N/A
N=25
Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02615535 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Change in Neurobehavioral Symptom Inventory — 35.2; 33.1; 27.7; 24.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EEG neurofeedback-assisted meditation (Device); Non-EEG feedback-assisted meditation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Neurobehavioral Symptom Inventory |
35.2; 33.1; 27.7; 24.6 | — |
| SECONDARY Change in Wechsler Adult Intelligence Scale-IV Digit Span |
10.4; 11.2; 10.9; 11.8 | — |
| SECONDARY Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding |
11.6; 11.1; 13.1; 12.5 | — |
| SECONDARY Change in Trail Making Test |
10.9; 11.9; 12.3; 12.7 | — |
| SECONDARY Change in Beck Anxiety Inventory |
15.9; 18.8; 11.5; 8.5 | — |
| SECONDARY Change in Beck Depression Inventory-II |
19.9; 17; 13.1; 9.9 | — |
| SECONDARY Change in Cognitive and Affective Mindfulness Scale-Revised |
24.2; 24.7; 27.3; 28.3 | — |
| SECONDARY Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device |
49.7; 32; 57.7; 43.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02615535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.