Testing Protocol With Healthy Individuals for FeasibilityNCT03929263

Parent-Adolescent Training on Neurofeedback and Synchrony

A study testing Real-time fMRI neurofeedback in people with Testing Protocol With Healthy Individuals for Feasibility, run by Oklahoma State University Center for Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will test a real-time functional magnetic resonance imaging (fMRI) hyperscanning neurofeedback protocol for feasibility with ten mothers and their psychiatrically healthy adolescent daughters, with the eventual goal to test this in a sample of depressed adolescents in a future study. Read more about this study

Who is it for?: Ages 13 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Testing Protocol With Healthy Individuals for Feasibility
What is being tested?: Real-time fMRI neurofeedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 25 Sep 2019to 27 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 years and older
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Eligible for fMRI
Sufficient English fluency to complete tasks
BMI ≦ 40.0
Right-handed
Biological female
Co-residing at least 4 days/week

Show all 11Show fewer

Adult participants: Biological mother of adolescent participant
Adult participants:Primary caregiver > 50% of child's lifespan
Adult participants:BMI ≧ 18.0
Adolescent participants: Age 13-17 years
Adolescent participants: BMI ≧ 16.0

Who cannot join

Current psychiatric diagnosis
Medications influencing fMRI
Medical conditions influencing fMRI
Alcohol or psychoactive drug on scan day
Adolescent participants: Neurodevelopmental delay
Adolescent participants: History of mood or psychotic disorder
Adolescent participants: History of obsessive-compulsive disorder (OCD) or attention-deficit/hyperactivity disorder (ADHD)

Trial locations and contacts

1 site in 1 country.

United States1 site

Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136

Other trials in United States

About this study

Official title: The Dyadic Inter-Brain Signaling (DIBS) Project With Parent-Adolescent Training on Neurofeedback and Synchrony

Read the detailed description

This study will utilize a rigorous multi-method, multi-informant design to examine the effects of dyadic neurofeedback (dnf) on adolescent brain activation with fMRI hyperscanning. Parents and adolescents will also report on emotion regulation, depressive symptoms, and parenting practices. Data collection procedures will take place at the Laureate Institute for Brain Research (LIBR), which is equipped with two identical scanners that have advanced real-time fMRI systems capable of conducting parallel fMRI hyperscanning, including the capacity for neurofeedback. Parents will complete a phone screen to determine initial eligibility. If initial study criteria are met, a 2-hour in-person lab visit will be scheduled where mothers and daughters will complete consent/assent; diagnostic interviews; surveys on emotion regulation, parenting practices, depression, and anxiety; and additional screening. Survey data will be used for preliminary exploratory analyses. Based on data collected from the screening visit, participants will be invited to participate in the full study: a 4-hour visit where mothers and daughters will complete emotion ratings, mock scanner training, and fMRI tasks individually and together using hyperscanning (scan time = 16 min resting-state [2 runs], 7 min structural MRI, 40 min fMRI tasks, 10 min clinical MRI scans).

Conditions: Testing Protocol With Healthy Individuals for Feasibility
Being tested: Real-time fMRI neurofeedback

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Real-time fMRI neurofeedbackBehavioural
Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.

Study groups in NCT03929263
Study group	Role	What they receive
Real-time fMRI neurofeedback	Experimental	All participants will receive neurofeedback from the target region (no sham condition). Receives: Behavioral: Real-time fMRI neurofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Neurofeedback Rating Scale
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.
Measured: Baseline (Acquired during scan session)
Emotion Rating Scale
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.
Measured: Baseline (Acquired during scan session)
Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation)
Activation in the brain region targeted for neurofeedback and associated regions; resting-state network activity
Measured: Baseline (Acquired during scan session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 201927 Feb 2021

First posted26 Apr 2019
Study start25 Sep 2019
Primary completion27 Feb 2021
Study completion27 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Testing Protocol With Healthy Individuals for FeasibilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03929263
Sponsor's protocol ID: CHS2017011
Status last verified: Jun 2024
First submitted: 22 Apr 2019
Last updated: 24 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kerr KL, Ratliff EL, Cohen ZP, Fuller S, Cosgrove KT, DeVille DC, Misaki M, Morris AS, Bodurka J. Real-Time Functional Magnetic Resonance Imaging Dyadic Neurofeedback for Emotion Regulation: A Proof-of-Concept Study. Front Hum Neurosci. 2022 May 26;16:910951. doi: 10.3389/fnhum.2022.910951. eCollection 2022.
PubMed 35721350

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Dyadic Inter-Brain Signaling (DIBS) Project With Parent-Adolescent Training on Neurofeedback and Synchrony
ClinicalTrials.gov ID: NCT03929263
Acronym / sponsor ID: CHS2017011
Conditions: Testing Protocol With Healthy Individuals for Feasibility
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Oklahoma State University Center for Health SciencesUniversity, hospital or other
Collaborators: Oklahoma State University
Study start: 25 Sep 2019 (actual)
Primary completion: 27 Feb 2021 (actual)
Study completion: 27 Feb 2021 (actual)
First posted: 26 Apr 2019 (actual)
Results: Posted 24 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Real-time fMRI neurofeedback	Experimental	Behavioral: Real-time fMRI neurofeedbackAll participants will receive neurofeedback from the target region (no sham condition).

Who may qualify

Ages: 13 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Eligible for fMRI
Sufficient English fluency to complete tasks
BMI ≦ 40.0
Right-handed
Biological female

Key exclusion criteria (7 listed)

Current psychiatric diagnosis
Medications influencing fMRI
Medical conditions influencing fMRI
Alcohol or psychoactive drug on scan day
Adolescent participants: Neurodevelopmental delay

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Real-time fMRI neurofeedbackParticipants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.	Behavioural	Real-time fMRI neurofeedback

Primary outcome

Neurofeedback Rating Scale
Time frame: Baseline (Acquired during scan session)
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.
Emotion Rating Scale
Time frame: Baseline (Acquired during scan session)
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.
Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation)
Time frame: Baseline (Acquired during scan session)
Activation in the brain region targeted for neurofeedback and associated regions; resting-state network activity

Results and safety

Results posted to the registry on 24 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Real-time fMRI Neurofeedback	24	24

Primary outcome: Neurofeedback Rating Scale

Time frame: Baseline (Acquired during scan session). Mean (Standard Deviation). Unit: units on a scale

Measure	Real-time fMRI Neurofeedback n = 11
Value	5.7 (2.14)

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

Primary outcome: Emotion Rating Scale

Time frame: Baseline (Acquired during scan session). Mean (Standard Deviation). Unit: units on a scale

Measure	Real-time fMRI Neurofeedback n = 6
Value	2.11 (1.46)

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

Primary outcome: Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation)

Time frame: Baseline (Acquired during scan session). Mean (Standard Deviation). Unit: percent signal change

Measure	Real-time fMRI Neurofeedback n = 6
Value	0.15 (0.38)

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

Adverse events

Time frame: 3 months (Participants completed baseline measures over the course of approximately 1 month followed by 2 months of biweekly follow-ups.). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Real-time fMRI Neurofeedback	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Limitations and caveats (from the sponsor): This is a feasibility study with a small sample and no control group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35721350Kerr KL, Ratliff EL, Cohen ZP, Fuller S, Cosgrove KT, DeVille DC, Misaki M, Morris AS, Bodurka J. Real-Time Functional Magnetic Resonance Imaging Dyadic Neurofeedback for Emotion Regulation: A Proof-of-Concept Study. Front Hum Neurosci. 2022 May 26;16:910951. doi: 10.3389/fnhum.2022.910951. eCollection 2022.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kara L Kerr, PhD principal investigator

Oklahoma State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurofeedback Rating Scale (time frame: Baseline (Acquired during scan session)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03929263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.