NCT05545241

Brief Summary

The goal of this project is to help individuals better self-assess by taking advantage of their emotional feelings.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

September 8, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

September 8, 2022

Last Update Submit

September 29, 2022

Conditions

Risk-TakingEmotional Regulation

Keywords

risk-takingemotional neurofeedbackemotional regulation

Outcome Measures

Primary Outcomes (1)

  • Change in number of blue balloons adjusted with Balloon Analogue Risk Task [BART]

    Number of blue balloons adjusted with BART after 10 neurofeedback sessions among participants who received the neurofeedback treatment.

    Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)

Secondary Outcomes (4)

  • Change in EPs during BART

    Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)

  • Feasibility of controlling brain activity during neurofeedback sessions

    Baseline (Day 0), immediately after each neurofeedback sessions (session 1 to session 10) and at the study completion (after 10 neurofeedback sessions, Week 5)

  • Change in BIS-10 scores

    Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)

  • Change in MCQ scores

    Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)

Study Arms (2)

Neurofeedback and BART-EEG assessment

EXPERIMENTAL

Healthy subjects realized 10 sessions of emotional neurofeedback. Before (Baseline, Day 0), and after (at the study completion (after 10 neurofeedback sessions, Week 5)) neurofeedback sessions, the BART, assessing risk-taking behavior, coupled with an EEG record is realized by the subjects.

Behavioral: Neurofeedback + BART/EEG

BART-EEG assessment without neurofeedback

SHAM COMPARATOR

At the same times (Baseline, Day 0), and at the study completion (after 10 neurofeedback sessions, Week 5), healthy subjects realized the BART, assessing risk-taking behavior, coupled with an EEG record.

Behavioral: BART/EEG only

Interventions

Neurofeedback + BART/EEGBEHAVIORAL

10 sessions of emotional neurofeedback (max of 2 sessions per week and max of 10 weeks). Before (Baseline, Day 0) and at the study completion (after 10 neurofeedback sessions, Week 5), a EEG record is realized during the BART, assessing risk-taking behavior.

Neurofeedback and BART-EEG assessment
BART/EEG onlyBEHAVIORAL

only the twice EEG record are realized during the BART, assessing risk-taking behavior (every corresponding to the pre and post-neurofeedback evaluations in arm I)

BART-EEG assessment without neurofeedback

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects between 18 and 80 years old
  • Right-handed
  • Signed informed Consent Form
  • Subject affiliated to or beneficing from a French social security regime

You may not qualify if:

  • Subjects under 18 years old and over 80 years old
  • Left-handed
  • Pregnant woman
  • Subject beneficiary from a legal protection regime
  • Subject unlikely to cooperate or low cooperation stated by investigator
  • Subject not covered by social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besancon - Clinical Psychiatric Department

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Risk-TakingEmotional Regulation

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

BehaviorSelf-ControlSocial Behavior

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Central Study Contacts

Damien GABRIEL, PhD

CONTACT

+33 3 81 21 91 48dgabriel@chu-besancon.fr

Magali NICOLIER, PhD

CONTACT

+33 3 81 21 90 07mnicolier@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 19, 2022

Study Start

September 15, 2022

Primary Completion

July 15, 2023

Study Completion

September 15, 2023

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

FR(1)