Neurofeedback Training for Dyslexia

Dyslexia Clinical Trial

Official title:

Neurofeedback Training to Restore Hemispheric Imbalance in Dyslexia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04989088
• Other study ID #: NF-DYSL
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: June 2022

Study information

• Verified date: July 2021
• Source: Catholic University of the Sacred Heart
• Contact: Alice Cancer, PhD
• Phone: 0272342284
• Email: alice.cancer[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslexia
• Reading Problem

Intervention

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)
• ProComp5 Infiniti System w/recorded videos
Sham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	University of Milan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG recording - ProComp5 Infiniti System	EEG power in theta/beta band recording in TP7 and TP8	1 hour
Primary	Phonological task (Spironelli & Angrilli, 2006) accuracy	Computerized rhyme decision task - n. of errors	1 hour
Primary	Phonological task (Spironelli & Angrilli, 2006) speed	Computerized rhyme decision task - response time (ms)	1 hour
Primary	Semantic task (Spironelli & Angrilli, 2006) speed	Computerized semantic decision task - response time (ms)	1 hour
Primary	Semantic task (Spironelli & Angrilli, 2006) accuracy	Computerized semantic decision task - n. of errors	1 hour
Primary	Text reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Text reading speed measured in syllables / seconds	1 hour
Primary	Text reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Text reading accuracy measured in n. of errors	1 hour
Primary	Word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Word reading speed measured in syllables / seconds	1 hour
Primary	Word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Word reading accuracy measured in n. of errors	1 hour
Primary	Psuedo-word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Psuedo-word reading speed in syllables / seconds	1 hour
Primary	Psuedo-word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)	Psuedo-word reading accuracy measured in n. of errors	1 hour
Secondary	Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)	Rapid automatized naming (RAN) speed measured in seconds	1 hour
Secondary	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
Secondary	Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV)	Digit forward and digit backword task	1 hour