Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

Mass General Brigham

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Device: EEG neurofeedback-assisted meditation; Device: Non-EEG feedback-assisted meditation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02615535

2015P002184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

EEG neurofeedback-assisted meditation

Experimental group

Description:

EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.

Treatment:

Device: EEG neurofeedback-assisted meditation

Non-EEG feedback-assisted meditation

Active Comparator group

Description:

Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.

Treatment:

Device: Non-EEG feedback-assisted meditation