Traumatic Brain InjuryNCT02615535
Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury
A study testing EEG neurofeedback-assisted meditation and Non-EEG feedback-assisted meditation in people with Traumatic Brain Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- EEG neurofeedback-assisted meditation and Non-EEG feedback-assisted meditation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of mild-moderate traumatic brain injury
- impaired attention or concentration
- >1 year since traumatic brain injury
- ability to participate in neurofeedback and mindfulness meditation
- daily access to a smart phone
- on stable dosage of neuropsychological medications with no significant changes planned for the duration of the study
- no prior history of a meditation practice
Who cannot join
- severe mental illness or psychological symptoms (severe depression, suicidality, disabling anxiety, PTSD, psychosis, dissociation)
- significant pre-morbid learning disability
- current or recent (in past year) history of significant drug or alcohol abuse
- medical illness severe enough to result in an attentional disorder
- neurodegenerative disease
- non-fluency in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital Boston
Charlestown, Massachusetts, 02129
About this study
Official title: Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- EEG neurofeedback-assisted meditation, Non-EEG feedback-assisted meditation
- Keywords
- traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG neurofeedback-assisted meditationDevice
Also called MUSE
meditation with auditory feedback regarding EEG status
Non-EEG feedback-assisted meditationDevice
Also called MUSE without EEG feedback
meditation without auditory feedback regarding EEG status
| Study group | Role | What they receive |
|---|---|---|
| EEG neurofeedback-assisted meditation | Experimental | EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. Receives: Device: EEG neurofeedback-assisted meditation |
| Non-EEG feedback-assisted meditation | Active comparator | Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Receives: Device: Non-EEG feedback-assisted meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neurobehavioral Symptom Inventory
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.
Measured: baseline and six weeks
Secondary outcomes (7)
Change in Wechsler Adult Intelligence Scale-IV Digit Span
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.
Measured: baseline and six weeks
Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding
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.
Measured: baseline and six weeks
Change in Trail Making Test
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.
Measured: baseline and six weeks
Change in Beck Anxiety Inventory
Subjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome.
Measured: baseline and six weeks
Change in Beck Depression Inventory-II
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.
Measured: baseline and six weeks
Change in Cognitive and Affective Mindfulness Scale-Revised
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.
Measured: baseline and six weeks
Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device
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.
Measured: baseline and at six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- InteraXon, Inc.
- Responsible party
- Principal investigator, Mel B. Glenn, Spaulding Rehabilitation Hospital
- Investigators
- Mel B Glenn, MD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615535
- Sponsor's protocol ID
- 2015P002184
- Status last verified
- Mar 2020
- First submitted
- 18 Nov 2015
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: If participants request their outcome data, we will provide this to them with a brief discussion of its meaning and limitations on interpretation.
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.
PubMed 24109463Chiesa 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.
PubMed 21183265Cicerone 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.
PubMed 21440699Hofmann 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.
PubMed 20350028Polich 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.
PubMed 32783645
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02615535
- Acronym / sponsor ID
- 2015P002184
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- InteraXon, Inc.
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Posted 6 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG neurofeedback-assisted meditation | Experimental | Device: EEG neurofeedback-assisted meditationEEG neurofeedback assisted meditation using the MUSE device and auditory feedback. |
| Non-EEG feedback-assisted meditation | Active comparator | Device: Non-EEG feedback-assisted meditationNon-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- history of mild-moderate traumatic brain injury
- impaired attention or concentration
- >1 year since traumatic brain injury
- ability to participate in neurofeedback and mindfulness meditation
- daily access to a smart phone
Key exclusion criteria (6 listed)
- severe mental illness or psychological symptoms (severe depression, suicidality, disabling anxiety, PTSD, psychosis, dissociation)
- significant pre-morbid learning disability
- current or recent (in past year) history of significant drug or alcohol abuse
- medical illness severe enough to result in an attentional disorder
- neurodegenerative disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG neurofeedback-assisted meditationAlso: MUSEmeditation with auditory feedback regarding EEG status | Device | EEG neurofeedback-assisted meditation |
| Non-EEG feedback-assisted meditationAlso: MUSE without EEG feedbackmeditation without auditory feedback regarding EEG status | Device | Non-EEG feedback-assisted meditation |
Primary outcome
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.
7 secondary outcomes
Change in Wechsler Adult Intelligence Scale-IV Digit Span
Time frame: baseline and six weeks
Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding
Time frame: baseline and six weeks
Change in Trail Making Test
Time frame: baseline and six weeks
Change in Beck Anxiety Inventory
Time frame: baseline and six weeks
Change in Beck Depression Inventory-II
Time frame: baseline and six weeks
Change in Cognitive and Affective Mindfulness Scale-Revised
Time frame: baseline and six weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24109463Brandmeyer T, Delorme A. Meditation and neurofeedback. Front Psychol. 2013 Oct 7;4:688. doi: 10.3389/fpsyg.2013.00688. eCollection 2013. No abstract available.
- Background: PubMed 21183265Chiesa 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.
- Background: PubMed 21440699Cicerone 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.
- Background: PubMed 20350028Hofmann 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.
- Derived from this study: PubMed 32783645Polich 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.
- Individual participant dataSharing planned: Yes. If participants request their outcome data, we will provide this to them with a brief discussion of its meaning and limitations on interpretation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mel B Glenn, MD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG neurofeedback-assisted meditation and Non-EEG feedback-assisted meditation in people with Traumatic Brain Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neurobehavioral Symptom Inventory (time frame: baseline and six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02615535, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.