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Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02615535
Recruitment Status : Active, not recruiting
First Posted : November 26, 2015
Last Update Posted : September 13, 2017
InteraXon, Inc.
Information provided by (Responsible Party):
Mel B. Glenn, Spaulding Rehabilitation Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. change in Neurobehavioral Symptom Inventory [ Time Frame: baseline and six weeks ]

Secondary Outcome Measures :
  1. change in Wechsler Adult Intelligence Scale-IV Digit Span [ Time Frame: baseline and six weeks ]
  2. change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding [ Time Frame: baseline and six weeks ]
  3. change in Trail Making Test [ Time Frame: baseline and six weeks ]
  4. change in Beck Anxiety Inventory [ Time Frame: baseline and six weeks ]
  5. change in Beck Depression Inventory-II [ Time Frame: baseline and six weeks ]
  6. change in Cognitive and Affective Mindfulness Scale-Revised [ Time Frame: baseline and six weeks ]
  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, throughout intervention, and at six weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02615535

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United States, Massachusetts
Spaulding Rehabilitation Hospital Boston
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
InteraXon, Inc.
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Principal Investigator: Mel B Glenn, MD Spaulding Rehabilitation Hospital

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Responsible Party: Mel B. Glenn, Director of Outpatient and Community Brain Injury Rehabilitation, Spaulding Rehabilitation Hospital Identifier: NCT02615535     History of Changes
Other Study ID Numbers: 2015P002184
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
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:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System