Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury



Status:Active, not recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 65
Updated:9/14/2017
Start Date:December 2015
End Date:March 2018

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

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.

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.

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.
We found this trial at
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Charlestown, Massachusetts 02129
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Charlestown, MA
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