NCT03929263

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2021

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

September 24, 2024

Completed
Last Updated

September 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1.4 years

First QC Date

April 22, 2019

Results QC Date

November 20, 2023

Last Update Submit

June 4, 2024

Conditions

Testing Protocol With Healthy Individuals for Feasibility

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    Baseline (Acquired during scan session)

Study Arms (1)

Real-time fMRI neurofeedback

EXPERIMENTAL

All participants will receive neurofeedback from the target region (no sham condition).

Behavioral: Real-time fMRI neurofeedback

Interventions

Real-time fMRI neurofeedbackBEHAVIORAL

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

Real-time fMRI neurofeedback

Eligibility Criteria

Age13 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (1)

  • 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.

    PMID: 35721350DERIVED

Limitations and Caveats

This is a feasibility study with a small sample and no control group.

Results Point of Contact

Title
Kara Kerr
Organization
Oklahoma State University
kara.kerr@okstate.edu
9186971478

Study Officials

  • Kara L Kerr, PhD

    Oklahoma State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 26, 2019

Study Start

September 25, 2019

Primary Completion

February 27, 2021

Study Completion

February 27, 2021

Last Updated

September 24, 2024

Results First Posted

September 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)