Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

NCT02615535 | Completed Results

• 1 other identifier: 2015P002184
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and six weeks

Secondary Outcomes (7)

• Change in Wechsler Adult Intelligence Scale-IV Digit Span

  baseline and six weeks

• Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding

  baseline and six weeks

• Change in Trail Making Test

  baseline and six weeks

• Change in Beck Anxiety Inventory

  baseline and six weeks

• Change in Beck Depression Inventory-II

  baseline and six weeks

Study Arms (2)

EEG neurofeedback-assisted meditation

EXPERIMENTAL

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

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.

Device: Non-EEG feedback-assisted meditation

Interventions

EEG neurofeedback-assisted meditation DEVICE

meditation with auditory feedback regarding EEG status

Also known as: MUSE

EEG neurofeedback-assisted meditation

Non-EEG feedback-assisted meditation DEVICE

meditation without auditory feedback regarding EEG status

Also known as: MUSE without EEG feedback

Non-EEG feedback-assisted meditation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• InteraXon, Inc.: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital Boston

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (5)

• 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.

  PMID: 24109463 BACKGROUND

• 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.

  PMID: 21183265 BACKGROUND

• 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.

  PMID: 21440699 BACKGROUND

• 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.

  PMID: 20350028 BACKGROUND

• 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.

  PMID: 32783645 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Results Point of Contact

• Title: Dr. Ginger Polich
• Organization: Spaulding Rehabilitation Hospital

ginger.polich@mgh.harvard.edu

617 952 5000

Study Officials

• Mel B Glenn, MD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Outpatient and Community Brain Injury Rehabilitation

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 26, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: March 30, 2020
• Results First Posted: December 6, 2019

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)