Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEEG neurofeedback-assisted meditation
meditation with auditory feedback regarding EEG status
DEVICENon-EEG feedback-assisted meditation
meditation without auditory feedback regarding EEG status
Sponsors
InteraXon, Inc.
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. history of mild-moderate traumatic brain injury 2. impaired attention or concentration 3. \>1 year since traumatic brain injury 4. ability to participate in neurofeedback and mindfulness meditation 5. daily access to a smart phone 6. on stable dosage of neuropsychological medications with no significant changes planned for the duration of the study 7. no prior history of a meditation practice
Exclusion criteria
1. severe mental illness or psychological symptoms (severe depression, suicidality, disabling anxiety, PTSD, psychosis, dissociation) 2. significant pre-morbid learning disability 3. current or recent (in past year) history of significant drug or alcohol abuse 4. medical illness severe enough to result in an attentional disorder 5. neurodegenerative disease 6. non-fluency in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neurobehavioral Symptom Inventory | baseline and six weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding | baseline and six weeks | 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. |
| Change in Trail Making Test | baseline and six weeks | 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. |
| Change in Beck Anxiety Inventory | baseline and six weeks | Subjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome. |
| Change in Wechsler Adult Intelligence Scale-IV Digit Span | baseline and six weeks | 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. |
| Change in Cognitive and Affective Mindfulness Scale-Revised | baseline and six weeks | 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. |
| Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device | baseline and at six weeks | 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. |
| Change in Beck Depression Inventory-II | baseline and six weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | EEG Neurofeedback-assisted Meditation | Non-EEG Feedback-assisted Meditation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 49.3 years STANDARD_DEVIATION 3.6 | 41.4 years STANDARD_DEVIATION 4.7 | 45.4 years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: baseline and six weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEG Neurofeedback-assisted Meditation | Change in Neurobehavioral Symptom Inventory | baseline | 35.2 units on a scale | Standard Error 3 |
| EEG Neurofeedback-assisted Meditation | Change in Neurobehavioral Symptom Inventory | 6 weeks | 27.7 units on a scale | Standard Error 2.8 |
| Non-EEG Feedback-assisted Meditation | Change in Neurobehavioral Symptom Inventory | baseline | 33.1 units on a scale | Standard Error 5.1 |
| Non-EEG Feedback-assisted Meditation | Change in Neurobehavioral Symptom Inventory | 6 weeks | 24.6 units on a scale | Standard Error 3.9 |
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.
Time frame: baseline and six weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEG Neurofeedback-assisted Meditation | Change in Beck Anxiety Inventory | baseline | 15.9 score on a scale | Standard Error 1.9 |
| EEG Neurofeedback-assisted Meditation | Change in Beck Anxiety Inventory | six weeks | 11.5 score on a scale | Standard Error 1.9 |
| Non-EEG Feedback-assisted Meditation | Change in Beck Anxiety Inventory | baseline | 18.8 score on a scale | Standard Error 4.6 |
| Non-EEG Feedback-assisted Meditation | Change in Beck Anxiety Inventory | six weeks | 8.5 score on a scale | Standard Error 1.8 |
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.
Time frame: baseline and six weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEG Neurofeedback-assisted Meditation | Change in Beck Depression Inventory-II | baseline | 19.9 score on a scale | Standard Error 3.6 |
| EEG Neurofeedback-assisted Meditation | Change in Beck Depression Inventory-II | six weeks | 13.1 score on a scale | Standard Error 3.1 |
| Non-EEG Feedback-assisted Meditation | Change in Beck Depression Inventory-II | baseline | 17 score on a scale | Standard Error 3.5 |
| Non-EEG Feedback-assisted Meditation | Change in Beck Depression Inventory-II | six weeks | 9.9 score on a scale | Standard Error 2.8 |
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.
Time frame: baseline and six weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEG Neurofeedback-assisted Meditation | Change in Cognitive and Affective Mindfulness Scale-Revised | baseline | 24.2 score on a scale | Standard Error 2 |
| EEG Neurofeedback-assisted Meditation | Change in Cognitive and Affective Mindfulness Scale-Revised | six weeks | 27.3 score on a scale | Standard Error 1.6 |
| Non-EEG Feedback-assisted Meditation | Change in Cognitive and Affective Mindfulness Scale-Revised | baseline | 24.7 score on a scale | Standard Error 1.8 |
| Non-EEG Feedback-assisted Meditation | Change in Cognitive and Affective Mindfulness Scale-Revised | six weeks | 28.3 score on a scale | Standard Error 2.1 |
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.
Time frame: baseline and at six weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEG Neurofeedback-assisted Meditation | Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device | baseline | 49.7 percentage of Calm | Standard Error 5.6 |
| EEG Neurofeedback-assisted Meditation | Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device | six weeks | 57.7 percentage of Calm | Standard Error 7.6 |
| Non-EEG Feedback-assisted Meditation | Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device | baseline | 32 percentage of Calm | Standard Error 7.8 |
| Non-EEG Feedback-assisted Meditation | Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device | six weeks | 43.7 percentage of Calm | Standard Error 9.9 |
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.
Time frame: baseline and six weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEG Neurofeedback-assisted Meditation | Change in Trail Making Test | baseline | 10.9 units on a scale | Standard Error 1 |
| EEG Neurofeedback-assisted Meditation | Change in Trail Making Test | six weeks | 12.3 units on a scale | Standard Error 0.8 |
| Non-EEG Feedback-assisted Meditation | Change in Trail Making Test | baseline | 11.9 units on a scale | Standard Error 0.4 |
| Non-EEG Feedback-assisted Meditation | Change in Trail Making Test | six weeks | 12.7 units on a scale | Standard Error 0.4 |
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.
Time frame: baseline and six weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEG Neurofeedback-assisted Meditation | Change in Wechsler Adult Intelligence Scale-IV Digit Span | baseline | 10.4 units on a scale | Standard Error 0.7 |
| EEG Neurofeedback-assisted Meditation | Change in Wechsler Adult Intelligence Scale-IV Digit Span | six weeks | 10.9 units on a scale | Standard Error 0.6 |
| Non-EEG Feedback-assisted Meditation | Change in Wechsler Adult Intelligence Scale-IV Digit Span | baseline | 11.2 units on a scale | Standard Error 1 |
| Non-EEG Feedback-assisted Meditation | Change in Wechsler Adult Intelligence Scale-IV Digit Span | six weeks | 11.8 units on a scale | Standard Error 0.8 |
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.
Time frame: baseline and six weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EEG Neurofeedback-assisted Meditation | Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding | baseline | 11.6 units on a scale | Standard Error 1.2 |
| EEG Neurofeedback-assisted Meditation | Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding | six weeks | 13.1 units on a scale | Standard Error 1.1 |
| Non-EEG Feedback-assisted Meditation | Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding | baseline | 11.1 units on a scale | Standard Error 0.9 |
| Non-EEG Feedback-assisted Meditation | Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding | six weeks | 12.5 units on a scale | Standard Error 0.8 |