Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

Not Applicable

Completed

Conditions: Traumatic Brain Injury

Interventions: Device: EEG neurofeedback-assisted meditation
Device: Non-EEG feedback-assisted meditation

Registration Number: NCT02615535

Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EEG neurofeedback-assisted meditation	EEG neurofeedback-assisted meditation	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
Non-EEG feedback-assisted meditation	Non-EEG feedback-assisted meditation	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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 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 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 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 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.