Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| InteraXon, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Spaulding Rehabilitation Hospital is conducting a research study evaluating the effectiveness of the brain-training product, MUSE, an EEG-guided neurofeedback device designed to assist in cultivating a relaxed, attentive state of mind during meditation. The investigators study aims to evaluate whether such a tool could be useful in treating persistent traumatic brain injury symptoms such as inattention, impulsivity, irritability, or dysregulated mood.
Twenty subjects in total will participate in this study. Subjects will be randomized to focused-attention meditation training with or without the neurofeedback device, MUSE. Subjects will be asked to practice ~10 min of daily meditation for 6-8 weeks. Neuropsychological testing will be performed at the beginning of the study and after six weeks of training. At this time point, those randomized to the non-MUSE group will be given a device and asked to train for an additional two weeks. At the conclusion of the study, all subjects will also undergo a brief telephone or in-person exit interview regarding their experiences using the MUSE device.
Primary endpoint: change in Neurobehavioral Symptom Inventory
Secondary endpoints: change in the following: Wechsler Adult Intelligence Scale-IV Digit Span and Symbol-Digit Coding, Trail-Making Test, Beck Anxiety Inventory, Beck Depression Inventory, Cognitive and Affective Mindfulness Scale-Revised, percentage of EEG activity associated with alpha, beta, or theta activity.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EEG neurofeedback-assisted meditation | Experimental | EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. |
|
| Non-EEG feedback-assisted meditation | Active Comparator | Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG neurofeedback-assisted meditation | Device | meditation with auditory feedback regarding EEG status |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurobehavioral Symptom Inventory | Measures common symptoms after head injury. This scales ranges from 0-4 on 22 items, for a minimum score of 0 and a maximum score of 88. Higher scores mean a greater severity of symptoms. | baseline and six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wechsler Adult Intelligence Scale-IV Digit Span | Tests participants digit span, repeating forward sequences of digits from 2 to 8. Scale ranges from 0 to 16. Higher scores mean a better outcome. | baseline and six weeks |
| Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mel B Glenn, MD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital Boston | Charlestown | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24109463 | Background | Brandmeyer T, Delorme A. Meditation and neurofeedback. Front Psychol. 2013 Oct 7;4:688. doi: 10.3389/fpsyg.2013.00688. eCollection 2013. No abstract available. | |
| 21183265 | Background | Chiesa A, Calati R, Serretti A. Does mindfulness training improve cognitive abilities? A systematic review of neuropsychological findings. Clin Psychol Rev. 2011 Apr;31(3):449-64. doi: 10.1016/j.cpr.2010.11.003. Epub 2010 Dec 1. |
Not provided
Not provided
If participants request their outcome data, we will provide this to them with a brief discussion of its meaning and limitations on interpretation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EEG Neurofeedback-assisted Meditation | EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status |
| FG001 | Non-EEG Feedback-assisted Meditation | Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EEG Neurofeedback-assisted Meditation | EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status |
| BG001 | Non-EEG Feedback-assisted Meditation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Neurobehavioral Symptom Inventory | Measures common symptoms after head injury. This scales ranges from 0-4 on 22 items, for a minimum score of 0 and a maximum score of 88. Higher scores mean a greater severity of symptoms. | Posted | Mean | Standard Error | units on a scale | baseline and six weeks |
|
Adverse effects from meditation were not anticipated. Subjects practiced meditation for six weeks each. If adverse effects occurred during the six weeks, they contacted our group. At our post-intervention assessment at six weeks, we asked specifically about adverse events. Adverse events were not monitored beyond the intervention period of six weeks.
Definitions are consistent.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EEG Neurofeedback-assisted Meditation | EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ginger Polich | Spaulding Rehabilitation Hospital | 617 952 5000 | ginger.polich@mgh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2016 | Oct 4, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-EEG feedback-assisted meditation | Device | meditation without auditory feedback regarding EEG status |
|
|
A subject is provided with a key matching nine numbers to nine unique symbols. Numbers are then provided in random order and subjects have 120 seconds to match as many numbers with symbols as possible. All correct responses are scored. Scores range from 0 to 135. Scores are later scaled from 1 to 19. Higher scores mean a better outcome. |
| baseline and six weeks |
| Change in Trail Making Test | Subjects are asked to sequence numbers and letters represented on a page as quickly as then can. Results are measured in seconds, ranging from 0 (hypothetically) to an infinite number (hypothetically). Results are scaled from 1 to 19. Lower scores mean a better outcome. | baseline and six weeks |
| Change in Beck Anxiety Inventory | Subjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome. | baseline and six weeks |
| Change in Beck Depression Inventory-II | Subjects respond to questions on a Likert scale from 0-3 regarding depressive symptoms. There are 21 items. Scores range from 0-63. Lower scores mean a better outcome. | baseline and six weeks |
| Change in Cognitive and Affective Mindfulness Scale-Revised | Subjects answer questions regarding mindfulness on a Likert Scale from 1-4. There are twelve questions total. Scores range from 4-48. Higher scores mean a better outcome. | baseline and six weeks |
| Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device | Change in "percent Calm" as determined by Muse device. Equations behind this algorithm to determine "Calm" are proprietary and were not shared by the device manufacturer. Ranges from 0% to 100%. Higher scores mean a better outcome. | baseline and at six weeks |
| 21440699 | Background | Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015. |
| 20350028 | Background | Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555. |
| 32783645 | Derived | Polich G, Gray S, Tran D, Morales-Quezada L, Glenn M. Comparing focused attention meditation to meditation with mobile neurofeedback for persistent symptoms after mild-moderate traumatic brain injury: a pilot study. Brain Inj. 2020 Aug 23;34(10):1408-1415. doi: 10.1080/02699052.2020.1802781. Epub 2020 Aug 12. |
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Change in Wechsler Adult Intelligence Scale-IV Digit Span | Tests participants digit span, repeating forward sequences of digits from 2 to 8. Scale ranges from 0 to 16. Higher scores mean a better outcome. | Posted | Mean | Standard Error | units on a scale | baseline and six weeks |
|
|
|
| Secondary | Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding | A subject is provided with a key matching nine numbers to nine unique symbols. Numbers are then provided in random order and subjects have 120 seconds to match as many numbers with symbols as possible. All correct responses are scored. Scores range from 0 to 135. Scores are later scaled from 1 to 19. Higher scores mean a better outcome. | Posted | Mean | Standard Error | units on a scale | baseline and six weeks |
|
|
|
| Secondary | Change in Trail Making Test | Subjects are asked to sequence numbers and letters represented on a page as quickly as then can. Results are measured in seconds, ranging from 0 (hypothetically) to an infinite number (hypothetically). Results are scaled from 1 to 19. Lower scores mean a better outcome. | Posted | Mean | Standard Error | units on a scale | baseline and six weeks |
|
|
|
| Secondary | Change in Beck Anxiety Inventory | Subjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome. | Posted | Mean | Standard Error | score on a scale | baseline and six weeks |
|
|
|
| Secondary | Change in Beck Depression Inventory-II | Subjects respond to questions on a Likert scale from 0-3 regarding depressive symptoms. There are 21 items. Scores range from 0-63. Lower scores mean a better outcome. | Posted | Mean | Standard Error | score on a scale | baseline and six weeks |
|
|
|
| Secondary | Change in Cognitive and Affective Mindfulness Scale-Revised | Subjects answer questions regarding mindfulness on a Likert Scale from 1-4. There are twelve questions total. Scores range from 4-48. Higher scores mean a better outcome. | Posted | Mean | Standard Error | score on a scale | baseline and six weeks |
|
|
|
| Secondary | Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device | Change in "percent Calm" as determined by Muse device. Equations behind this algorithm to determine "Calm" are proprietary and were not shared by the device manufacturer. Ranges from 0% to 100%. Higher scores mean a better outcome. | Posted | Mean | Standard Error | percentage of "Calm" | baseline and at six weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Non-EEG Feedback-assisted Meditation | Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |