Broca's AphasiaNCT02928822
Virtual Reality Based Sensorimotor Speech Therapy
A study testing VR-based sensorimotor aphasia therapy in people with Broca's Aphasia, run by Universitat Pompeu Fabra at 2 sites in Spain.
Trial summary
The purpose of this study is to determine whether VR based language rehabilitation scenario based on the core premises of ILAT has a beneficial effect on the linguistic performance (faster retrieval of the target lexicon and general fluency) of Broca's aphasia patients. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Broca's Aphasia
- What is being tested?
- VR-based sensorimotor aphasia therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesSpain
- Study dates
- Jul 2016to Apr 2018
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Broca's aphasia patient following ischemic and hemorrhagic strokes (moderate and chronic stages).
- Mild, moderate and chronic Broca's stages.
- Age: between 25 and 85 years old.
- Absence of any major cognitive impairments (MMSE>25).
Who cannot join
- Presence of major perceptual, motor and neuropsychological impairments that make it difficult to interact with the system, including severe forms of motor impairments and apraxia, visual processing deficits, planning deficits, learning deficits, memory deficits, or attentional deficits.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universitat Pompeu Fabra, Laboratory of Synthetic Perceptive, Emotive and Cognitive Systems (SPECS)
Barcelona, 08018
Clínica de l'Hospital Universatari Joan XXIII de Tarragona
Tarragona, 43005
About this study
Official title: Terapia de Lenguaje, Sensorial y Motora, Basada en Realidad Virtual
The purpose of this study is to determine whether VR based language rehabilitation scenario based on the core premises of ILAT has a beneficial effect on the linguistic performance (faster retrieval of the target lexicon and general fluency) of Broca's aphasia patients. Furthermore, it aims at testing the effects of cueing (visual and auditory) on word retrieval.
Read the detailed description
Acquired brain lesions such as stroke often result the most common disabling neurological damages (Carter et al, 2012). 35-40% of stroke patients suffer serious language deficits and patients are frequently left with chronic disabilities which adversely impact their quality of life. Thus, the need for efficient rehabilitation methods increases. Recent studies show that Broca's area and the premotor cortex are anatomically coupled (Pulvermuller 2005) suggesting that for a therapy to be effective, in the brain there must be an interaction between linguistic neural system, motor and sensory circuits, memory, planning and monitoring (Kurland et al, 2012). These hypotheses led to the establishment of the so-called Intensive Language-Action Therapy (ILAT) (Pulvermuller 2012) which promotes motor movement during language practice. Thus, ILAT is an action-embedded language therapy grounded in three main principles: intense practice, overcoming learned non-use, and promoting motor actions (no compensations). Recently, a number of studies examined the functionality of virtual reality based rehabilitation systems that aim at post stroke motor recovery of upper extremities (Boian et al., 2002; Cameirão, Badia, Oller, \& Verschure, 2010; Jack et al., 2001; Saposnik et al., 2010). In the present study, the goal is to further validate VR based language rehabilitation system based on the core principles of ILAT implemented within the environment of the rehabilitation Gaming System (RGS). Additionally, the goal is to investigate the effects of cueing on word retrieval. It was shown that conduction and Broca's aphasics exhibit the highest responsiveness to cueing (Li \& Williams 1989). In order to overcome subsequent disturbances in word retrieval mechanisms, a number of cueing methods have been established to improve both the immediate and long term lexical access (Howard 2000). Both semantic and phonemic cues act as primes and are usually administered by the therapist in a written or oral manner containing phonological, semantic or syntactic information about the target word (Howard et al. 1985, Howard2000). Here, the investigators will implement the system with videos representing the lip motion representative for a correct pronunciation of the target words, as well as a representative sound (i.e. barking sound in case of dog). The investigators expect that the proposed system will be efficient in treating post stroke chronic Broca's aphasia patients according to the standard scales such as Boston Naming Test and Communicative Activity Log.
- Conditions
- Broca's Aphasia
- Being tested
- VR-based sensorimotor aphasia therapy, Control Group (conventional aphasia rehabilitation)
- Keywords
- stroke, broca's aphasia, priming, Intensive language-action therapy, Rehabilitation gaming system
- Medical subject headings
- Aphasia, Broca, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based sensorimotor aphasia therapyBehavioural
VR-based sensorimotor aphasia therapy. 8 weeks, 1 session a week, 30min-1h per session of language and motor therapy using using VR rehabilitation gaming system. The patients will play in pairs.
Control Group (conventional aphasia rehabilitation)Behavioural
8 weeks, 1 session a week, 30min-1h per session of conventional aphasia rehabilitation training the same vocabulary as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Virtual reality based sensorimotor aphasia therapy. Receives: Behavioral: VR-based sensorimotor aphasia therapy |
| Control Group | Active comparator | Conventional aphasia therapy. Receives: Behavioral: Control Group (conventional aphasia rehabilitation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in linguistic performance and competence measured using abbreviated version of Boston Naming Test
Measured: Change from the baseline outcome (date of randomization) of the abbreviated version of Boston Naming Test at 16-weeks (follow up).
Secondary outcomes (3)
The upper extremity Fugl-Meyer Assessment
Measured: Change from the baseline outcome (date of randomization) of the The upper extremity Fugl-Meyer Assessment at week 4, 8 and 16 (follow up).
Measure of language use during daily leaving activities using Communication Activity Log
Measured: Change from the baseline outcome (date of randomization) of the Communication Activity Log assesed by the patient, a blinded therapist and a caregiver at week 4, 8 and 16 (follow up).
The measure of learning using Vocabulary Test
Measured: Measured five times over the period of the intervention (at randomization, at week 2, at week 4, at week 6, at week 8) and once at the followed up period at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Broca's AphasiaStudies 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, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona.
- Responsible party
- Principal investigator, Paul Verschure, Universitat Pompeu Fabra
- Investigators
- Rosa Maria San Segundo Mozo, Dra., Principal investigator, Laboratory of Synthetic Perceptive, Emotive and Cognitive SystemsRosa Maria San Segundo Mmozo, Dra., Study director, Servicio de Medicina Fisica i Rehabilitacion de Joan XXII de Tarragona. 977295801
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928822
- Sponsor's protocol ID
- SANARaphasia2016/2017
- Status last verified
- Jul 2018
- First submitted
- 30 Jul 2016
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Carter AR, Shulman GL, Corbetta M. Why use a connectivity-based approach to study stroke and recovery of function? Neuroimage. 2012 Oct 1;62(4):2271-80. doi: 10.1016/j.neuroimage.2012.02.070. Epub 2012 Mar 5.
PubMed 22414990MacGregor LJ, Difrancesco S, Pulvermuller F, Shtyrov Y, Mohr B. Ultra-rapid access to words in chronic aphasia: the effects of intensive language action therapy (ILAT). Brain Topogr. 2015 Mar;28(2):279-91. doi: 10.1007/s10548-014-0398-y. Epub 2014 Nov 18.
PubMed 25403745Pulvermuller F. Brain mechanisms linking language and action. Nat Rev Neurosci. 2005 Jul;6(7):576-82. doi: 10.1038/nrn1706.
PubMed 15959465Kurland J, Pulvermuller F, Silva N, Burke K, Andrianopoulos M. Constrained versus unconstrained intensive language therapy in two individuals with chronic, moderate-to-severe aphasia and apraxia of speech: behavioral and fMRI outcomes. Am J Speech Lang Pathol. 2012 May;21(2):S65-87. doi: 10.1044/1058-0360(2012/11-0113). Epub 2012 Jan 31.
PubMed 22294409Boian R, Sharma A, Han C, Merians A, Burdea G, Adamovich S, Recce M, Tremaine M, Poizner H. Virtual reality-based post-stroke hand rehabilitation. Stud Health Technol Inform. 2002;85:64-70.
PubMed 15458061Cameirao MS, Badia SB, Oller ED, Verschure PF. Neurorehabilitation using the virtual reality based Rehabilitation Gaming System: methodology, design, psychometrics, usability and validation. J Neuroeng Rehabil. 2010 Sep 22;7:48. doi: 10.1186/1743-0003-7-48.
PubMed 20860808Jack D, Boian R, Merians AS, Tremaine M, Burdea GC, Adamovich SV, Recce M, Poizner H. Virtual reality-enhanced stroke rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2001 Sep;9(3):308-18. doi: 10.1109/7333.948460.
PubMed 11561668Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.
PubMed 20508185Routhier S, Bier N, Macoir J. The contrast between cueing and/or observation in therapy for verb retrieval in post-stroke aphasia. J Commun Disord. 2015 Mar-Apr;54:43-55. doi: 10.1016/j.jcomdis.2015.01.003. Epub 2015 Jan 21.
PubMed 25638465Abel S, Weiller C, Huber W, Willmes K, Specht K. Therapy-induced brain reorganization patterns in aphasia. Brain. 2015 Apr;138(Pt 4):1097-112. doi: 10.1093/brain/awv022. Epub 2015 Feb 15.
PubMed 25688082Grechuta K, Rubio Ballester B, Espin Munne R, Usabiaga Bernal T, Molina Hervas B, Mohr B, Pulvermuller F, San Segundo RM, Verschure PFMJ. Multisensory cueing facilitates naming in aphasia. J Neuroeng Rehabil. 2020 Sep 9;17(1):122. doi: 10.1186/s12984-020-00751-w.
PubMed 32907594Grechuta K, Rubio Ballester B, Espin Munne R, Usabiaga Bernal T, Molina Hervas B, Mohr B, Pulvermuller F, San Segundo R, Verschure P. Augmented Dyadic Therapy Boosts Recovery of Language Function in Patients With Nonfluent Aphasia. Stroke. 2019 May;50(5):1270-1274. doi: 10.1161/STROKEAHA.118.023729.
PubMed 30913976
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terapia de Lenguaje, Sensorial y Motora, Basada en Realidad Virtual
- ClinicalTrials.gov ID
- NCT02928822
- Acronym / sponsor ID
- SANARaphasia2016/2017
- Conditions
- Broca's Aphasia
- Keywords
- stroke, broca's aphasia, priming, Intensive language-action therapy, Rehabilitation gaming system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona.
- Study start
- Jul 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 Oct 2016 (estimated)
- 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 purpose of this study is to determine whether VR based language rehabilitation scenario based on the core premises of ILAT has a beneficial effect on the linguistic performance (faster retrieval of the target lexicon and general fluency) of Broca's aphasia patients. Furthermore, it aims at testing the effects of cueing (visual and auditory) on word retrieval.
Detailed description
Acquired brain lesions such as stroke often result the most common disabling neurological damages (Carter et al, 2012). 35-40% of stroke patients suffer serious language deficits and patients are frequently left with chronic disabilities which adversely impact their quality of life. Thus, the need for efficient rehabilitation methods increases. Recent studies show that Broca's area and the premotor cortex are anatomically coupled (Pulvermuller 2005) suggesting that for a therapy to be effective, in the brain there must be an interaction between linguistic neural system, motor and sensory circuits, memory, planning and monitoring (Kurland et al, 2012). These hypotheses led to the establishment of the so-called Intensive Language-Action Therapy (ILAT) (Pulvermuller 2012) which promotes motor movement during language practice. Thus, ILAT is an action-embedded language therapy grounded in three main principles: intense practice, overcoming learned non-use, and promoting motor actions (no compensations). Recently, a number of studies examined the functionality of virtual reality based rehabilitation systems that aim at post stroke motor recovery of upper extremities (Boian et al., 2002; Cameirão, Badia, Oller, \& Verschure, 2010; Jack et al., 2001; Saposnik et al., 2010). In the present study, the goal is to further validate VR based language rehabilitation system based on the core principles of ILAT implemented within the environment of the rehabilitation Gaming System (RGS). Additionally, the goal is to investigate the effects of cueing on word retrieval. It was shown that conduction and Broca's aphasics exhibit the highest responsiveness to cueing (Li \& Williams 1989). In order to overcome subsequent disturbances in word retrieval mechanisms, a number of cueing methods have been established to improve both the immediate and long term lexical access (Howard 2000). Both semantic and phonemic cues act as primes and are usually administered by the therapist in a written or oral manner containing phonological, semantic or syntactic information about the target word (Howard et al. 1985, Howard2000). Here, the investigators will implement the system with videos representing the lip motion representative for a correct pronunciation of the target words, as well as a representative sound (i.e. barking sound in case of dog). The investigators expect that the proposed system will be efficient in treating post stroke chronic Broca's aphasia patients according to the standard scales such as Boston Naming Test and Communicative Activity Log.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: VR-based sensorimotor aphasia therapyVirtual reality based sensorimotor aphasia therapy. |
| Control Group | Active comparator | Behavioral: Control Group (conventional aphasia rehabilitation)Conventional aphasia therapy. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Broca's aphasia patient following ischemic and hemorrhagic strokes (moderate and chronic stages).
- Mild, moderate and chronic Broca's stages.
- Age: between 25 and 85 years old.
- Absence of any major cognitive impairments (MMSE>25).
Key exclusion criteria (1 listed)
- Presence of major perceptual, motor and neuropsychological impairments that make it difficult to interact with the system, including severe forms of motor impairments and apraxia, visual processing deficits, planning deficits, learning deficits, memory deficits, or attentional deficits.
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 |
|---|---|---|
| VR-based sensorimotor aphasia therapyVR-based sensorimotor aphasia therapy. 8 weeks, 1 session a week, 30min-1h per session of language and motor therapy using using VR rehabilitation gaming system. The patients will play in pairs. | Behavioural | Experimental Group |
| Control Group (conventional aphasia rehabilitation)8 weeks, 1 session a week, 30min-1h per session of conventional aphasia rehabilitation training the same vocabulary as the experimental group. | Behavioural | Control Group |
Primary outcome
Change in linguistic performance and competence measured using abbreviated version of Boston Naming Test
Time frame: Change from the baseline outcome (date of randomization) of the abbreviated version of Boston Naming Test at 16-weeks (follow up).
3 secondary outcomes
The upper extremity Fugl-Meyer Assessment
Time frame: Change from the baseline outcome (date of randomization) of the The upper extremity Fugl-Meyer Assessment at week 4, 8 and 16 (follow up).
Measure of language use during daily leaving activities using Communication Activity Log
Time frame: Change from the baseline outcome (date of randomization) of the Communication Activity Log assesed by the patient, a blinded therapist and a caregiver at week 4, 8 and 16 (follow up).
The measure of learning using Vocabulary Test
Time frame: Measured five times over the period of the intervention (at randomization, at week 2, at week 4, at week 6, at week 8) and once at the followed up period at week 16
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 12 Jul 2018.
- Background: PubMed 22414990Carter AR, Shulman GL, Corbetta M. Why use a connectivity-based approach to study stroke and recovery of function? Neuroimage. 2012 Oct 1;62(4):2271-80. doi: 10.1016/j.neuroimage.2012.02.070. Epub 2012 Mar 5.
- Background: PubMed 25403745MacGregor LJ, Difrancesco S, Pulvermuller F, Shtyrov Y, Mohr B. Ultra-rapid access to words in chronic aphasia: the effects of intensive language action therapy (ILAT). Brain Topogr. 2015 Mar;28(2):279-91. doi: 10.1007/s10548-014-0398-y. Epub 2014 Nov 18.
- Background: PubMed 15959465Pulvermuller F. Brain mechanisms linking language and action. Nat Rev Neurosci. 2005 Jul;6(7):576-82. doi: 10.1038/nrn1706.
- Background: PubMed 22294409Kurland J, Pulvermuller F, Silva N, Burke K, Andrianopoulos M. Constrained versus unconstrained intensive language therapy in two individuals with chronic, moderate-to-severe aphasia and apraxia of speech: behavioral and fMRI outcomes. Am J Speech Lang Pathol. 2012 May;21(2):S65-87. doi: 10.1044/1058-0360(2012/11-0113). Epub 2012 Jan 31.
- Background: PubMed 15458061Boian R, Sharma A, Han C, Merians A, Burdea G, Adamovich S, Recce M, Tremaine M, Poizner H. Virtual reality-based post-stroke hand rehabilitation. Stud Health Technol Inform. 2002;85:64-70.
- Background: PubMed 20860808Cameirao MS, Badia SB, Oller ED, Verschure PF. Neurorehabilitation using the virtual reality based Rehabilitation Gaming System: methodology, design, psychometrics, usability and validation. J Neuroeng Rehabil. 2010 Sep 22;7:48. doi: 10.1186/1743-0003-7-48.
- Background: PubMed 11561668Jack D, Boian R, Merians AS, Tremaine M, Burdea GC, Adamovich SV, Recce M, Poizner H. Virtual reality-enhanced stroke rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2001 Sep;9(3):308-18. doi: 10.1109/7333.948460.
- Background: PubMed 20508185Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.
- Background: PubMed 25638465Routhier S, Bier N, Macoir J. The contrast between cueing and/or observation in therapy for verb retrieval in post-stroke aphasia. J Commun Disord. 2015 Mar-Apr;54:43-55. doi: 10.1016/j.jcomdis.2015.01.003. Epub 2015 Jan 21.
- Background: PubMed 25688082Abel S, Weiller C, Huber W, Willmes K, Specht K. Therapy-induced brain reorganization patterns in aphasia. Brain. 2015 Apr;138(Pt 4):1097-112. doi: 10.1093/brain/awv022. Epub 2015 Feb 15.
- Derived from this study: PubMed 32907594Grechuta K, Rubio Ballester B, Espin Munne R, Usabiaga Bernal T, Molina Hervas B, Mohr B, Pulvermuller F, San Segundo RM, Verschure PFMJ. Multisensory cueing facilitates naming in aphasia. J Neuroeng Rehabil. 2020 Sep 9;17(1):122. doi: 10.1186/s12984-020-00751-w.
- Derived from this study: PubMed 30913976Grechuta K, Rubio Ballester B, Espin Munne R, Usabiaga Bernal T, Molina Hervas B, Mohr B, Pulvermuller F, San Segundo R, Verschure P. Augmented Dyadic Therapy Boosts Recovery of Language Function in Patients With Nonfluent Aphasia. Stroke. 2019 May;50(5):1270-1274. doi: 10.1161/STROKEAHA.118.023729.
- Individual participant dataSharing planned: Undecided
Related trials for Broca's Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Stroke Rehabilitation, Aphasia, Broca
Recruiting
Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
Aphasia Non Fluent, Stroke
Active, not recruiting
Mirror Speech Entrainment: A Novel Technique for Voice Personalized Speech Entrainment for Nonfluent Aphasia
Aphasia Non Fluent, Stroke
Not yet recruiting
Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity
Non-fluent Aphasia
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.
Rosa Maria San Segundo Mozo, Dra. principal investigator
Laboratory of Synthetic Perceptive, Emotive and Cognitive Systems
Rosa Maria San Segundo Mmozo, Dra. study director
Servicio de Medicina Fisica i Rehabilitacion de Joan XXII de Tarragona. 977295801
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based sensorimotor aphasia therapy in people with Broca's Aphasia, run by Universitat Pompeu Fabra at 2 sites in Spain.
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 4 inclusion and 1 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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Change in linguistic performance and competence measured using abbreviated version of Boston Naming Test (time frame: Change from the baseline outcome (date of randomization) of the abbreviated version of Boston Naming Test at 16-weeks (follow up).). 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 NCT02928822, which also lists 12 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 12 Jul 2018.