Neurofeedback Training for Dyslexia

NCT ID: NCT04989088

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-06-30

Brief Summary

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The study aims at testing a Neurofeedback (NF) training specifically designed for inducing a functional hemispheric imbalance of the tempo-parietal regions in individuals with dyslexia. A randomized clinical trial aimed at comparing two experimental conditions is described: a) Left theta/beta NF training in combination with right beta/theta NF training and b) sham NF training.

Detailed Description

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Conditions

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Dyslexia Reading Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Left theta/beta and right beta/theta NF training

Group Type EXPERIMENTAL

ProComp5 Infiniti System w/BioGraph Infiniti Software

Intervention Type DEVICE

Left theta/beta NF training in combination with right beta/theta NF training in temporo-parietal regions, for 40 minutes (with a 20-minute break period)

Sham NF training

Group Type PLACEBO_COMPARATOR

ProComp5 Infiniti System w/recorded videos

Intervention Type DEVICE

Sham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period)

Interventions

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ProComp5 Infiniti System w/BioGraph Infiniti Software

Left theta/beta NF training in combination with right beta/theta NF training in temporo-parietal regions, for 40 minutes (with a 20-minute break period)

Intervention Type DEVICE

ProComp5 Infiniti System w/recorded videos

Sham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of dyslexia or reading performance 2 SD below the norm
* Average intelligence

Exclusion Criteria

* Psychiatric conditions
* Comorbidity with neurodevelopmental disorders
* Neurological disorders
* Epilepsy
* Enrollment in linguistic or literature university courses
Minimum Eligible Age

8 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Milan

OTHER

Sponsor Role collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Alice Cancer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Alice Cancer, PhD

Role: CONTACT

0272342284

References

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Cancer A, Vanutelli ME, Lucchiari C, Antonietti A. Using Neurofeedback to Restore Inter-Hemispheric Imbalance: A Study Protocol for Adults With Dyslexia. Front Psychol. 2021 Nov 5;12:768061. doi: 10.3389/fpsyg.2021.768061. eCollection 2021.

Reference Type DERIVED
PMID: 34803851 (View on PubMed)

Other Identifiers

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NF-DYSL

Identifier Type: -

Identifier Source: org_study_id

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