Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

• ClinicalTrials.gov Identifier: NCT02615535
• Recruitment Status: Completed
• First Posted: November 26, 2015
• Results First Posted: December 6, 2019
• Last Update Posted: March 30, 2020
• Sponsor: Spaulding Rehabilitation Hospital
• Collaborator: InteraXon, Inc.
• Information provided by (Responsible Party): Mel B. Glenn, Spaulding Rehabilitation Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury	Device: EEG neurofeedback-assisted meditation; Device: Non-EEG feedback-assisted meditation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury
• Actual Study Start Date: December 2015
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: December 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: EEG neurofeedback-assisted meditation; EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.	Device: EEG neurofeedback-assisted meditation; meditation with auditory feedback regarding EEG status; Other Name: MUSE
Active Comparator: Non-EEG feedback-assisted meditation; Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.	Device: Non-EEG feedback-assisted meditation; meditation without auditory feedback regarding EEG status; Other Name: MUSE without EEG feedback

Outcome Measures

Primary Outcome Measures :

1. Change in Neurobehavioral Symptom Inventory [ Time Frame: 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 :

1. Change in Wechsler Adult Intelligence Scale-IV Digit Span [ Time Frame: 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.
2. Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding [ Time Frame: 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.
3. Change in Trail Making Test [ Time Frame: 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.
4. Change in Beck Anxiety Inventory [ Time Frame: 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.
5. Change in Beck Depression Inventory-II [ Time Frame: 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.
6. Change in Cognitive and Affective Mindfulness Scale-Revised [ Time Frame: 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.
7. Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Spaulding Rehabilitation Hospital Boston

Charlestown, Massachusetts, United States, 02129

Sponsors and Collaborators

Spaulding Rehabilitation Hospital

InteraXon, Inc.

Investigators

• Principal Investigator: Mel B Glenn, MD; Spaulding Rehabilitation Hospital

  Study Documents (Full-Text)

Documents provided by Mel B. Glenn, Spaulding Rehabilitation Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] November 1, 2016

More Information

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Mel B. Glenn, Director of Outpatient and Community Brain Injury Rehabilitation, Spaulding Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT02615535
• Other Study ID Numbers: 2015P002184
• First Posted: November 26, 2015
• Results First Posted: December 6, 2019
• Last Update Posted: March 30, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: If participants request their outcome data, we will provide this to them with a brief discussion of its meaning and limitations on interpretation.

Keywords provided by Mel B. Glenn, Spaulding Rehabilitation Hospital:

traumatic brain injury

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Alprostadil; Platelet Aggregation Inhibitors; Vasodilator Agents; Urological Agents