NCT02615535

Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	EEG neurofeedback-assisted meditation	meditation with auditory feedback regarding EEG status
DEVICE	Non-EEG feedback-assisted meditation	meditation without auditory feedback regarding EEG status

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-01
• Completion: 2019-12-01
• First posted: 2015-11-26
• Last updated: 2020-03-30
• Results posted: 2019-12-06

Locations

1 site across 1 country: United States