Childhood Apraxia of SpeechNCT05675306
Dose Frequency RCT on DTTC in Children With CAS
A study testing Dynamic Temporal and Tactile Cueing Treatment in people with Childhood Apraxia of Speech, run by Marquette University at 1 site in United States.
Trial summary
Childhood apraxia of speech (CAS) is a pediatric motor-based speech sound disorder that requires a specialized approach to intervention (Maas et al., 2014). The extant literature on the treatment of CAS commonly recommends intensive treatment using a motor-based approach, with some of the best evidence supporting the… Read more about this study
- Who is it for?
- Ages 30 months to 95 years
- Conditions the study is for
- Childhood Apraxia of Speech
- What is being tested?
- Dynamic Temporal and Tactile Cueing Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 months to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CAS diagnosis confirmed by research team as described below (e.g., Iuzzini-Seigel et al., 2022; Shriberg et al., 2017; Strand \& McCauley, 2019),
- 2;6-7;11 years of age at treatment commencement;
- English as the primary language;
Who cannot join
- concomitant developmental disorders (including autism, global developmental delay, intellectual disability);
- diagnosis of severe or primary dysarthria as described below;
- palatal or structural orofacial anomalies as described below,
- uncorrected vision impairment
- hearing loss;
- receiving speech treatment elsewhere over the course of this study, although language, augmentative and alternative communication treatment, or similar non-speech treatment, would be permitted
Show all 9Show fewer
- Receptive Language Index standard score less than 70 on the Receptive-Expressive Emergent Language Test, 4th edition (REEL-4; Brown et al., 2020) for children 2-3 years of age, the Clinical Evaluation of Language Fundamentals - Preschool 3rd edition (CELF-P3; Wiig et al., 2020) for children 4-5 years of age, or the Clinical Evaluation of Language Fundamentals - 5th edition (CELF-5; Wiig et al., 2013) for children 6-7 years of age,
- Nonverbal Index standard score less than 70 on the Reynolds Intellectual Assessment Scales- 2nd edition, Remote (Reynolds \& Kamphaus, 2015), and
- no evidence of communicative intent, attempts at verbal communication, focused attention to the clinician's face, or demonstrated ability to imitate during the DEMSS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Frequency Randomized Control Trial for Dynamic Temporal and Tactile Cueing (DTTC) Treatment for Childhood Apraxia of Speech
Childhood apraxia of speech (CAS) is a pediatric motor-based speech sound disorder that requires a specialized approach to intervention (Maas et al., 2014). The extant literature on the treatment of CAS commonly recommends intensive treatment using a motor-based approach, with some of the best evidence supporting the use of Dynamic Temporal and Tactile Cueing (DTTC; Strand, 2020). To date, a rigorous and systematic comparison of high and low dose frequency has not been undertaken for DTTC, resulting in a lack of evidence to guide decisions about the optimal treatment schedule for this intervention. The current study aims to fill this gap in knowledge by comparing treatment outcomes when dose frequency is varied.
The goal of this clinical trial is to determine whether the number of treatment sessions per week has an effect on intervention outcomes in 60 children with CAS. The main question this research will address is whether whole word accuracy will differ between two groups of children undergoing DTTC treatment when one group of children receives treatment twice a week for 12 weeks and the other group receives treatment 4 times a week for 6 weeks. Community clinicians will administer all treatment sessions.
Read the detailed description
Sixty children with childhood apraxia of speech will be treated with DTTC treatment. A Phase III randomized controlled trial with parallel groups will be conducted to compare effects of low versus high dose frequency on DTTC treatment outcomes in children with CAS. Children with CAS between 2;5-7;11 years of age will be recruited to participate in this study. Treatment will be provided in the community setting by speech-language pathologists who have completed specialized training administering DTTC in a research reliable manner.
True randomization with concealed allocation will be used to assign children to either the low or high dose frequency group. Treatment will be administered in 1-hour sessions either 4 times per week over a 6-week period (high dose) or 2 times per week over a 12-week period (low dose) for a total of 24 hours per child. To measure treatment gains, probe data will be collected before treatment, during treatment, and 1 day, 1 week, 4 weeks, and 12 weeks post-treatment. Probe data will consist of customized treated words and a standard set of untreated words to assess generalization of treatment gains. The primary outcome variable will be whole word accuracy, a measure of segmental, phonotactic, and suprasegmental accuracy.
This will be the first randomized controlled trial (RCT) to evaluate dose frequency for DTTC treatment in children with CAS.
- Conditions
- Childhood Apraxia of Speech
- Being tested
- Dynamic Temporal and Tactile Cueing Treatment
- Keywords
- treatment, dose frequency, speech sound disorders, cumulative dosage, whole word accuracy, Dynamic Temporal and Tactile Cueing, DTTC, Childhood apraxia of speech
- Medical subject headings
- Apraxias, Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Temporal and Tactile Cueing TreatmentBehavioural
Also called DTTC
DTTC is a dynamic, motor-based treatment approach designed for children with severe CAS. This approach is based on Integral Stimulation (Edeal \& Gildersleeve-Neumann, 2011; Maas \& Farinella, 2012; Maas et al., 2019; Strand \& Debertine, 2000; Strand \& Skinder, 1999), in which the clinician instructs the child to "listen to me, watch me, and do what I do" and systematically taxes and supports the speech motor system to facilitate system-wide change in speech output (Strand, 2020).
| Study group | Role | What they receive |
|---|---|---|
| High Dose Frequency | Experimental | This group will receive treatment 4x/week for 6 weeks Receives: Behavioral: Dynamic Temporal and Tactile Cueing Treatment |
| Low Dose Frequency | Active comparator | This group will receive treatment 2x/week for 12 weeks Receives: Behavioral: Dynamic Temporal and Tactile Cueing Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to whole word accuracy
A multi-factor whole word accuracy measure (Multilevel word Accuracy Composite Scale; Case et al., under review) that systematically accounts for segmental and prosodic accuracy, word shape maintenance, and smoothness and fluency of movement transitions will be calculated on treated and similar untreated words in the generalization probe.
Measured: Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
Secondary outcomes (3)
Phoneme accuracy
Percentage of phonemes correct on the generalization probe
Measured: Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
Speech Intelligibility
Calculated based on the Intelligibility in Context Scale (McLeod et al., 2012), a parent survey measure
Measured: Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post completion of treatment)
Functional communication
Calculated based on the Functional Outcomes on Communication Under Six (Thomas-Stonell et al., 2015), a parent survey measure
Measured: Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Mar 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Childhood Apraxia of SpeechStudies 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
- Model description
- The proposed work is multisite Phase III parallel-group RCT that aims to investigate the outcomes of DTTC in children with CAS and determine whether dose frequency impacts response to treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Collaborators
- Hofstra University, New York University, University of Vermont, University of Sydney, Remarkable Speech and Movement
- Responsible party
- Principal investigator, Jenya Iuzzini-Seigel, Marquette University
- Investigators
- Jenya Iuzzini-Seigel, PhD, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675306
- Sponsor's protocol ID
- 75245
- Status last verified
- May 2025
- First submitted
- 22 Dec 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual level data will be shared.
Publications
Wiig, E. H., Secord, W. A., & Semel, E. M. (2020). Clinical Evaluation of Language Fundamentals - Preschool (3rd ed.). Pearson.
Strand EA. Dynamic Temporal and Tactile Cueing: A Treatment Strategy for Childhood Apraxia of Speech. Am J Speech Lang Pathol. 2020 Feb 7;29(1):30-48. doi: 10.1044/2019_AJSLP-19-0005. Epub 2019 Dec 17.
PubMed 31846588Maas E, Gildersleeve-Neumann C, Jakielski KJ, Stoeckel R. Motor-based intervention protocols in treatment of childhood apraxia of speech (CAS). Curr Dev Disord Rep. 2014 Sep;1(3):197-206. doi: 10.1007/s40474-014-0016-4.
PubMed 25313348Edeal DM, Gildersleeve-Neumann CE. The importance of production frequency in therapy for childhood apraxia of speech. Am J Speech Lang Pathol. 2011 May;20(2):95-110. doi: 10.1044/1058-0360(2011/09-0005). Epub 2011 Feb 17.
PubMed 21330650Maas E, Farinella KA. Random versus blocked practice in treatment for childhood apraxia of speech. J Speech Lang Hear Res. 2012 Apr;55(2):561-78. doi: 10.1044/1092-4388(2011/11-0120). Epub 2011 Dec 29.
PubMed 22207698Maas E, Gildersleeve-Neumann C, Jakielski K, Kovacs N, Stoeckel R, Vradelis H, Welsh M. Bang for Your Buck: A Single-Case Experimental Design Study of Practice Amount and Distribution in Treatment for Childhood Apraxia of Speech. J Speech Lang Hear Res. 2019 Sep 20;62(9):3160-3182. doi: 10.1044/2019_JSLHR-S-18-0212. Epub 2019 Aug 19.
PubMed 31425660Iuzzini-Seigel J, Allison KM, Stoeckel R. A Tool for Differential Diagnosis of Childhood Apraxia of Speech and Dysarthria in Children: A Tutorial. Lang Speech Hear Serv Sch. 2022 Oct 6;53(4):926-946. doi: 10.1044/2022_LSHSS-21-00164. Epub 2022 May 6.
PubMed 35523425Shriberg LD, Strand EA, Fourakis M, Jakielski KJ, Hall SD, Karlsson HB, Mabie HL, McSweeny JL, Tilkens CM, Wilson DL. A Diagnostic Marker to Discriminate Childhood Apraxia of Speech From Speech Delay: Introduction. J Speech Lang Hear Res. 2017 Apr 14;60(4):S1094-S1095. doi: 10.1044/2016_JSLHR-S-16-0148.
PubMed 28384695Goldman, R., & Fristoe, M. (2015). Goldman-Fristoe Test of Articulation - Third Edition (GFTA-3). Pearson Assessments.
Strand, E. A., & Debertine, P. (2000). The efficacy of integral stimulation intervention with developmental apraxia of speech. Journal of Medical Speech-Language Pathology, 8(4), 295-300.
Strand, E. A., & McCauley, R. J. (2019). The Dynamic Evaluation of Motor Speech Skill (DEMSS). Brookes.
Thomas-Stonell, N., Oddson, B., Robertson, B., Walker, J. & Rosenbaum, P. (2015). The FOCUS©-34: Focus on the Outcomes of Communication Under Six. Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON. http://www.focusoutcomemeasurement.ca
Wiig, E. H., Semel, E. M., & Secord, W. A. (2013). Clinical Evaluation of Language Fundamentals - 5. Pearson.
Iuzzini-Seigel J, Case J, Grigos MI, Velleman SL, Thomas D, Murray E. Dose frequency randomized controlled trial for Dynamic Temporal and Tactile Cueing (DTTC) treatment for childhood apraxia of speech: protocol paper. BMC Pediatr. 2023 May 25;23(1):263. doi: 10.1186/s12887-023-04066-2.
PubMed 37226208
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Frequency Randomized Control Trial for Dynamic Temporal and Tactile Cueing (DTTC) Treatment for Childhood Apraxia of Speech
- ClinicalTrials.gov ID
- NCT05675306
- Acronym / sponsor ID
- 75245
- Conditions
- Childhood Apraxia of Speech
- Keywords
- treatment, dose frequency, speech sound disorders, cumulative dosage, whole word accuracy, Dynamic Temporal and Tactile Cueing, DTTC, Childhood apraxia of speech
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Collaborators
- Hofstra University, New York University, University of Vermont, University of Sydney, Remarkable Speech and Movement
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jan 2023 (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.
Childhood apraxia of speech (CAS) is a pediatric motor-based speech sound disorder that requires a specialized approach to intervention (Maas et al., 2014). The extant literature on the treatment of CAS commonly recommends intensive treatment using a motor-based approach, with some of the best evidence supporting the use of Dynamic Temporal and Tactile Cueing (DTTC; Strand, 2020). To date, a rigorous and systematic comparison of high and low dose frequency has not been undertaken for DTTC, resulting in a lack of evidence to guide decisions about the optimal treatment schedule for this intervention. The current study aims to fill this gap in knowledge by comparing treatment outcomes when dose frequency is varied.
The goal of this clinical trial is to determine whether the number of treatment sessions per week has an effect on intervention outcomes in 60 children with CAS. The main question this research will address is whether whole word accuracy will differ between two groups of children undergoing DTTC treatment when one group of children receives treatment twice a week for 12 weeks and the other group receives treatment 4 times a week for 6 weeks. Community clinicians will administer all treatment sessions.
Detailed description
Sixty children with childhood apraxia of speech will be treated with DTTC treatment. A Phase III randomized controlled trial with parallel groups will be conducted to compare effects of low versus high dose frequency on DTTC treatment outcomes in children with CAS. Children with CAS between 2;5-7;11 years of age will be recruited to participate in this study. Treatment will be provided in the community setting by speech-language pathologists who have completed specialized training administering DTTC in a research reliable manner.
True randomization with concealed allocation will be used to assign children to either the low or high dose frequency group. Treatment will be administered in 1-hour sessions either 4 times per week over a 6-week period (high dose) or 2 times per week over a 12-week period (low dose) for a total of 24 hours per child. To measure treatment gains, probe data will be collected before treatment, during treatment, and 1 day, 1 week, 4 weeks, and 12 weeks post-treatment. Probe data will consist of customized treated words and a standard set of untreated words to assess generalization of treatment gains. The primary outcome variable will be whole word accuracy, a measure of segmental, phonotactic, and suprasegmental accuracy.
This will be the first randomized controlled trial (RCT) to evaluate dose frequency for DTTC treatment in children with CAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed work is multisite Phase III parallel-group RCT that aims to investigate the outcomes of DTTC in children with CAS and determine whether dose frequency impacts response to treatment.
| Arm | Type | Receives |
|---|---|---|
| High Dose Frequency | Experimental | Behavioral: Dynamic Temporal and Tactile Cueing TreatmentThis group will receive treatment 4x/week for 6 weeks |
| Low Dose Frequency | Active comparator | Behavioral: Dynamic Temporal and Tactile Cueing TreatmentThis group will receive treatment 2x/week for 12 weeks |
Who may qualify
- Ages
- 30 months to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- CAS diagnosis confirmed by research team as described below (e.g., Iuzzini-Seigel et al., 2022; Shriberg et al., 2017; Strand \& McCauley, 2019),
- 2;6-7;11 years of age at treatment commencement;
- English as the primary language;
Key exclusion criteria (9 listed)
- concomitant developmental disorders (including autism, global developmental delay, intellectual disability);
- diagnosis of severe or primary dysarthria as described below;
- palatal or structural orofacial anomalies as described below,
- uncorrected vision impairment
- hearing loss;
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 |
|---|---|---|
| Dynamic Temporal and Tactile Cueing TreatmentAlso: DTTCDTTC is a dynamic, motor-based treatment approach designed for children with severe CAS. This approach is based on Integral Stimulation (Edeal \& Gildersleeve-Neumann, 2011; Maas \& Farinella, 2012; Maas et al., 2019; Strand \& Debertine, 2000; Strand \& Skinder, 1999), in which the clinician instructs the child to "listen to me, watch me, and do what I do" and systematically taxes and supports the speech motor system to facilitate system-wide change in speech output (Strand, 2020). | Behavioural | High Dose Frequency, Low Dose Frequency |
Primary outcome
Changes to whole word accuracy
Time frame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
A multi-factor whole word accuracy measure (Multilevel word Accuracy Composite Scale; Case et al., under review) that systematically accounts for segmental and prosodic accuracy, word shape maintenance, and smoothness and fluency of movement transitions will be calculated on treated and similar untreated words in the generalization probe.
3 secondary outcomes
Phoneme accuracy
Time frame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
Speech Intelligibility
Time frame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post completion of treatment)
Functional communication
Time frame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- BackgroundWiig, E. H., Secord, W. A., & Semel, E. M. (2020). Clinical Evaluation of Language Fundamentals - Preschool (3rd ed.). Pearson.
- Results publication: PubMed 31846588Strand EA. Dynamic Temporal and Tactile Cueing: A Treatment Strategy for Childhood Apraxia of Speech. Am J Speech Lang Pathol. 2020 Feb 7;29(1):30-48. doi: 10.1044/2019_AJSLP-19-0005. Epub 2019 Dec 17.
- Results publication: PubMed 25313348Maas E, Gildersleeve-Neumann C, Jakielski KJ, Stoeckel R. Motor-based intervention protocols in treatment of childhood apraxia of speech (CAS). Curr Dev Disord Rep. 2014 Sep;1(3):197-206. doi: 10.1007/s40474-014-0016-4.
- Results publication: PubMed 21330650Edeal DM, Gildersleeve-Neumann CE. The importance of production frequency in therapy for childhood apraxia of speech. Am J Speech Lang Pathol. 2011 May;20(2):95-110. doi: 10.1044/1058-0360(2011/09-0005). Epub 2011 Feb 17.
- Results publication: PubMed 22207698Maas E, Farinella KA. Random versus blocked practice in treatment for childhood apraxia of speech. J Speech Lang Hear Res. 2012 Apr;55(2):561-78. doi: 10.1044/1092-4388(2011/11-0120). Epub 2011 Dec 29.
- Results publication: PubMed 31425660Maas E, Gildersleeve-Neumann C, Jakielski K, Kovacs N, Stoeckel R, Vradelis H, Welsh M. Bang for Your Buck: A Single-Case Experimental Design Study of Practice Amount and Distribution in Treatment for Childhood Apraxia of Speech. J Speech Lang Hear Res. 2019 Sep 20;62(9):3160-3182. doi: 10.1044/2019_JSLHR-S-18-0212. Epub 2019 Aug 19.
- Results publication: PubMed 35523425Iuzzini-Seigel J, Allison KM, Stoeckel R. A Tool for Differential Diagnosis of Childhood Apraxia of Speech and Dysarthria in Children: A Tutorial. Lang Speech Hear Serv Sch. 2022 Oct 6;53(4):926-946. doi: 10.1044/2022_LSHSS-21-00164. Epub 2022 May 6.
- Results publication: PubMed 28384695Shriberg LD, Strand EA, Fourakis M, Jakielski KJ, Hall SD, Karlsson HB, Mabie HL, McSweeny JL, Tilkens CM, Wilson DL. A Diagnostic Marker to Discriminate Childhood Apraxia of Speech From Speech Delay: Introduction. J Speech Lang Hear Res. 2017 Apr 14;60(4):S1094-S1095. doi: 10.1044/2016_JSLHR-S-16-0148.
- Results publicationGoldman, R., & Fristoe, M. (2015). Goldman-Fristoe Test of Articulation - Third Edition (GFTA-3). Pearson Assessments.
- Results publicationStrand, E. A., & Debertine, P. (2000). The efficacy of integral stimulation intervention with developmental apraxia of speech. Journal of Medical Speech-Language Pathology, 8(4), 295-300.
- Results publicationStrand, E. A., & McCauley, R. J. (2019). The Dynamic Evaluation of Motor Speech Skill (DEMSS). Brookes.
- Results publicationThomas-Stonell, N., Oddson, B., Robertson, B., Walker, J. & Rosenbaum, P. (2015). The FOCUS©-34: Focus on the Outcomes of Communication Under Six. Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON. http://www.focusoutcomemeasurement.ca
- Individual participant dataSharing planned: Yes. Deidentified individual level data will be shared.
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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.
Jenya Iuzzini-Seigel, PhD principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Temporal and Tactile Cueing Treatment in people with Childhood Apraxia of Speech, run by Marquette University at 1 site in United States.
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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes to whole word accuracy (time frame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)). 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 NCT05675306, which also lists 14 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 21 May 2025.