Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

NCT ID: NCT02615535

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-12-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EEG neurofeedback-assisted meditation

EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.

Group Type: EXPERIMENTAL

EEG neurofeedback-assisted meditation

Intervention Type: DEVICE

meditation with auditory feedback regarding EEG status

Non-EEG feedback-assisted meditation

Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.

Group Type: ACTIVE_COMPARATOR

Non-EEG feedback-assisted meditation

Intervention Type: DEVICE

meditation without auditory feedback regarding EEG status

Interventions

EEG neurofeedback-assisted meditation

meditation with auditory feedback regarding EEG status

Intervention Type: DEVICE

Non-EEG feedback-assisted meditation

meditation without auditory feedback regarding EEG status

Intervention Type: DEVICE

Other Intervention Names

MUSE; MUSE without EEG feedback

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InteraXon, Inc.

INDUSTRY

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mel B. Glenn

Director of Outpatient and Community Brain Injury Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mel B Glenn, MD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital Boston

Charlestown, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24109463 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21183265 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21440699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20350028 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32783645 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015P002184

Identifier Type: -

Identifier Source: org_study_id