NCT04989088

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 15, 2021

Last Update Submit

July 24, 2021

Conditions

DyslexiaReading Problem

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (3)

  • Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)

    1 hour

  • Rapid automatized naming accuracy (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)

    1 hour

  • Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV)

    1 hour

Study Arms (2)

Left theta/beta and right beta/theta NF training

EXPERIMENTAL
Device: ProComp5 Infiniti System w/BioGraph Infiniti Software

Sham NF training

PLACEBO COMPARATOR
Device: ProComp5 Infiniti System w/recorded videos

Interventions

ProComp5 Infiniti System w/BioGraph Infiniti SoftwareDEVICE

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)

Left theta/beta and right beta/theta NF training
ProComp5 Infiniti System w/recorded videosDEVICE

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

Sham NF training

Eligibility Criteria

Age8 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Psychiatric conditions
  • Comorbidity with neurodevelopmental disorders
  • Neurological disorders
  • Epilepsy
  • Enrollment in linguistic or literature university courses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34803851DERIVED

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Alice Cancer, PhD

CONTACT

0272342284alice.cancer@unicatt.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2021

First Posted

August 4, 2021

Study Start

October 1, 2021

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

August 4, 2021

Record last verified: 2021-07