Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents

Depression Clinical Trial

Official title:

Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06183580
• Other study ID #: CR00497392
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2, 2022
• Est. completion date: November 5, 2023

Study information

• Verified date: December 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A non invasive treatment study including participants at risk for suicide attempts and undergoing neurofeedback training. Neurofeedback is controlling your brain activity in real time inside the scanner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 5, 2023
• Est. primary completion date: November 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• Adolescents with a history of suicide attempts

Exclusion Criteria:

• Psychotic disorders.
• Primary substance use disorder.
• Primary anorexic disorder.
• Autism Spectrum Disorder.

Related Conditions & MeSH terms

• Depression
• Suicide
• Suicide, Attempted
• Suicide, Ideation

Intervention

Other:
• neurofeedback training involving dACC
Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four ~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity > baseline and red = Activity < baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
• neurofeedback training involving amygdala
Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four ~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity > baseline and red = Activity < baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	suicide ideation	suicide ideation questionnaire	1 week and 1 month following intervention