Trial Outcomes & Findings for Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury (NCT NCT02615535)
NCT ID: NCT02615535
Last Updated: 2020-03-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
baseline and six weeks
Results posted on
2020-03-30
Participant Flow
Participant milestones
| Measure |
EEG Neurofeedback-assisted Meditation
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: 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.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
EEG Neurofeedback-assisted Meditation
n=10 Participants
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status
|
Non-EEG Feedback-assisted Meditation
n=10 Participants
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and six weeksMeasures 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.
Outcome measures
| Measure |
EEG Neurofeedback-assisted Meditation
n=10 Participants
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status
|
Non-EEG Feedback-assisted Meditation
n=10 Participants
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
|---|---|---|
|
Change in Neurobehavioral Symptom Inventory
baseline
|
35.2 units on a scale
Standard Error 3
|
33.1 units on a scale
Standard Error 5.1
|
|
Change in Neurobehavioral Symptom Inventory
6 weeks
|
27.7 units on a scale
Standard Error 2.8
|
24.6 units on a scale
Standard Error 3.9
|
SECONDARY outcome
Timeframe: baseline and six weeksTests participants digit span, repeating forward sequences of digits from 2 to 8. Scale ranges from 0 to 16. Higher scores mean a better outcome.
Outcome measures
| Measure |
EEG Neurofeedback-assisted Meditation
n=10 Participants
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status
|
Non-EEG Feedback-assisted Meditation
n=10 Participants
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
|---|---|---|
|
Change in Wechsler Adult Intelligence Scale-IV Digit Span
baseline
|
10.4 units on a scale
Standard Error 0.7
|
11.2 units on a scale
Standard Error 1
|
|
Change in Wechsler Adult Intelligence Scale-IV Digit Span
six weeks
|
10.9 units on a scale
Standard Error 0.6
|
11.8 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: baseline and six weeksA 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.
Outcome measures
| Measure |
EEG Neurofeedback-assisted Meditation
n=10 Participants
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status
|
Non-EEG Feedback-assisted Meditation
n=10 Participants
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
|---|---|---|
|
Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding
baseline
|
11.6 units on a scale
Standard Error 1.2
|
11.1 units on a scale
Standard Error 0.9
|
|
Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding
six weeks
|
13.1 units on a scale
Standard Error 1.1
|
12.5 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: baseline and six weeksSubjects 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.
Outcome measures
| Measure |
EEG Neurofeedback-assisted Meditation
n=10 Participants
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status
|
Non-EEG Feedback-assisted Meditation
n=10 Participants
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
|---|---|---|
|
Change in Trail Making Test
baseline
|
10.9 units on a scale
Standard Error 1
|
11.9 units on a scale
Standard Error 0.4
|
|
Change in Trail Making Test
six weeks
|
12.3 units on a scale
Standard Error 0.8
|
12.7 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: baseline and six weeksSubjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome.
Outcome measures
| Measure |
EEG Neurofeedback-assisted Meditation
n=10 Participants
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status
|
Non-EEG Feedback-assisted Meditation
n=10 Participants
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
|---|---|---|
|
Change in Beck Anxiety Inventory
baseline
|
15.9 score on a scale
Standard Error 1.9
|
18.8 score on a scale
Standard Error 4.6
|
|
Change in Beck Anxiety Inventory
six weeks
|
11.5 score on a scale
Standard Error 1.9
|
8.5 score on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: baseline and six weeksSubjects 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.
Outcome measures
| Measure |
EEG Neurofeedback-assisted Meditation
n=10 Participants
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status
|
Non-EEG Feedback-assisted Meditation
n=10 Participants
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
|---|---|---|
|
Change in Beck Depression Inventory-II
baseline
|
19.9 score on a scale
Standard Error 3.6
|
17 score on a scale
Standard Error 3.5
|
|
Change in Beck Depression Inventory-II
six weeks
|
13.1 score on a scale
Standard Error 3.1
|
9.9 score on a scale
Standard Error 2.8
|
SECONDARY outcome
Timeframe: baseline and six weeksSubjects 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.
Outcome measures
| Measure |
EEG Neurofeedback-assisted Meditation
n=10 Participants
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status
|
Non-EEG Feedback-assisted Meditation
n=10 Participants
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
|---|---|---|
|
Change in Cognitive and Affective Mindfulness Scale-Revised
baseline
|
24.2 score on a scale
Standard Error 2
|
24.7 score on a scale
Standard Error 1.8
|
|
Change in Cognitive and Affective Mindfulness Scale-Revised
six weeks
|
27.3 score on a scale
Standard Error 1.6
|
28.3 score on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: baseline and at six weeksChange 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.
Outcome measures
| Measure |
EEG Neurofeedback-assisted Meditation
n=10 Participants
EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.
EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status
|
Non-EEG Feedback-assisted Meditation
n=10 Participants
Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.
Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
|
|---|---|---|
|
Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device
baseline
|
49.7 percentage of "Calm"
Standard Error 5.6
|
32 percentage of "Calm"
Standard Error 7.8
|
|
Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device
six weeks
|
57.7 percentage of "Calm"
Standard Error 7.6
|
43.7 percentage of "Calm"
Standard Error 9.9
|
Adverse Events
EEG Neurofeedback-assisted Meditation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-EEG Feedback-assisted Meditation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place