Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury
Phase: NA
Conditions: Traumatic Brain Injury
Sponsor: Spaulding Rehabilitation Hospital

Neurofeedback-enhanced mindfulness meditation for the treatment of affective 
and attentional disturbances in traumatic brain injury patients  
 
 
ID: 2015P002184 
 
Spaulding Rehabilitation Hospital 
Mel Glenn 
Date: 11/1/16 
 
 

Background and Significance 
Historical Background:  
Mindfulness meditation (MM) involves the non-judgmental paying attention to moment-to-
moment experience. In contemporary, Western society, the practice is now widely used to 
improve psychological well-being, treat anxiety and mood disturbances, decrease stress and 
train attention, among other uses. A substantial and ever-growing scientific evidence base 
supports many of these efforts. Numerous studies demonstrate MM’s capacity for the 
attenuation of psychological distress (Keng et al. 2011). Meta-analyses have demonstrated how 
the practices can significantly impact symptoms of anxiety and depression (Hofmann et al. 
2011). A handful of studies have also evaluated the impact of MM on various facets of attention, 
though results have been less consistently favorable (Chiesa 2011).  
 
Given its ability to improve stress and mood and possibility inattention, MM appears especially 
well suited to treat persistent symptoms of mild traumatic brain injury (mTBI). Every year in the 
United States, more than 1.4 million people suffer from TBI, 75% of which are considered mild 
(CDC). While the majority of patients with mTBI make a full recovery within the first year after 
head injury, a substantial percentage of patients, estimated between 5% (Iverson 2005) to 15% 
(Alves 1993), go on to have persistent physical and psychological symptoms, such as 
headache, dizziness/vertigo, impaired balance, memory deficits, inattention, slowed processing, 
hypersomnolence, fatigue, insomnia, depression, anxiety, and irritability (Glenn and Herman 
2007). A growing body of literature has begun exploring the utility of MM in the treatment of 
mTBI symptoms, with positive results now accumulating for its impact on quality of life and 
depressive symptoms (Bedard et al. 2005), and possibly attention (Azulay et al. 2013; McHugh 
and Wood 2013).  
 
Meditation can prove challenging, however, especially for the neurologically injured who suffer 
from persistent inattention and distractibility. A recently launched consumer product, “MUSE: the 
brain-sensing headband” aims to facilitate medication practice, cueing users into the success of 
their technique and helping them stay motivated to sustain a consistent practice 
(www.choosemuse.com). MUSE is a neurofeedback (NF) device that uses frontotemporal scalp 
electrodes to measure synchronous, postsynaptic potentials in the cortex represented as 
oscillatory EEG waves. These waves are mathematically transformed into an auditory 
neurofeedback signal that is fed back to users, training them to maximize relaxed, attentive and 
minimize distracted states of mind. Neurofeedback generally works through operant 
conditioning, enabling individuals to learn to control and/or change their brain activity over 
extended practice. User’s performance and progress is tracked over time on a mobile device. 
By providing users with real-time feedback and gamifying their practice, MUSE aims to make 
meditation a more appealing and sustainable practice. These features may be of special 
relevance for the mTBI population.  
 
In our study, we wish to evaluate the efficacy of a simple MM intervention in chronic TBI 
patients, evaluating its potential impact on anxiety, depression, and attention. Our study will 
involve two groups of patients, those who practice regular MM and those whose MM is 
enhanced by NF. We hypothesize that MM both with and without NF-assistance will lead to 
improvements in anxiety and depression scales. We further hypothesize that by optimizing a 
MM practice, MM-NF will lead to improvements in attention, as well as improved receptivity of 
the practice overall.    
 
Previous clinical studies of MM on anxiety and mood:  
In the last several decades, numerous studies have established the efficacy of MM in the 
treatment of mood disorders. A recent meta-analysis concluded that mindfulness-based 
therapies can reduce symptoms of anxiety and depression, with large effect size in patients with 
anxiety and depressive disorders and moderate effect size in the more general population 
(Hofmann 2010). The benefits of MM on anxiety and mood would likely extend to symptoms 

within the mTBI population as well. Mood disturbances following TBI is very common, with 
cumulative rates of depression estimated at 61% and anxiety at 70% (Hibbard et al. 1998).  
 
A handful of studies have evaluated the impact of MM on mood disturbances in TBI. A pilot 
study employing a group mindfulness-based intervention in a TBI population showed 
improvements in quality of life after 12 weeks (Bedard et al. 2003). Improvements were 
maintained at follow-up one year later (Bedard et al. 2005), however no control patients were 
included in this latter study, making passage of time and/or placebo effects a possible 
explanation for the findings.  
 
Attention in TBI—cognitive training and mindfulness-based training:  
Attention training for the chronic TBI population is a domain of cognitive rehabilitation that has 
received a lot of consideration in recent years. Several large reviews and meta-analyses 
(Cicirone 2011; Ponsford 2014) similarly conclude that chronic, post-TBI attentional deficits can 
be at least partially rehabilitated through repetitive, task-based training.  
 
Within the TBI literature, the modality with the most robust and promising literature is a cognitive 
strategy, Attention-Process Training (APT), a computer training game designed for patients with 
acquired brain injury that aims to rehab multiple subcomponents of attention. The concern with 
APT is despite improved performance on program tasks, training may not transfer to novel 
cognitive tests (Zickefoose, et al. 2013). Two small studies, however, have shown that 
improvements on APT do transfer to novel attentional tasks as measured by standard 
neuropsychological tests (Palmese et al. 2000; Pero et al. 2006). A more rigorous study of APT 
is currently being undertaken (Bartfai et al. 2014).  
 
A growing body of evidence has examined the role of mindfulness meditation as a method of 
attention training in adults. Contemporary definitions of meditation define the practice as 
“attentional regulatory training” (Lutz et al. 2008). Studies have shown improvements following 
MM in executive attention (Tang et al. 2007; Wenk-Sormaz 2005; Ainsworth 2013) and 
attentional discrimination (Semple et al. 2010). Such studies compare pre- versus post-MM 
outcomes on objective neuropsychological tests—suggesting that MM does in fact transfer to 
novel tasks. On the contrary, a substantial number of studies have also failed to show MM to be 
beneficial to attention training (Anderson et al. 2007; MacCoon et al. 2014).  
 
A smaller subset of studies have evaluated the impact of meditation on attention among TBI 
patients. Cognitive benefits of MM in a TBI population have been demonstrated on an over-
selectivity task (McHugh and Wood 2013) and executive aspects of attention (Azulay et al. 
2013). In a more rigorously designed RCT, however, MM practice in a TBI group was not 
associated with improvements on attention tasks (McMillan et al. 2002). According to the major 
cognitive rehabilitation reviews for TBI, the literature on MM for attentional training is not robust 
enough to recommend outside of a research protocol at this time (Ponsford et al. 2014). We feel 
that by using NF to assist a practice of MM, MM would be more likely to significantly improve 
attention.   
 
Neurofeedback: 
NF has been studied as a treatment numerous neurological and psychological disorders 
including anxiety and depression (Hammond et al. 2005), and ADHD (Vollebregt et al. 2014). 
Research shows that when participants are shown their brain waves in real-time, they are able 
to alter their frequency. Whether or not this translates to meaningful clinical impact is a matter of 
debate. A review on NF for the chronic TBI population cited multiple studies demonstrating the 
utility of using NF for the treatment of attention, impulse control, executive functioning, and 
processing speed, however the authors remarked that most studies included in this review 
lacked rigor (May et al. 2013). In fact, some strongly argue that in general, the benefit of NF as 
more generally applied to all clinical populations represents non-specific effects related to 

placebo effects and expectancy (Thibault et al. 2015). Currently, the FDA has only approved NF 
devices as a relaxation tool.  
 
NF and MM have many similarities—both can be used to train relaxed, focused mental states, 
improve attention, and build emotional control—and differences—MM being “self-regulated” and 
NF “machine-aided” (Brandmeyer and Delorme 2013). The use of NF as a tool to enhance MM 
by detecting mind-wandering right as it occurs, is a novel concept.  
 
Rationale behind the proposed research and potential benefits to patients and/or society:  
MM represents a safe strategy for treating mood and anxiety disorders and potentially aspects 
of attentional performance in a mTBI population. However due to this population’s post-
traumatic cognitive impairments, MM is a less accessible therapeutic strategy than it otherwise 
would be. MUSE, through its provision of NF and gamification, has the potential to help TBI 
patients initiate, sustain, and maintain a meditation practice. If MUSE outperforms MM on 
affective or cognitive outcome measurements, this study could function as a pilot study, 
informing future investigations of the product. If MUSE ultimately holds up in more rigourous 
studies, it should be recommended as a therapeutic tool to mTBI patients. If on the other hand, 
MUSE does not show any benefits over a regular practice of MM, the device would not be 
considered cost-effective and should therefore not be recommended to mTBI patients.  
 
Specific Aims: 
Aim 1: Evaluate within group differences, whether a daily, six-week practice of NF-MM or MM or 
a no-treatment control leads to pre- versus post-treatment changes in affective, cognitive, or 
mindfulness-associated variables.  
 
Aim 2: Evaluate across-group differences, whether NF-MM outperforms MM in affective, 
cognitive, or mindfulness-associated variables, or whether NF-MM or MM differ from a no-
treatment control group.  
 
Aim 3: Evaluate the change in mindful attention (as measured by EEG) between NF-MM and 
MM groups and the no-treatment control group at the end of the intervention.   
 
Aim 4: Evaluate the relationship between the degree of mindful attention (as measure by EEG) 
and affective and cognitive variables across NF-MM/MM groups as well as the no-treatment 
control group.  
 
Aim 5: Evaluate acceptability of and attitudes toward NF-MM in TBI patients.  
 
Subject Selection 
Inclusion criteria: 1) history of mild-moderate TBI (per ACRM guidelines), 2) significant 
complaint of impaired attention or concentration, 3) ages 18-65, 4) >1 year since TBI, 5) 
significant cognitive function to participate in neurofeedback and mindfulness meditation, 6) has 
daily access to a smart phone, 7) no significant medication changes planned for the duration of 
the study, 8) has not had a significant meditation practice in the past.   
 
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.  
 
Source of subjects/patients: Subjects will be recruited from a variety of settings including 
outpatient clinics and related clinical research projects of various clinicians including MDs, 

SLPs, psychologists, and LCSWs at SRH and MGH, local TBI support groups, including BABIS 
(Boston Acquired Brain Injury Support Group), or the general population.  
 
Recruitment methods: Recruitment methods will include word of mouth and dear colleague 
letters, email, list servs postings, flyers, as well as online posting on the partners RSVP for 
Health, Process Notes from MGH Psychiatry, Spaulding Weekly Spotlight publication, MA psych 
association listserv, and various social media outlets including LinkedIn and Facebook. The 
actual documents disseminated through these various above listed avenues will include all 
approved study documents which include approved poster with graphics, approved poster text 
(without graphics if dissemination avenue does not allow graphics—i.e. with a list serv), 
approved bullet-pointed list of study highlights, approved dear colleagues text.  
 
Subject Enrollment 
Methods of Enrollment: Interested participants will be instructed to call or email study staff who 
will give the patients a brief overview of the study, then perform a telephone or an online pre-
screening.  
Procedures for obtaining informed consent: Consent will initially be discussed with participants 
over the phone. On their initial pre-treatment visit, written consent will be obtained with either a 
study physician or psychologist.   
 
Treatment assignment and randomization, if applicable: Patients meeting study criteria will be 
randomized into one of two groups, either the NF-MM or MM group on a rolling admission. 
Preliminary assessment after 10 subjects enrolled in the study, demonstrated that participants in 
the intervention (MUSE) group had higher rates of depressive symptoms than participants in the 
control group. In order to balance these groups, we subsequently have decided to stratify by 
depression scores, such that the next five enrolled participants would be placed in the MUSE 
group if they had lower than average (for the study) BDI scores or the control group if they had 
higher than average (for the study) BDI scores. After these five subjects were enrolled, we will 
recalculate average BDI scores and decide whether to continue to stratify by depression scores 
or not.  
 
Additionally, we have decided to add a no-treatment control group of 10 subjects. These 
individuals will be recruited after the first 20 subjects complete the trial. Thus, 30 subjects in 
total will now be part of this study.  
 
Study Procedures 
Study Site: Pre- and post-treatment assessments will be performed in outpatient offices at SRH 
in Charlestown or Cambridge (for those enrolled in the SRH study). MUSE training session will 
occur during the pre-treatment assessment session for the intervention groups. This training will 
last approximately 30 minutes and include a MM session with or without auditory NF. 
Participants will then perform their 6 weeks of NF-MM with MUSE or MM without MUSE at their 
homes. Study staff will also call participants on a weekly basis, to remind patients to practice 
and provide technical support. A post-treatment assessment session will take place within one 
week of completion of the intervention. Those in the no-treatment control group, will simply 
undergo pre- and post-neuropsychological testing 6 weeks apart and receive meditation and 
MUSE training at their final 6-week visit.  
 
Device to be used: MUSE hardware and Calm app software. MUSE is a consumer product, a 
“brain-sensing headband” lined with 7 frontotemporal EEG sensors that detect alpha, beta, 
delta, gamma, and theta waves. MUSE training begins with a calibration task whereby 
participants’ EEG waves are compared between an attentional and relaxation task. The Calm 
app guides participants through a mindfulness meditation exercise, providing instructions for 
users to close their eyes, relax their body, and pay careful attention to their breath. During this 
meditative practice, EEG signals are fed back to patients through auditory feedback, a calm 

versus noisy wind. When participants are consistently in a relaxed state, they will hear birds 
chirping. Through this auditory feedback, patients are trained to maximize their relaxed, 
attentive states, and minimize their distracted, tense states. User’s performance and progress is 
tracked over time on a mobile device. MM controls will use a custom version of the Calm 
software for directed meditation without the MUSE EEG NF component. For further details 
regarding details of the MUSE device, please see attached documents.  
 
Data to be collected:  
1) Outcome measurements: 
a. Cognitive assessments: Trail-Making Test (from D-KEFS), Symbol-Digit Coding, WAIS-
IV Digit Span (forward, backward, sequencing), the Connor’s Continuous Performance 
Test 3rd version (CPT-3), and the Self Efficacy (SEsx) scale.  
b. Affective assessments: 1) Beck Anxiety Inventory (BAI), 2) Beck Depression Inventory 
(BDI-II), 3) Neurobehavioral Symptom Inventory (NSI) 
c. Mindfulness assessment: Cognitive and Affective Mindfulness Scale – Revised (CAMS-
R) 
2) Compliance to intervention: The Calm app will track daily meditation practice adherence in 
both the NF-MM and the MM groups.  
3) EEG data for NF-MM or MM groups: The Calm app will track the percentage of time 
participants in the NF-MM group spend in a relaxed attentive state during training. 
Additionally at the end of the 6-week intervention, both NF-MM and MM groups will be 
asked to meditate while connected to EEG leads without auditory neurofeedback. The 
percentage of time spent in a calm, neural, and active state will be assessed here as well.  
4) Qualitative assessment: Both NF-MM and MM groups will undergo a very brief qualitative 
interview at their post-treatment session to inquire on their subjective experience with MM 
with or without NF. The MM will then receive a MUSE device and practice NF-MM for two 
additional weeks, after which point they will receive a phone call with further questioning 
regarding their experience with MM with or without NF.  
 
Biostatistical Analysis 
First, we will power this study using the effect size that we calculate from the cognitive MUSE 
data collected by Bhayee et al. Then, we will compare our NF-MM, MM, and no-treatment 
control groups.  We will contrast the three groups’ cognitive outcomes in trail-making, symbol-
digit coding, WAIS-IV digit spans.  We will then compare affective outcomes using the Beck 
Anxiety Inventory, Beck Depression Inventory and Neurobehavioral Symptom Inventory.  Finally 
we will compare mindfulness data from the Cognitive and Affective Mindfulness Scale.  The 
continuous variables from the cognitive and affective measures will be analyzed with linear 
regression.  The statistical contribution of demographic variables will be assessed using mixed 
effects models.  We plan to perform post-hoc analysis for multiple comparisons.   
 
Risks and Discomforts 
Complications of procedures: We do not anticipate significant adverse effects from the use of 
MUSE technology, as it is already in wide use in the general population without reports of any 
significant harm. However, other neurofeedback studies have documented patient complaints of 
fatigue, feeling “spacey,” anxiety, irritability, headache, or difficulty falling asleep (Hammond et 
al. 2011). Subjects will be able to contact study staff during daytime hours with questions or 
concerns regarding the possibility of such adverse effects. If these symptoms are believed to be 
stemming directly from use of MUSE and are intolerable for patients, they will be instructed to 
discontinue participation in the study.  
 
Device complications/malfunctions: While it is not expected, it is possible for the MUSE device 
to malfunction. Participants will be able to email or call with tech support questions during 
standard business hours. Study staff members will call patients back to troubleshoot. While 

equipment malfunction could interfere with data collection, it will not put patients at any risk of 
harm.  
 
Psychological non medical risk: Meditation practice has very infrequent adverse effects. 
However in patients with severe mental illness (severe depression, suicidality, disabling anxiety, 
tendency toward dissociation), spending time silent, alone with one’s thought in a repetitive 
practice can rarely exacerbate psychopathology. These patients will be carefully screened and 
excluded from participating in the study. If MM is stirring up unpleasant thoughts and feelings, 
they will be able to reach study staff members during business hours, and if necessary will be 
discontinued from the study. Participants in this study will also be asked to fill out the BDI-II form 
during pre- and post-test visits. A contingency plan is in place if participants exhibit suicidal 
ideation. Please see the attached document.   
 
Disclosure of Confidential Information: All patient information will be kept confidential in this 
study and will not be shared outside of study collaborators. Subjects’ data that is collected via 
MUSE will also be safeguarded. Please see the attached data handling form from MUSE. 
Importantly, subjects data that is stored on MUSE does not include personal health information. 
It includes the participant’s username, email, frequency of MM training, and EEG waves during 
meditation. Users’ accounts are also password protected.  
 
Minimization of Risks: Risks of loss of privacy will remain as with any study. For this reason, all 
data collected from participants will be kept in a secure, password protected database. 
Trackable correspondence with participants, ie email, will be conducted through a secure 
exchanger. Participants’ data will be de-identified at the onset of the study and assigned a 
subject number that will be used to keep track of their study data. A key linking patient’s names 
and their study number will only be available to key research personnel.  All study data will be 
stored in a secure location, maintained either electronically on a password protected computer 
or if on paper, in a locked cabinet in a private office or office requiring a security badge to enter. 
Printed computer data that is no longer needed for research purposes will be properly disposed 
of in secure, confidential medical paperwork waste bins.  
 
 
Potential Benefits 
Potential benefits to participants: Based on the mindfulness meditation literature, participation in 
the NF-MM or MM arms of this study is likely to have a positive impact on a patient’s mood, 
anxiety, and biological stress levels. It may also help with attentional impairment. Individuals in 
the no-treatment control group will continue with care as usual. They are not expected to benefit 
directly from participation in this study.  
 
All participants in all groups will receive a Muse device in compensation for completing the 
study.  
 
Potential benefits to society (e.g., increased understanding of disease processes): Information 
from this study could potentially be useful to mTBI patients on a population level. If NF-MM is 
shown to significantly outperform standard MM in terms of psychological and cognitive 
performance, mTBI patients and their clinicians may want to consider using MUSE following 
brain injury. If NF does not enhance participants’ practice of MM, mTBI patients and their 
clinicians will want to recommend against the use of the device, as its cost does not bear out in 
improved outcomes. If the NF-MM or MM groups outperform the no-treatment control group, 
results will suggest that various types of meditation interventions may be useful for affective or 
cognitive symptoms in individuals with traumatic brain injury.  
 

Monitoring and QA 
Independent monitoring of source data: Study staff, physicians or psychologists, will be 
responsible for reviewing the accuracy and completeness of form entries, case documents, and 
informed consent.  
 
Safety and outcomes monitoring: Safety and efficacy data will be reviewed on a weekly basis 
through email or phone correspondence between participants and either a physician or 
psychologist study staff member. If the practice of meditation or use of neurofeedback is 
causing significant psychological distress or physical discomfort, the patient will be advised to 
discontinue participation.  
 
Adverse event reporting guidelines: All reports of adverse psychological and physical effects will 
be relayed directly to the study PI and to MUSE.  
 
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Study Schematic: see attached  
 
Appendices 
FDA approved drug: Not applicable; see attached user’s manual for MUSE device  
 
Schematic of Device (for device studies): please see user’s manual for MUSE device   
 
Patient/Ss recruitment material (advertisements, Dear Colleague letters, flyers, etc.): see 
attached  
 
Survey tools if applicable: see attached