MedTrace Logo

Brain Hero® Neurofeedback Training (With the Device Brainhero 2019, Type 201)

NCT05444816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-01-25

No results posted yet for this study

Summary

The study investigates the feasibility and the effects of training at home with personalised neurofeedback in children with an autism spectrum diagnosis and comorbidities. The personalisation relies on quantitative electroencephalography recordings performed in a clinic, which are also used to evaluate the efficiency of the home-based training, along with standardized questionnaires. The active phase is expected to last roughly 6 months, during which children are expected to complete multiple hours of training and complete an interim evaluation. Whether the training's effects are long lasting is evaluated in a follow-up phase, 3 months after the active phase.

Conditions

Interventions

DEVICE

Personalised Neurofeedback training at home

The already available Brain Hero® EEG device will be mailed to the subject's home, along with clear video instructions regarding its use (within the app), as previously established in a beta usability study with optimal results. All game training will take place at home, while the caregivers of patients will receive instructions either online or telephonically from the investigating team. The team is also ready with tips and tricks to keep the child motivated and facilitate the flight of the game hero in the direction of interest. Patients will be instructed to play a minimum of 20 min for four times a week, under supervision by their caregiver(s). Patients will be provided with a training plan, including all planned months of training and advanced examinations. Instructions will also be provided, verbally and written, and the investigating team will engage in video sessions or direct meetings with the parents to make sure all instructions are properly followed.

Sponsors & Collaborators

  • Brainhero GmbH

    lead INDUSTRY

Principal Investigators

  • Nedjeljka Baldass, MD · Praxis Jordangasse, Jordangasse 7, Top 1/2, 1010, Vienna, Austria

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05444816 on ClinicalTrials.gov