Physical ImpairmentsMSPiNCT01964664
Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments
A study testing Mindfulness Meditation Training and Audio Group in people with Physical Impairments and Cerebral Palsy, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Physical Impairments, Cerebral Palsy, Cerebral Ataxia
- What is being tested?
- Mindfulness Meditation Training and Audio Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have full ability to communicate verbally and with writing/typing
Trial locations and contacts
1 site in 1 country.
United States1 site
Participant Homes
Portland Metropolitan Area, Oregon, 97236
About this study
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.
Read the detailed description
Members of the research team will visit subjects' homes for 9 visits that will each last no longer than 2 hours. During the consenting process, participants may opt out of photograph/video recordings of their visits, and they will also be able to choose whether or not they would like their data to be stored in a repository. At the Initial visit, one or more research assistants will visit participants' homes to go over the consent with them and answer any questions they may have. Participants will then complete a computer-based attention task. For this task, they will watch letters flash quickly on a screen, and then they will be asked a "yes/no" question about each series of letters. The computer task will take 20-60 minutes, and the entire visit will last no longer than 2 hours.
Researchers will return to participants' homes within two weeks to complete a Baseline visit. At this time, the investigators will administer the same computer-based attention task. The investigators will also do an EEG recording during a BCI "mastery task," in which participants will try to spell words by looking at a series of letters presented on computer screen. During the "mastery task," the investigators will take a recording called an electroencephalogram (EEG). Participants will be fitted with a cap (much like a swimming cap) with electrodes (small metal sensors that measure electricity). The investigators will place a small amount of electrode gel on the scalp at each electrode site. The "mastery task" will take no longer than 60 minutes.
After the visit, participants will then be emailed an internet-based survey that takes approximately one hour to complete. They will be asked questions about self-perceived stress, feelings and emotions, sleep, how well they think they can pay attention, and their opinions about meditation. This will take approximately 1 hour to complete.
After completing the online surveys, participants will be randomized to receive either an audio or meditation training. The first training is approximately 2 hours long. If they have been randomly selected to receive the audio training, they will listen to and discuss podcasts with the instructor. If they have been randomly selected to receive the meditation training, they will learn about mindfulness, do an awareness exercise, listen to a guided meditation, and receive mindfulness handouts. They will be given an iPod Touch with either podcasts or guided meditations on it (depending on the group assignment) for the duration of the class, along with headphones and/or speakers.
Participants will be asked to do approximately 30 minutes of practice each day, or as much as they are able. They will be asked to record how much they practice. Though this is optional, many people find it helpful to keep a log of their practice. For others, it may feel too burdensome or infeasible. Participants will be able to choose whether or not they want to keep a record of their practice. The iPod Touch will record when and for how long they listen. At the end of the class, they will be given a CD with all of the guided meditations on it.
If participants receive meditation trainings, the instructor will give them some questions to think about before the next visit. They may contemplate and share about the questions via email to whatever extent they choose. The instructor will respond to their emails if they have any urgent needs and talk with participants about their responses at the audio/meditation training visits. Throughout the study, regardless of which group participants are in, they may choose to communicate however much they like-it could be very little, or they may wish to spend several hours a week emailing reflections, observations, and questions about their audio/meditation practice. This is entirely up to individual participants.
The investigators will go to participants home for five more meditation training sessions. For the meditation group, participants will be asked to do a meditation right before the instructor arrives. Each training session is about 90 minutes long.
After the meditation/audio training has been completed, the investigators will conduct the Endpoint visit, which is the same as the Baseline visit and takes approximately 2 hours. It includes the "mastery task" and the computer-based attention task. After the visit, participants will be emailed the same online questionnaire about stress, emotions, sleep, attention, and meditation. This will take approximately 1 hour to complete. Participants will also be emailed some questions to get their feedback about how the research study went for them. Offering thoughtful responses to the questions will likely take approximately 30 minutes.
After the baseline and endpoint, an online questionnaire will be emailed to the participants. It is a series of several surveys: the Perceived Stress Scale (PSS) is a 10-question instrument that utilizes a likert scale and measures self-perceived stress during the past week. The Positive and Negative Affect Scale (PANAS) will also be administered. It is also 10 questions and uses a likert scale. It consists of words that describe feelings and emotions, and participants are to indicate the extent to which they generally feel that way. The APT-II Attention Questionnaire gathers information about participants' self-perceived ability to pay attention. The Pittsburgh Sleep Quality Index (PSQI) asks questions about sleep. And the Attitudes Toward Study solicits information about participants' thoughts and feelings on meditation (the wording of the Pre- and Post- tests vary only slightly).
- Being tested
- Mindfulness Meditation Training, Audio Group
- Keywords
- Mindfulness, Meditation, acute lateral sclerosis, Cerebral Palsy, Cerebral Ataxia, Locked-in Syndrome
- Medical subject headings
- Cerebral Palsy, Locked-In Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation TrainingBehavioural
6-week, one-on-one meditation training. 90-minute home study visit once per week with research assistant. Learn Mindfulness-Based Cognitive Therapy curriculum and mindfulness techniques, and are asked to practice guided meditations 30-45 minutes each day.
Audio GroupBehavioural
Listen to 30-minute podcasts on a daily basis, and discuss podcasts with research assistant at 90-minute weekly home visits. 6 weeks total.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation training | Experimental | 6-week, one-on-one, mindfulness meditation intervention based on Mindfulness-Based Cognitive Therapy program Receives: Behavioral: Mindfulness Meditation Training |
| Audio Group | Active comparator | 6 weeks of listening to podcasts daily (same length as guided meditations), and discussing podcast content with research assistant during weekly study visits Receives: Behavioral: Audio Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Working Memory at 8 weeks (post intervention)
Computer-based working memory task, classically titled "N-Back" task. Participants watch a series of letters presented on a screen, one after the other, and they are instructed to watch for letters being repeated 1 back (two in a row), 2 back (one letter in between repeat), etc (adjusted according to ability).
Measured: Baseline and Endpoint (within 1.5 weeks pre and post intervention)
Secondary outcomes (2)
Change from Baseline in Perceived Stress Scale at 8 weeks (post intervention)
Measured: Baseline and endpoint, within 1.5 weeks before and after intervention
Change from Baseline in performance on BCI spelling task at 8 weeks (post intervention)
Participants use a brain-computer interface system (with EEG) designed for letter-detection
Measured: Baseline and Endpoint, within 1.5 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ImpairmentsStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Barry Oken, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964664
- Sponsor's protocol ID
- 8912
- Acronym
- MSPi
- Status last verified
- Apr 2017
- First submitted
- 9 Jul 2013
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments
- ClinicalTrials.gov ID
- NCT01964664
- Acronym / sponsor ID
- MSPi / 8912
- Keywords
- Mindfulness, Meditation, acute lateral sclerosis, Cerebral Palsy, Cerebral Ataxia, Locked-in Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Members of the research team will visit subjects' homes for 9 visits that will each last no longer than 2 hours. During the consenting process, participants may opt out of photograph/video recordings of their visits, and they will also be able to choose whether or not they would like their data to be stored in a repository. At the Initial visit, one or more research assistants will visit participants' homes to go over the consent with them and answer any questions they may have. Participants will then complete a computer-based attention task. For this task, they will watch letters flash quickly on a screen, and then they will be asked a "yes/no" question about each series of letters. The computer task will take 20-60 minutes, and the entire visit will last no longer than 2 hours.
Researchers will return to participants' homes within two weeks to complete a Baseline visit. At this time, the investigators will administer the same computer-based attention task. The investigators will also do an EEG recording during a BCI "mastery task," in which participants will try to spell words by looking at a series of letters presented on computer screen. During the "mastery task," the investigators will take a recording called an electroencephalogram (EEG). Participants will be fitted with a cap (much like a swimming cap) with electrodes (small metal sensors that measure electricity). The investigators will place a small amount of electrode gel on the scalp at each electrode site. The "mastery task" will take no longer than 60 minutes.
After the visit, participants will then be emailed an internet-based survey that takes approximately one hour to complete. They will be asked questions about self-perceived stress, feelings and emotions, sleep, how well they think they can pay attention, and their opinions about meditation. This will take approximately 1 hour to complete.
After completing the online surveys, participants will be randomized to receive either an audio or meditation training. The first training is approximately 2 hours long. If they have been randomly selected to receive the audio training, they will listen to and discuss podcasts with the instructor. If they have been randomly selected to receive the meditation training, they will learn about mindfulness, do an awareness exercise, listen to a guided meditation, and receive mindfulness handouts. They will be given an iPod Touch with either podcasts or guided meditations on it (depending on the group assignment) for the duration of the class, along with headphones and/or speakers.
Participants will be asked to do approximately 30 minutes of practice each day, or as much as they are able. They will be asked to record how much they practice. Though this is optional, many people find it helpful to keep a log of their practice. For others, it may feel too burdensome or infeasible. Participants will be able to choose whether or not they want to keep a record of their practice. The iPod Touch will record when and for how long they listen. At the end of the class, they will be given a CD with all of the guided meditations on it.
If participants receive meditation trainings, the instructor will give them some questions to think about before the next visit. They may contemplate and share about the questions via email to whatever extent they choose. The instructor will respond to their emails if they have any urgent needs and talk with participants about their responses at the audio/meditation training visits. Throughout the study, regardless of which group participants are in, they may choose to communicate however much they like-it could be very little, or they may wish to spend several hours a week emailing reflections, observations, and questions about their audio/meditation practice. This is entirely up to individual participants.
The investigators will go to participants home for five more meditation training sessions. For the meditation group, participants will be asked to do a meditation right before the instructor arrives. Each training session is about 90 minutes long.
After the meditation/audio training has been completed, the investigators will conduct the Endpoint visit, which is the same as the Baseline visit and takes approximately 2 hours. It includes the "mastery task" and the computer-based attention task. After the visit, participants will be emailed the same online questionnaire about stress, emotions, sleep, attention, and meditation. This will take approximately 1 hour to complete. Participants will also be emailed some questions to get their feedback about how the research study went for them. Offering thoughtful responses to the questions will likely take approximately 30 minutes.
After the baseline and endpoint, an online questionnaire will be emailed to the participants. It is a series of several surveys: the Perceived Stress Scale (PSS) is a 10-question instrument that utilizes a likert scale and measures self-perceived stress during the past week. The Positive and Negative Affect Scale (PANAS) will also be administered. It is also 10 questions and uses a likert scale. It consists of words that describe feelings and emotions, and participants are to indicate the extent to which they generally feel that way. The APT-II Attention Questionnaire gathers information about participants' self-perceived ability to pay attention. The Pittsburgh Sleep Quality Index (PSQI) asks questions about sleep. And the Attitudes Toward Study solicits information about participants' thoughts and feelings on meditation (the wording of the Pre- and Post- tests vary only slightly).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation training | Experimental | Behavioral: Mindfulness Meditation Training6-week, one-on-one, mindfulness meditation intervention based on Mindfulness-Based Cognitive Therapy program |
| Audio Group | Active comparator | Behavioral: Audio Group6 weeks of listening to podcasts daily (same length as guided meditations), and discussing podcast content with research assistant during weekly study visits |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Have full ability to communicate verbally and with writing/typing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation Training6-week, one-on-one meditation training. 90-minute home study visit once per week with research assistant. Learn Mindfulness-Based Cognitive Therapy curriculum and mindfulness techniques, and are asked to practice guided meditations 30-45 minutes each day. | Behavioural | Mindfulness meditation training |
| Audio GroupListen to 30-minute podcasts on a daily basis, and discuss podcasts with research assistant at 90-minute weekly home visits. 6 weeks total. | Behavioural | Audio Group |
Primary outcome
Change from Baseline in Working Memory at 8 weeks (post intervention)
Time frame: Baseline and Endpoint (within 1.5 weeks pre and post intervention)
Computer-based working memory task, classically titled "N-Back" task. Participants watch a series of letters presented on a screen, one after the other, and they are instructed to watch for letters being repeated 1 back (two in a row), 2 back (one letter in between repeat), etc (adjusted according to ability).
2 secondary outcomes
Change from Baseline in Perceived Stress Scale at 8 weeks (post intervention)
Time frame: Baseline and endpoint, within 1.5 weeks before and after intervention
Change from Baseline in performance on BCI spelling task at 8 weeks (post intervention)
Time frame: Baseline and Endpoint, within 1.5 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Oken, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation Training and Audio Group in people with Physical Impairments and Cerebral Palsy, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Working Memory at 8 weeks (post intervention) (time frame: Baseline and Endpoint (within 1.5 weeks pre and post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.