IDNCT01964664

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

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