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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.
 
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:
Collaborator:
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 : 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

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

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 ]
    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.



Information from the National Library of Medicine

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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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02615535


Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital Boston
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
InteraXon, Inc.
Investigators
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Principal Investigator: Mel B Glenn, MD Spaulding Rehabilitation Hospital
  Study Documents (Full-Text)

Documents provided by Mel B. Glenn, Spaulding Rehabilitation Hospital:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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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