Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: EEG neurofeedback-assisted meditation
* Device: Non-EEG feedback-assisted meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of mild-moderate traumatic brain injury impaired attention or concentration >1 year since traumatic brain injury ability to participate in neurofeedback and mindfulness meditation daily access to a smart phone on stable dosage of neuropsychological medications with no significant changes planned for the duration of the study no prior history of a meditation practice Exclusion Criteria: severe mental illness or psychological symptoms (severe depression, suicidality, disabling anxiety, PTSD, psychosis, dissociation) significant pre-morbid learning disability current or recent (in past year) history of significant drug or alcohol abuse medical illness severe enough to result in an attentional disorder neurodegenerative disease non-fluency in English.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG neurofeedback-assisted meditation<br>EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. | Device: EEG neurofeedback-assisted meditation<br>* meditation with auditory feedback regarding EEG status<br>* Other names: MUSE;|
| Active Comparator: Non-EEG feedback-assisted meditation<br>Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. | Device: Non-EEG feedback-assisted meditation<br>* meditation without auditory feedback regarding EEG status<br>* Other names: MUSE without EEG feedback;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury