DyslexiaNCT04989088
Neurofeedback Training for Dyslexia
A study testing ProComp5 Infiniti System w/BioGraph Infiniti Software and ProComp5 Infiniti System w/recorded videos in people with Dyslexia and Reading Problem, run by Catholic University of the Sacred Heart.
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. Read more about this study
- Who is it for?
- Ages 8 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia, Reading Problem
- What is being tested?
- ProComp5 Infiniti System w/BioGraph Infiniti Software and ProComp5 Infiniti System w/recorded videos
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of dyslexia or reading performance 2 SD below the norm
- Average intelligence
Who cannot join
- Psychiatric conditions
- Comorbidity with neurodevelopmental disorders
- Neurological disorders
- Epilepsy
- Enrollment in linguistic or literature university courses
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Dyslexia, Reading Problem
- Being tested
- ProComp5 Infiniti System w/BioGraph Infiniti Software, ProComp5 Infiniti System w/recorded videos
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
ProComp5 Infiniti System w/recorded videosDevice
Sham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period)
| Study group | Role | What they receive |
|---|---|---|
| Left theta/beta and right beta/theta NF training | Experimental | Not described Receives: Device: ProComp5 Infiniti System w/BioGraph Infiniti Software |
| Sham NF training | Placebo comparator | Not described Receives: Device: ProComp5 Infiniti System w/recorded videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG recording - ProComp5 Infiniti System
EEG power in theta/beta band recording in TP7 and TP8
Measured: 1 hour
Phonological task (Spironelli & Angrilli, 2006) accuracy
Computerized rhyme decision task - n. of errors
Measured: 1 hour
Phonological task (Spironelli & Angrilli, 2006) speed
Computerized rhyme decision task - response time (ms)
Measured: 1 hour
Semantic task (Spironelli & Angrilli, 2006) speed
Computerized semantic decision task - response time (ms)
Measured: 1 hour
Semantic task (Spironelli & Angrilli, 2006) accuracy
Computerized semantic decision task - n. of errors
Measured: 1 hour
Text reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Text reading speed measured in syllables / seconds
Measured: 1 hour
Text reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Text reading accuracy measured in n. of errors
Measured: 1 hour
Word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Word reading speed measured in syllables / seconds
Measured: 1 hour
Word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Word reading accuracy measured in n. of errors
Measured: 1 hour
Psuedo-word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Psuedo-word reading speed in syllables / seconds
Measured: 1 hour
Psuedo-word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Psuedo-word reading accuracy measured in n. of errors
Measured: 1 hour
Secondary outcomes (3)
Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)
Rapid automatized naming (RAN) speed measured in seconds
Measured: 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
Measured: 1 hour
Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV)
Digit forward and digit backword task
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Alice Cancer, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989088
- Sponsor's protocol ID
- NF-DYSL
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 34803851
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback Training to Restore Hemispheric Imbalance in Dyslexia
- ClinicalTrials.gov ID
- NCT04989088
- Acronym / sponsor ID
- NF-DYSL
- Conditions
- Dyslexia, Reading Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of dyslexia or reading performance 2 SD below the norm
- Average intelligence
Key exclusion criteria (5 listed)
- Psychiatric conditions
- Comorbidity with neurodevelopmental disorders
- Neurological disorders
- Epilepsy
- Enrollment in linguistic or literature university courses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProComp5 Infiniti System w/BioGraph Infiniti SoftwareLeft 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) | Device | Left theta/beta and right beta/theta NF training |
| ProComp5 Infiniti System w/recorded videosSham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period) | Device | Sham NF training |
Primary outcome
EEG recording - ProComp5 Infiniti System
Time frame: 1 hour
EEG power in theta/beta band recording in TP7 and TP8
Phonological task (Spironelli & Angrilli, 2006) accuracy
Time frame: 1 hour
Computerized rhyme decision task - n. of errors
Phonological task (Spironelli & Angrilli, 2006) speed
Time frame: 1 hour
Computerized rhyme decision task - response time (ms)
Semantic task (Spironelli & Angrilli, 2006) speed
Time frame: 1 hour
Computerized semantic decision task - response time (ms)
Semantic task (Spironelli & Angrilli, 2006) accuracy
Time frame: 1 hour
Computerized semantic decision task - n. of errors
Text reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Time frame: 1 hour
Text reading speed measured in syllables / seconds
Text reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Time frame: 1 hour
Text reading accuracy measured in n. of errors
Word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Time frame: 1 hour
Word reading speed measured in syllables / seconds
Word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Time frame: 1 hour
Word reading accuracy measured in n. of errors
Psuedo-word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Time frame: 1 hour
Psuedo-word reading speed in syllables / seconds
Psuedo-word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
Time frame: 1 hour
Psuedo-word reading accuracy measured in n. of errors
3 secondary outcomes
Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)
Time frame: 1 hour
Rapid automatized naming accuracy (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)
Time frame: 1 hour
Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV)
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 34803851Cancer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing ProComp5 Infiniti System w/BioGraph Infiniti Software and ProComp5 Infiniti System w/recorded videos in people with Dyslexia and Reading Problem, run by Catholic University of the Sacred Heart.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Cancer, PhD (0272342284, alice.cancer@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG recording - ProComp5 Infiniti System (time frame: 1 hour). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04989088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.