NCT05924659

Brief Summary

This randomised, double bling and controled study aim to evaluate the performance of a neurofeedback training on attentional capabilities, in comparison to placebo. We hypothesize 1) that an electroencephalographic (EEG) based neurofeedback training may improve attentional performances of healthy subjects, and 2) inter-individual variability might be explained by factors such as body awarness, sleep parameters and genetics of individuals.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

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

June 12, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

June 25, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 12, 2023

Last Update Submit

June 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Attentional performance

    the Attentional Network Task (Reaction Times (RT) in ms of Incongruent trials minus Reaction Times of Congruent trials : RTincongruent - Rtcongruent).

    One week

Secondary Outcomes (1)

  • Sleep parameters

    One week

Study Arms (2)

Neurofeedback Training

EXPERIMENTAL

1 week of cerebral training with a neurofeedback strategy based on increased alpha EEG activity

Other: Cerabral training

Control

SHAM COMPARATOR

1 week of cerebral training with a strategy based on time on task increase of performance, without neurofeedback

Other: Cerabral training

Interventions

1 week of cerebral training (neurofeedback or sham)

ControlNeurofeedback Training

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male or female volunteers
  • aged between 18 yo and 50 yo.

You may not qualify if:

  • any pathological issues,
  • previous traumatic brain and/or auditive injuries,
  • volunteers having already experienced NFB trainings,
  • high tobacco consumers,
  • volunteers refusing genotyping.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut de recherche biomédicale des armées

Brétigny-sur-Orge, 91223, France

RECRUITING

Hotel Dieu

Paris, 75004, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Fabien SAUVET, MD

CONTACT

Fabien SAUVET, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double bling computizded neurofeed back training
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized assigment, neurofeedback training versus control
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 29, 2023

Study Start

June 25, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations