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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Suicide, Attempted; Suicide, Ideation
• Intervention / Treatment: Other: neurofeedback training involving dACC; Other: neurofeedback training involving amygdala

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adolescents with a history of suicide attempts

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dACC Arm; Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex	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.
Experimental: rAMY Arm; Participants assigned to the Neurofeedback from the amygdala	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
suicide ideation	suicide ideation questionnaire	1 week and 1 month following intervention

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Karina Quevedo, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): November 5, 2023
• Study Completion (Actual): November 5, 2023

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: CR00497392

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No