Trial Outcomes & Findings for Treating Phobia With Multivoxel Neuro-reinforcement (NCT NCT03655262)
NCT ID: NCT03655262
Last Updated: 2024-02-02
Results Overview
The neural measure of difference in amygdala reactivity (measured by fMRI) to target phobic animals compared to control phobic animals from pre-treatment to post-treatment. Lower numbers (i.e. more negative numbers) indicate greater amygdala decrease and and better outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
10 days (measured at pre-treatment and post-treatment)
Results posted on
2024-02-02
Participant Flow
Participant milestones
| Measure |
1 Session
1 neuro-reinforcement session
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete x day(s) of neuro-reinforcement.
|
3 Sessions
3 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete x day(s) of neuro-reinforcement.
|
5 Sessions
5 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete x day(s) of neuro-reinforcement.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
1 Session
1 neuro-reinforcement session
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete x day(s) of neuro-reinforcement.
|
3 Sessions
3 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete x day(s) of neuro-reinforcement.
|
5 Sessions
5 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete x day(s) of neuro-reinforcement.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Treating Phobia With Multivoxel Neuro-reinforcement
Baseline characteristics by cohort
| Measure |
1 Session
n=7 Participants
1 neuro-reinforcement session
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 1 day(s) of neuro-reinforcement.
|
3 Sessions
n=8 Participants
3 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 3 day(s) of neuro-reinforcement.
|
5 Sessions
n=8 Participants
5 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 5 day(s) of neuro-reinforcement.
|
Total
n=23 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
26 Years
STANDARD_DEVIATION 6.78 • n=5 Participants
|
24.14 Years
STANDARD_DEVIATION 14.24 • n=7 Participants
|
25.86 Years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
25.3 Years
STANDARD_DEVIATION 9.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 days (measured at pre-treatment and post-treatment)The neural measure of difference in amygdala reactivity (measured by fMRI) to target phobic animals compared to control phobic animals from pre-treatment to post-treatment. Lower numbers (i.e. more negative numbers) indicate greater amygdala decrease and and better outcomes.
Outcome measures
| Measure |
1 Session
n=7 Participants
1 neuro-reinforcement session
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 1 day(s) of neuro-reinforcement.
|
3 Sessions
n=8 Participants
3 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 3 day(s) of neuro-reinforcement.
|
5 Sessions
n=8 Participants
5 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 5 day(s) of neuro-reinforcement.
|
|---|---|---|---|
|
Change in Amygdala Reactivity
|
-.691 Beta Coefficient
Standard Deviation .796
|
-.827 Beta Coefficient
Standard Deviation 1.620
|
-.278 Beta Coefficient
Standard Deviation 1.682
|
PRIMARY outcome
Timeframe: 10 days (measured at pre-treatment and post-treatment)Subjective Fear Ratings of images of targeted phobic stimuli Minimum score of 0, Maximum score of 180, higher scores mean worse outcome.
Outcome measures
| Measure |
1 Session
n=5 Participants
1 neuro-reinforcement session
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 1 day(s) of neuro-reinforcement.
|
3 Sessions
n=6 Participants
3 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 3 day(s) of neuro-reinforcement.
|
5 Sessions
n=6 Participants
5 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 5 day(s) of neuro-reinforcement.
|
|---|---|---|---|
|
Subjective Fear Post-treatment Minus Pre-treatment
|
0.32 units on a scale
Standard Deviation 0.32
|
-0.03 units on a scale
Standard Deviation 0.37
|
0.43 units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 10 days (measured at pre-treatment and post-treatment)Skin conductance to image presentation of targeted phobic stimuli post-treatment minus pre-treatment
Outcome measures
| Measure |
1 Session
n=1 Participants
1 neuro-reinforcement session
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 1 day(s) of neuro-reinforcement.
|
3 Sessions
n=2 Participants
3 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 3 day(s) of neuro-reinforcement.
|
5 Sessions
n=4 Participants
5 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 5 day(s) of neuro-reinforcement.
|
|---|---|---|---|
|
Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment
|
-0.010 Square Rooted Microsiemens
Standard Deviation 0
|
-0.097 Square Rooted Microsiemens
Standard Deviation 0.181
|
-0.030 Square Rooted Microsiemens
Standard Deviation 0.192
|
SECONDARY outcome
Timeframe: 10 days (measured at pre-treatment and post-treatment)Subjective fear ratings of a list of typical phobic stimuli Minimum score of 40, maximum of 200, higher scores mean worse outcome.
Outcome measures
| Measure |
1 Session
n=7 Participants
1 neuro-reinforcement session
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 1 day(s) of neuro-reinforcement.
|
3 Sessions
n=8 Participants
3 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 3 day(s) of neuro-reinforcement.
|
5 Sessions
n=8 Participants
5 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 5 day(s) of neuro-reinforcement.
|
|---|---|---|---|
|
Fear Survey Schedule
|
-2.46 units on a scale
Standard Deviation 1.13
|
-5.00 units on a scale
Standard Deviation 1.12
|
-11.93 units on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 10 days (measured at pre-treatment and post-treatment)Measure of preferential allocation of attentional resources measured in reaction time (seconds) for visual presentation of the targeted phobic stimulus
Outcome measures
| Measure |
1 Session
n=6 Participants
1 neuro-reinforcement session
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 1 day(s) of neuro-reinforcement.
|
3 Sessions
n=5 Participants
3 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 3 day(s) of neuro-reinforcement.
|
5 Sessions
n=6 Participants
5 neuro-reinforcement sessions
Unconscious Neuro-reinforcement: Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 5 day(s) of neuro-reinforcement.
|
|---|---|---|---|
|
Stroop Task Post-treatment Minus Pre-treatment
|
-0.080 Seconds
Standard Deviation .079
|
-0.137 Seconds
Standard Deviation .198
|
-0.030 Seconds
Standard Deviation .203
|
Adverse Events
1 Session
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5 Sessions
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