Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT02615535|
Recruitment Status : Completed
First Posted : November 26, 2015
Results First Posted : December 6, 2019
Last Update Posted : March 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Device: EEG neurofeedback-assisted meditation Device: Non-EEG feedback-assisted meditation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury|
|Actual Study Start Date :||December 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2019|
Experimental: EEG neurofeedback-assisted meditation
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
Device: EEG neurofeedback-assisted meditation
meditation with auditory feedback regarding EEG status
Other Name: MUSE
Active Comparator: Non-EEG feedback-assisted meditation
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Device: Non-EEG feedback-assisted meditation
meditation without auditory feedback regarding EEG status
Other Name: MUSE without EEG feedback
- Change in Neurobehavioral Symptom Inventory [ Time Frame: 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.
- Change in Wechsler Adult Intelligence Scale-IV Digit Span [ Time Frame: 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 Wechsler Adult Intelligence Scale-IV Digit Symbol Coding [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Beck Depression Inventory-II [ Time Frame: 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.
- Change in Cognitive and Affective Mindfulness Scale-Revised [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615535
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital Boston|
|Charlestown, Massachusetts, United States, 02129|
|Principal Investigator:||Mel B Glenn, MD||Spaulding Rehabilitation Hospital|