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

NCT05444816 | Completed

• 1 other identifier: MyMind_CIP_001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• change in Z-score of the trained EEG parameter(s) (power in any frequency bin 1-30 Hz). (Z before minus Z after the training) divided by the number of trained parameters; Z is the number of standard deviations away from the neurotypical average

  quantitative EEGs will be recorded at 4 times points, in Praxis Diana Siedek Vienna

  4 times, every three months: before training start; after ~3months of training; at the end of the active phase (i.e. after ~6 months total training) and after the follow-up phase (~3 months after the end of the active phase)

• change in absolute power value (squared microvolts) of the trained EEG parameter(s) (power in any frequency bin 1-30 Hz).

  quantitative EEGs will be recorded at 4 times points, in Praxis Diana Siedek Vienna

  4 times, every three months: before training start; after ~3months of training; at the end of the active phase (i.e. after ~6 months total training) and after the follow-up phase (~3 months after the end of the active phase)

• change in scores of the Social Responsiveness Scale 2 (and/or subscales)

  questionnaires will be filled in by the parents; total scores (raw) range between 0 and 195; lower scores represent a better outcome / higher scores represent a worse outcome

  4 times, every three months: before training start; after ~3months of training; at the end of the active phase (i.e. after ~6 months total training) and after the follow-up phase (~3 months after the end of the active phase)

• change in scores of the Behavioral Rating Inventory of Executive Function (and/or subscales)

  questionnaires will be filled in by the parents; total scores (raw) range between 0 and 258; lower scores represent a better outcome / higher scores represent a worse outcome

  4 times, every three months: before training start; after ~3months of training; at the end of the active phase (i.e. after ~6 months total training) and after the follow-up phase (~3 months after the end of the active phase)

Study Arms (1)

Personalised Neurofeedback training at home

EXPERIMENTAL

All patients will perform personalised neurofeedback training at home with the device Brainhero 2019, type 201

Device: Personalised Neurofeedback training at home

Interventions

Personalised Neurofeedback training at home DEVICE

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.

Personalised Neurofeedback training at home

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children or adolescents, male or female, aged 6-18 years, with an ASD diagnosis according to the DSM-5 or ICD-10, irrespective of IQ (IQ will be determined for each patient), with or without ADHD or epilepsy
• Signature on informed consent form
• Wireless internet connection for using the game and training
• Tablet or Smartphone for Brain Hero® training
• Confirmation that the child will be provided a quiet and undisturbed environment at home for playing Brain Hero® and that he/she is assisted by the caregiver with questions throughout play sessions to facilitate the game hero's flight in the direction of interest

You may not qualify if:

• Established diagnosis of schizophrenia, severe generalised anxiety disorder, major depression, or other neurological disorders
• Medical disorder requiring systemic chronic medication with confounding psychoactive effects
• Muscle spasms affecting the facial muscles and interfering with electrode measurements
• Inability to cope with qEEGs (sit still for a duration of 20 minutes) or inability to use the neurofeedback device (tablet use, headset set-up, understanding instructions)
• Plan to start other ASD treatments, including applied behaviour analysis (ABA), music therapy, dietary interventions etc. within the next 6 months
• Plan to start pharmacological treatment (medication) within the next 6 months
• Any estimated major events leading to changes in child routine planned in the next 6 months (e.g. school/kindergarten change, caregiver change, home move etc.)
• Pregnant and nursing mothers

Sponsors & Collaborators

• Brainhero GmbH: lead

Study Sites (2)

Praxis Jordangasse, Jordangasse 7A, Top 1/2

Vienna, 1010, Austria

Location

Brainhero GmbH

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nedjeljka Baldass, MD

  Praxis Jordangasse, Jordangasse 7, Top 1/2, 1010, Vienna, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 6, 2022
• Study Start: April 14, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)