Clinical trial NCT02615535: Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury
Official title: Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: InteraXon, Inc.
First posted: 2015-11-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Neurobehavioral Symptom Inventory
timeFrame: baseline and six weeks
Secondary outcomes:
measure: Change in Wechsler Adult Intelligence Scale-IV Digit Span
timeFrame: baseline and six weeks
measure: Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding
timeFrame: baseline and six weeks
measure: Change in Trail Making Test
timeFrame: baseline and six weeks
measure: Change in Beck Anxiety Inventory
timeFrame: baseline and six weeks
measure: Change in Beck Depression Inventory-II
timeFrame: baseline and six weeks
measure: Change in Cognitive and Affective Mindfulness Scale-Revised
timeFrame: baseline and six weeks
measure: Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device
timeFrame: baseline and at six weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital Boston
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Mel B Glenn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandmeyer T, Delorme A. Meditation and neurofeedback. Front Psychol. 2013 Oct 7;4:688. doi: 10.3389/fpsyg.2013.00688. eCollection 2013. No abstract available.
citation: Chiesa A, Calati R, Serretti A. Does mindfulness training improve cognitive abilities? A systematic review of neuropsychological findings. Clin Psychol Rev. 2011 Apr;31(3):449-64. doi: 10.1016/j.cpr.2010.11.003. Epub 2010 Dec 1.
citation: Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
citation: Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.
citation: Polich G, Gray S, Tran D, Morales-Quezada L, Glenn M. Comparing focused attention meditation to meditation with mobile neurofeedback for persistent symptoms after mild-moderate traumatic brain injury: a pilot study. Brain Inj. 2020 Aug 23;34(10):1408-1415. doi: 10.1080/02699052.2020.1802781. Epub 2020 Aug 12.