DyslexiaNCT04244578
Transcranial Direct Current Stimulation in the Treatment of Dyslexia.
A study testing Active tDCS in people with Dyslexia, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
The present study grounds on the absence of evidence-based treatment in individuals with dyslexia. At this topic, the present study will explore the potential effect of transcranial direct current stimulation (tDCS) over parieto-occipital brain regions, cerebral areas usually disrupted in individuals with dyslexia. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Dyslexia
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2016to 1 Feb 2021
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents with dyslexia (DSM-5, APA 2013)
- IQ ≥ 85
Who cannot join
- Having a comorbidity with an important medical conditions;
- Having neurological diseases;
- Having Epilepsy o family history of epilepsy;
- Receiving a treatment for dyslexia in the previous three months before the baseline screening;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation in the Treatment of Dyslexia: a Randomized Double-blind Study.
The present study grounds on the absence of evidence-based treatment in individuals with dyslexia. At this topic, the present study will explore the potential effect of transcranial direct current stimulation (tDCS) over parieto-occipital brain regions, cerebral areas usually disrupted in individuals with dyslexia. tDCS will be administered without concomitantly training.
Therefore, the investigators hypothesized that active tDCS over parieto-occipital areas will enhance reading skills in children and adolescents with dyslexia. On the contrary, sham tDCS (placebo) over parieto-occipital areas will not have significant effect on reading. Further, both active and sham tDCS will be safe and well-tolerated.
Read the detailed description
The study design is randomized stratified, cross-over, double-blind, placebo-controlled.
Children and adolescents with dyslexia will be selected and randomly assigned to two different groups: 1. Active tDCS over parieto-occipital areas + sham tDCS over parieto-occipital areas (Active-Sham tDCS); 2. Sham tDCS over parieto-occipital areas + active tDCS over parieto-occipital areas (Sham-Active tDCS).
In this project, the investigators will work to understand whether a brain-based intervention, with the use of tDCS without combined training, can enhance reading in individuals with dyslexia.
The protocol will allow the investigators to:
- Testing the efficacy of stand-alone tDCS in enhancing reading in individuals with dyslexia;
- Testing the critical role of brain regions (parieto-occipital areas) usually involved in reading and disrupted in dyslexia;
- Predicting outcomes based on reading-related skills;
- Investigating the safety and tolerability of tDCS;
The overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in dyslexia.
- Conditions
- Dyslexia
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- tDCS, transcranial direct current stimulation, transcranial electric stimulation, developmental dyslexia, specific learning disorders, treatment
- Medical subject headings
- Dyslexia, Specific Learning Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Also called Brainstim Active tDCS
Active tDCS will be delivered to parieto-occipital areas for five consecutive days. tDCS will be delivered by a battery driven, direct current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left (anodal) and right (cathodal) parieto-occipital areas, PO7 and PO8 position according to the 10-20 international EEG system for electrode placement. Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min.
Sham tDCSDevice
Also called Brainstim Sham tDCS
Sham tDCS will be delivered to parieto-occipital areas for five consecutive days. tDCS will be delivered by a battery driven, direct current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left (anodal) and right (cathodal) parieto-occipital areas, PO7 and PO8 position according to the 10-20 international EEG system for electrode placement. Stimulation intensity will be set at 1 milliampere (mA), but the current will be applied for 30 s and will be ramped down without the participants awareness.
| Study group | Role | What they receive |
|---|---|---|
| Active-Sham tDCS | Experimental | Each tDCS sessions will be delivered for 5 days for a total of non consecutive two weeks. The first session will be active tDCS and two months after, a sham tDCS will follow. Receives: Device: Active tDCS; Device: Sham tDCS |
| Sham-Active tDCS | Active comparator | Each tDCS sessions (sham tDCS and active tDCS) will be delivered for 5 days for a total of non consecutive two weeks.
The first session will be sham tDCS and two months after, an active tDCS will follow. Receives: Device: Active tDCS; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-word reading speed
The proportion of patients with change of at least 0.06 sill/sec in the non-word reading speed following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Secondary outcomes (10)
Non-word reading accuracy
The proportion of patients with change in the non-word reading accuracy following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Word reading speed
The proportion of patients with change in the word reading speed following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Word reading accuracy
The proportion of patients with change in the word reading accuracy following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Text reading speed
The proportion of patients with change in the text reading speed following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Text reading accuracy
The proportion of patients with change in the text reading accuracy following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Verbal and visuo-spatial n-back
The proportion of patients with change in the index of verbal and visuo-spatial working memory (more score means better outcome) following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Phoneme Blending
The proportion of patients with change in the index of phoneme blending (more score means better outcome) following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Rapid Automatized Naming of color and letters
The proportion of patients with change in the accuracy and speed of Rapid Automatized Naming of color and letters following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Lexical Decision
The proportion of patients with change in the accuracy and speed of Lexical decision following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Questionnaire of safety and tolerability (Questionnaire of adverse effect)
The proportion of patients with change in the questionnaire of safety and tolerability (Questionnaire of adverse effect; Brunoni et al., 2011) following Active tDCS sessions will be the same than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
Measured: up to one month after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 May 2016
- Primary completion1 Sep 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deny Menghini, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244578
- Sponsor's protocol ID
- 201201X002931
- Status last verified
- Jul 2021
- First submitted
- 25 Jan 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Consensus Conference, Disturbi Specifici dell'apprendimento, ISS, 2011.
Tressoldi P.E. L'evoluzione della lettura e scrittura dalla 2 elementare alla 3 media. Dati per un modello di sviluppo e per la diagnosi di disturbo specifico.Età Evolutiva, 53 - pp. 43-55, 1996
Sartori G., Job R. e Tressoldi P.E. (2007), DDE-2. Batteria per la valutazione della dislessia e della disortografia evolutiva, Firenze, Organizzazioni Speciali.
Cornoldi C. e Colpo G. (1998), Prove di Lettura MT per la Scuola Elementare-2, Firenze, Organizzazioni Speciali.
Belacchi, C., Scalisi, T.G., Cannoni, E. e Cornoldi, C. (2008). Matrici Progressive di Raven Forma Colore (CPM-47). Manuale d'uso e standardizzazione italiana. Firenze, Organizzazioni Speciali.
Achenbach, T.M., & Rescorla, L.A. (2001). Manual for the ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
Calvino, I. (1966). Marcovaldo ovvero le stagioni in città. Torino: Einaudi.
Shaywitz BA, Shaywitz SE, Pugh KR, Mencl WE, Fulbright RK, Skudlarski P, Constable RT, Marchione KE, Fletcher JM, Lyon GR, Gore JC. Disruption of posterior brain systems for reading in children with developmental dyslexia. Biol Psychiatry. 2002 Jul 15;52(2):101-10. doi: 10.1016/s0006-3223(02)01365-3.
PubMed 12114001Temple E, Deutsch GK, Poldrack RA, Miller SL, Tallal P, Merzenich MM, Gabrieli JD. Neural deficits in children with dyslexia ameliorated by behavioral remediation: evidence from functional MRI. Proc Natl Acad Sci U S A. 2003 Mar 4;100(5):2860-5. doi: 10.1073/pnas.0030098100. Epub 2003 Feb 25.
PubMed 12604786Hoeft F, McCandliss BD, Black JM, Gantman A, Zakerani N, Hulme C, Lyytinen H, Whitfield-Gabrieli S, Glover GH, Reiss AL, Gabrieli JD. Neural systems predicting long-term outcome in dyslexia. Proc Natl Acad Sci U S A. 2011 Jan 4;108(1):361-6. doi: 10.1073/pnas.1008950108. Epub 2010 Dec 20.
PubMed 21173250Hoeft F, Hernandez A, McMillon G, Taylor-Hill H, Martindale JL, Meyler A, Keller TA, Siok WT, Deutsch GK, Just MA, Whitfield-Gabrieli S, Gabrieli JD. Neural basis of dyslexia: a comparison between dyslexic and nondyslexic children equated for reading ability. J Neurosci. 2006 Oct 18;26(42):10700-8. doi: 10.1523/JNEUROSCI.4931-05.2006.
PubMed 17050709Shaywitz SE, Shaywitz BA, Pugh KR, Fulbright RK, Constable RT, Mencl WE, Shankweiler DP, Liberman AM, Skudlarski P, Fletcher JM, Katz L, Marchione KE, Lacadie C, Gatenby C, Gore JC. Functional disruption in the organization of the brain for reading in dyslexia. Proc Natl Acad Sci U S A. 1998 Mar 3;95(5):2636-41. doi: 10.1073/pnas.95.5.2636.
PubMed 9482939Bakker DJ. Treatment of developmental dyslexia: a review. Pediatr Rehabil. 2006 Jan-Mar;9(1):3-13. doi: 10.1080/13638490500065392.
PubMed 16352500Simos PG, Fletcher JM, Bergman E, Breier JI, Foorman BR, Castillo EM, Davis RN, Fitzgerald M, Papanicolaou AC. Dyslexia-specific brain activation profile becomes normal following successful remedial training. Neurology. 2002 Apr 23;58(8):1203-13. doi: 10.1212/wnl.58.8.1203.
PubMed 11971088Stuss DT. The future of cognitive neurorehabilitation. Neuropsychol Rehabil. 2011 Oct;21(5):755-68. doi: 10.1080/09602011.2011.605590. Epub 2011 Sep 27.
PubMed 21950776
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in the Treatment of Dyslexia: a Randomized Double-blind Study.
- ClinicalTrials.gov ID
- NCT04244578
- Acronym / sponsor ID
- 201201X002931
- Conditions
- Dyslexia
- Keywords
- tDCS, transcranial direct current stimulation, transcranial electric stimulation, developmental dyslexia, specific learning disorders, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 28 Jan 2020 (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 present study grounds on the absence of evidence-based treatment in individuals with dyslexia. At this topic, the present study will explore the potential effect of transcranial direct current stimulation (tDCS) over parieto-occipital brain regions, cerebral areas usually disrupted in individuals with dyslexia. tDCS will be administered without concomitantly training.
Therefore, the investigators hypothesized that active tDCS over parieto-occipital areas will enhance reading skills in children and adolescents with dyslexia. On the contrary, sham tDCS (placebo) over parieto-occipital areas will not have significant effect on reading. Further, both active and sham tDCS will be safe and well-tolerated.
Detailed description
The study design is randomized stratified, cross-over, double-blind, placebo-controlled.
Children and adolescents with dyslexia will be selected and randomly assigned to two different groups: 1. Active tDCS over parieto-occipital areas + sham tDCS over parieto-occipital areas (Active-Sham tDCS); 2. Sham tDCS over parieto-occipital areas + active tDCS over parieto-occipital areas (Sham-Active tDCS).
In this project, the investigators will work to understand whether a brain-based intervention, with the use of tDCS without combined training, can enhance reading in individuals with dyslexia.
The protocol will allow the investigators to:
- Testing the efficacy of stand-alone tDCS in enhancing reading in individuals with dyslexia;
- Testing the critical role of brain regions (parieto-occipital areas) usually involved in reading and disrupted in dyslexia;
- Predicting outcomes based on reading-related skills;
- Investigating the safety and tolerability of tDCS;
The overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in dyslexia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active-Sham tDCS | Experimental | Device: Active tDCS, Device: Sham tDCSEach tDCS sessions will be delivered for 5 days for a total of non consecutive two weeks. The first session will be active tDCS and two months after, a sham tDCS will follow. |
| Sham-Active tDCS | Active comparator | Device: Active tDCS, Device: Sham tDCSEach tDCS sessions (sham tDCS and active tDCS) will be delivered for 5 days for a total of non consecutive two weeks. The first session will be sham tDCS and two months after, an active tDCS will follow. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children and adolescents with dyslexia (DSM-5, APA 2013)
- IQ ≥ 85
Key exclusion criteria (4 listed)
- Having a comorbidity with an important medical conditions;
- Having neurological diseases;
- Having Epilepsy o family history of epilepsy;
- Receiving a treatment for dyslexia in the previous three months before the baseline screening;
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 |
|---|---|---|
| Active tDCSAlso: Brainstim Active tDCSActive tDCS will be delivered to parieto-occipital areas for five consecutive days. tDCS will be delivered by a battery driven, direct current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left (anodal) and right (cathodal) parieto-occipital areas, PO7 and PO8 position according to the 10-20 international EEG system for electrode placement. Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min. | Device | Active-Sham tDCS, Sham-Active tDCS |
| Sham tDCSAlso: Brainstim Sham tDCSSham tDCS will be delivered to parieto-occipital areas for five consecutive days. tDCS will be delivered by a battery driven, direct current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left (anodal) and right (cathodal) parieto-occipital areas, PO7 and PO8 position according to the 10-20 international EEG system for electrode placement. Stimulation intensity will be set at 1 milliampere (mA), but the current will be applied for 30 s and will be ramped down without the participants awareness. | Device | Active-Sham tDCS, Sham-Active tDCS |
Primary outcome
Non-word reading speed
Time frame: up to one month after the end of the intervention
The proportion of patients with change of at least 0.06 sill/sec in the non-word reading speed following Active tDCS sessions than after Sham tDCS sessions both in ActiveSham tDCS and ShamActive tDCS.
10 secondary outcomes
Non-word reading accuracy
Time frame: up to one month after the end of the intervention
Word reading speed
Time frame: up to one month after the end of the intervention
Word reading accuracy
Time frame: up to one month after the end of the intervention
Text reading speed
Time frame: up to one month after the end of the intervention
Text reading accuracy
Time frame: up to one month after the end of the intervention
Verbal and visuo-spatial n-back
Time frame: up to one month after the end of the intervention
Phoneme Blending
Time frame: up to one month after the end of the intervention
Rapid Automatized Naming of color and letters
Time frame: up to one month after the end of the intervention
Lexical Decision
Time frame: up to one month after the end of the intervention
Questionnaire of safety and tolerability (Questionnaire of adverse effect)
Time frame: up to one month after the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- BackgroundConsensus Conference, Disturbi Specifici dell'apprendimento, ISS, 2011.
- BackgroundTressoldi P.E. L'evoluzione della lettura e scrittura dalla 2 elementare alla 3 media. Dati per un modello di sviluppo e per la diagnosi di disturbo specifico.Età Evolutiva, 53 - pp. 43-55, 1996
- BackgroundSartori G., Job R. e Tressoldi P.E. (2007), DDE-2. Batteria per la valutazione della dislessia e della disortografia evolutiva, Firenze, Organizzazioni Speciali.
- BackgroundCornoldi C. e Colpo G. (1998), Prove di Lettura MT per la Scuola Elementare-2, Firenze, Organizzazioni Speciali.
- BackgroundBelacchi, C., Scalisi, T.G., Cannoni, E. e Cornoldi, C. (2008). Matrici Progressive di Raven Forma Colore (CPM-47). Manuale d'uso e standardizzazione italiana. Firenze, Organizzazioni Speciali.
- BackgroundAchenbach, T.M., & Rescorla, L.A. (2001). Manual for the ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
- BackgroundCalvino, I. (1966). Marcovaldo ovvero le stagioni in città. Torino: Einaudi.
- Results publication: PubMed 12114001Shaywitz BA, Shaywitz SE, Pugh KR, Mencl WE, Fulbright RK, Skudlarski P, Constable RT, Marchione KE, Fletcher JM, Lyon GR, Gore JC. Disruption of posterior brain systems for reading in children with developmental dyslexia. Biol Psychiatry. 2002 Jul 15;52(2):101-10. doi: 10.1016/s0006-3223(02)01365-3.
- Results publication: PubMed 12604786Temple E, Deutsch GK, Poldrack RA, Miller SL, Tallal P, Merzenich MM, Gabrieli JD. Neural deficits in children with dyslexia ameliorated by behavioral remediation: evidence from functional MRI. Proc Natl Acad Sci U S A. 2003 Mar 4;100(5):2860-5. doi: 10.1073/pnas.0030098100. Epub 2003 Feb 25.
- Results publication: PubMed 21173250Hoeft F, McCandliss BD, Black JM, Gantman A, Zakerani N, Hulme C, Lyytinen H, Whitfield-Gabrieli S, Glover GH, Reiss AL, Gabrieli JD. Neural systems predicting long-term outcome in dyslexia. Proc Natl Acad Sci U S A. 2011 Jan 4;108(1):361-6. doi: 10.1073/pnas.1008950108. Epub 2010 Dec 20.
- Results publication: PubMed 17050709Hoeft F, Hernandez A, McMillon G, Taylor-Hill H, Martindale JL, Meyler A, Keller TA, Siok WT, Deutsch GK, Just MA, Whitfield-Gabrieli S, Gabrieli JD. Neural basis of dyslexia: a comparison between dyslexic and nondyslexic children equated for reading ability. J Neurosci. 2006 Oct 18;26(42):10700-8. doi: 10.1523/JNEUROSCI.4931-05.2006.
- Results publication: PubMed 9482939Shaywitz SE, Shaywitz BA, Pugh KR, Fulbright RK, Constable RT, Mencl WE, Shankweiler DP, Liberman AM, Skudlarski P, Fletcher JM, Katz L, Marchione KE, Lacadie C, Gatenby C, Gore JC. Functional disruption in the organization of the brain for reading in dyslexia. Proc Natl Acad Sci U S A. 1998 Mar 3;95(5):2636-41. doi: 10.1073/pnas.95.5.2636.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Dyslexia, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-word reading speed (time frame: up to one month after the end of the intervention). 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 NCT04244578, which also lists 41 linked publications.
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 23 Jul 2021.