Neurofeedback Training for Dyslexia

Neurofeedback Training to Restore Hemispheric Imbalance in Dyslexia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyslexia; Reading Problem
• Intervention / Treatment: Device: ProComp5 Infiniti System w/BioGraph Infiniti Software; Device: ProComp5 Infiniti System w/recorded videos

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice Cancer, PhD; Phone Number: 0272342284; Email: alice.cancer@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Left theta/beta and right beta/theta NF training	Device: 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)
PLACEBO_COMPARATOR: Sham NF training	Device: ProComp5 Infiniti System w/recorded videos; Sham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG recording - ProComp5 Infiniti System	EEG power in theta/beta band recording in TP7 and TP8	1 hour
Phonological task (Spironelli & Angrilli, 2006) accuracy	Computerized rhyme decision task - n. of errors	1 hour
Phonological task (Spironelli & Angrilli, 2006) speed	Computerized rhyme decision task - response time (ms)	1 hour
Semantic task (Spironelli & Angrilli, 2006) speed	Computerized semantic decision task - response time (ms)	1 hour
Semantic task (Spironelli & Angrilli, 2006) accuracy	Computerized semantic decision task - n. of errors	1 hour
Text reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Text reading speed measured in syllables / seconds	1 hour
Text reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Text reading accuracy measured in n. of errors	1 hour
Word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Word reading speed measured in syllables / seconds	1 hour
Word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Word reading accuracy measured in n. of errors	1 hour
Psuedo-word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Psuedo-word reading speed in syllables / seconds	1 hour
Psuedo-word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Psuedo-word reading accuracy measured in n. of errors	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)	Rapid automatized naming (RAN) speed measured in seconds	1 hour
Rapid automatized naming accuracy (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)	Rapid automatized naming (RAN) accuracy measures in n. of errors	1 hour
Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV)	Digit forward and digit backword task	1 hour

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: University of Milan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 24, 2021
• First Posted (ACTUAL): August 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 24, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: NF-DYSL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes