Trial Outcomes & Findings for Parent-Adolescent Training on Neurofeedback and Synchrony (NCT NCT03929263)

Last Updated: 2024-09-24

Results Overview

Rating scale of perceived effectiveness in completing the task and changing brain activation. Likert scale ranging from 0-10, with higher numbers indicating greater perceived effectiveness.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

Baseline (Acquired during scan session)

Results posted on

2024-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Real-time fMRI Neurofeedback All participants will receive neurofeedback from the target region (no sham condition). Real-time fMRI neurofeedback: Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Parent-Adolescent Training on Neurofeedback and Synchrony

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Real-time fMRI Neurofeedback n=24 Participants All participants will receive neurofeedback from the target region (no sham condition). Real-time fMRI neurofeedback: Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Acquired during scan session)

Population: Parents who participated in at least one neurofeedback session with available data for this outcome variable

Rating scale of perceived effectiveness in completing the task and changing brain activation. Likert scale ranging from 0-10, with higher numbers indicating greater perceived effectiveness.

Outcome measures

Outcome measures
Measure	Real-time fMRI Neurofeedback n=11 Participants All participants will receive neurofeedback from the target region (no sham condition). Real-time fMRI neurofeedback: Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
Neurofeedback Rating Scale	5.7 units on a scale Standard Deviation 2.14

PRIMARY outcome

Timeframe: Baseline (Acquired during scan session)

Population: Only data from participants used in the neuroimaging results were analyzed.

Rating scale asking about current experience of various emotions (happy, sad, angry, etc.). Scale ranges from 0-10, with higher numbers indicating more intense emotions.

Outcome measures

Outcome measures
Measure	Real-time fMRI Neurofeedback n=6 Participants All participants will receive neurofeedback from the target region (no sham condition). Real-time fMRI neurofeedback: Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
Emotion Rating Scale	2.11 units on a scale Standard Deviation 1.46

PRIMARY outcome

Timeframe: Baseline (Acquired during scan session)

Population: Only adolescents' data that passed quality control were analyzed. Values are taken from the anterior insula and averaged across scanning runs and participants.

Activation in the brain region targeted for neurofeedback and associated regions; resting-state network activity

Outcome measures

Outcome measures
Measure	Real-time fMRI Neurofeedback n=6 Participants All participants will receive neurofeedback from the target region (no sham condition). Real-time fMRI neurofeedback: Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation)	0.15 percent signal change Standard Deviation 0.38

Adverse Events

Real-time fMRI Neurofeedback

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

Kara Kerr

Oklahoma State University

Phone: 9186971478

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place