AnomiaNCT05152979
Effects of Verb Network Strengthening Treatment (VNeST) on Word Finding in Aphasia
A study testing Verb Network Strengthening Treatment (VNeST) in people with Anomia and Aphasia, run by Göteborg University at 1 site in Sweden.
Trial summary
Although there is evidence that speech-language therapy may improve speech in language disorders following left hemisphere stroke there is still a lack of evidence for which types of therapy are effective. Furthermore, in Sweden, as well as in several other countries, access to speech-language therapy is limited. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- Verb Network Strengthening Treatment (VNeST)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSweden
- Study dates
- 16 Jan 2022to 15 Apr 2024
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aphasia and subjective experience of word finding difficulties
- Diagnosed left-hemisphere stroke at least six months post-onset
- With correction, sufficient hearing and vision to be able to participate in training and assessment
- Primarily speaking Swedish for at least the last 15 years
Who cannot join
- Other neurological injury or disease
- Moderately or severely impaired comprehension
- Moderate-severe apraxia of speech or dysarthria which may interfere with assessment
- Participation in any other speech-language treatment during the study
- Active substance dependence
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University of Gothenburg, Västra Götalandsregionen
Gothenburg, Västra Götaland County, 40530
About this study
Official title: Effects of On-line and In-clinic Intervention With Verb Network Strengthening Treatment (VNeST) on Word Finding in Aphasia
Although there is evidence that speech-language therapy may improve speech in language disorders following left hemisphere stroke there is still a lack of evidence for which types of therapy are effective. Furthermore, in Sweden, as well as in several other countries, access to speech-language therapy is limited. The purpose of this clinical trial is to compare outcome from Verb Network Strengthening Treatment (VNeST) provided as In-Clinic therapy (I-CT) or as synchronous telepractice therapy (TP-T).
Read the detailed description
Every year thousands of persons in Sweden suffer from brain damage resulting in anomia, that is, word finding difficulties affecting their ability to talk to other people. Anomia is one of the most common and persistent symptoms of aphasia following a left hemisphere stroke, but it is also common in in progressive neurological diseases such as Parkinson's disease or multiple sclerosis (MS). There is evidence that more intensive speech language therapy may improve speech even in a chronic (> six month post stroke) phase of aphasia. However, access to the necessary amount of speech language therapy is limited due to lack of financial resources as well as to limitations to service providers in more rural areas.
It has been suggested that telepractice may increase the access to speech-language therapy for more people but there is a lack of knowledge of whether there is a difference in outcome from interventions provided as In-Clinic therapy (I-CT) or as telepractice therapy (TP-T).
Verb Network Strengthening Treatment (VNeST) is an anomia therapy focused on the production of short phrases. The participants generate thematically related verbs and nouns to strengthen the neural connections between the action (verb) and related thematic roles (agents and patients). From orally and written stimuli, the participants are asked to tell whom (subject) may do something (verb) with what (object) and then to do short expansions from this basic phrase. So far, results from single-case experimental design studies performed by Edmonds and colleagues are promising, showing generalization of outcomes to untrained items. Moreover, improvement in word finding was observed in other tasks like object and verb naming as well as sentence production and partly to connected speech.
The present project explores the effectiveness of VNeST, first in a small pilot study, then in a clinical trial including 80 participants. Participants with left hemisphere aphasia will be randomized to either an in-clinic therapy (I-CT) group or a telepractice therapy (TP-T) group and provided VNeST following the same treatment protocol based on Edmonds (2014).
Outcome measure include measures of naming ability on word- and phrase levels as well as in discourse. Measures of participant reported perceptions of functional communication and communicative participation as well as health related quality of life (PROMs) are also included.
- Being tested
- Verb Network Strengthening Treatment (VNeST)
- Medical subject headings
- Anomia, Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verb Network Strengthening Treatment (VNeST)Behavioural
Participants are presented with a verb (representing an activity, for example, driving) orally and in writing. The participants are first asked to name someone who may perform the given activity (an agent, for example, a chauffeur), then to name an object which the given activity may be performed with (a patient, for example, a limousine). Several types of semantic clues and assistance are provided if the participant is having difficulties finding adequate nouns. This procedure is repeated for three different agents and objects related to the given verb. The participants are then asked to choose one of the three phrases participants have created and expand on it by telling where, when and why the agent is performing the activity. After this the participant are given sentences (with several foils) including the activity as well as agents and patients, and are asked to indicate whether the sentences are correct or not.
| Study group | Role | What they receive |
|---|---|---|
| Telepractice treatment (TP-T) | Experimental | Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST).
Treatment will be done with a speech-language pathologist providing the therapy through an online platform. Receives: Behavioral: Verb Network Strengthening Treatment (VNeST) |
| In-clinic treatment (IC-T) | Active comparator | Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST).
Treatment will be done with a speech-language pathologist providing the therapy in person at a clinic. Receives: Behavioral: Verb Network Strengthening Treatment (VNeST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in naming ability of trained items at week 10.
Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Measured: Baseline, 10 weeks.
Change from baseline in naming ability of trained items at week 20.
Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Measured: Baseline, 20 weeks.
Secondary outcomes (12)
Change from baseline in naming ability of untrained items at week 10.
A measure of generalization of treatment effects to naming of ten untrained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Measured: Baseline, 10 weeks.
Change from baseline in naming ability of untrained items at week 20.
A measure of generalization of treatment effects to naming of ten untrained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Measured: Baseline, 20 weeks.
Change from baseline in confrontation naming of single words (objects and actions) at week 10.
The Object \& Action Naming Battery (Masterson \& Druks, 1998) is a measure of change in ability to name forty pictures consisting of simple black and white drawings of objects and actions. Possible score range: 0 (worst) to 40 (best).
Measured: Baseline, 10 weeks.
Change from baseline in confrontation naming of single words (objects and actions) at week 20.
The Object \& Action Naming Battery (Masterson \& Druks, 1998) is a measure of change in ability to name forty pictures consisting of simple black and white drawings of objects and actions. Possible score range: 0 (worst) to 40 (best).
Measured: Baseline, 20 weeks.
Change from baseline in confrontation naming of single words (objects) at week 10.
The Boston naming test (Goodglass et al, 1983) is a measure of change in ability to name sixty simple black and white drawings of objects. Possible score range 0 (worst) to 60 (best).
Measured: Baseline, 10 weeks.
Change from baseline in confrontation naming of single words (objects) week 20.
The Boston naming test (Goodglass et al, 1983) is a measure of change in ability to name sixty simple black and white drawings of objects. Possible score range 0 (worst) to 60 (best).
Measured: Baseline, 20 weeks.
Change from baseline in connected speech at week 10.
Connected speech tasks (Nicholas \& Brookshire, 1993) measures of change in ability to retrieve words in a picture description tasks, a procedural information task and in sharing personal information tasks. The speech produced in each task is analysed and number of words and adequate information units produced is calculated and related to time taken to produce the information. Higher numbers are better results.
Measured: Baseline, 10 weeks.
Change from baseline in connected speech at week 20.
Connected speech tasks (Nicholas \& Brookshire, 1993) measures of change in ability to retrieve words in a picture description tasks, a procedural information task and in sharing personal information tasks. The speech produced in each task is analysed and number of words and adequate information units produced is calculated and related to time taken to produce the information. Higher numbers are better results.
Measured: Baseline, 20 weeks.
Change from baseline in self reported communicative participation in everyday life at week 10.
The Communicative Participation Item Bank (CPIB; Baylor et al 2013) is a validated measure of change in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used. The scoring of each item will be summarized into a total score with the range 0 (worse) to 30 (best).
Measured: Baseline, 10 weeks.
Change from baseline in self reported communicative participation in everyday life at week 20.
The Communicative Participation Item Bank (CPIB; Baylor et al 2013) is a validated measure of change in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used. The scoring of each item will be summarized into a total score with the range 0 (worse) to 30 (best).
Measured: Baseline, 20 weeks.
Change from baseline in self reported quality of life at week 10.
The Stroke Aphasia Quality of Life (SAQOL-39, Hilari et al 2009) is a validated measure of change in participant reported health related quality of life in a questionnaire with 39 items where participants evaluate of their everyday functioning in three domains: physical, psychosocial and communication. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score. Possible score range is 1 (worse) to 5 (best).
Measured: Baseline, 10 weeks.
Change from baseline in self reported quality of life at week 20.
The Stroke Aphasia Quality of Life (SAQOL-39, Hilari et al 2009) is a validated measure of change in participant reported health related quality of life in a questionnaire with 39 items where participants evaluate of their everyday functioning in three domains: physical, psychosocial and communication. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score. Possible score range is 1 (worse) to 5 (best).
Measured: Baseline, 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start16 Jan 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Why it stopped: After a pre study including two participants in a Single Case Research Design it was concluded that that the study design, needed to be slightly revised. A new registration has been submitted to the Clinical Trials, describing the new study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnomiaStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Charlotta Saldert, Prof, Principal investigator, Inst of Neurosci & Physiology, Speech & Language Pathology Unit, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152979
- Sponsor's protocol ID
- 2019-02465
- Other IDs
- 2019
- Status last verified
- Jun 2024
- First submitted
- 18 Oct 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baylor C, Yorkston K, Eadie T, Kim J, Chung H, Amtmann D. The Communicative Participation Item Bank (CPIB): item bank calibration and development of a disorder-generic short form. J Speech Lang Hear Res. 2013 Aug;56(4):1190-208. doi: 10.1044/1092-4388(2012/12-0140). Epub 2013 Jul 1.
PubMed 23816661Edmonds LA. Tutorial for Verb Network Strengthening Treatment (VNeST): Detailed Description of the Treatment Protocol with Corresponding Theoretical Rationale. Perspectives on Neurophysiology & Neurogenic Speech & Language Disorders. 2014; 24(3): 78-88
Goodglass H, Kaplan E, Weintraub S. Boston Naming Test. Philadelphia, PA: Lea & Febiger. 1983.
Hilari K, Lamping DL, Smith SC, Northcott S, Lamb A, Marshall J. Psychometric properties of the Stroke and Aphasia Quality of Life Scale (SAQOL-39) in a generic stroke population. Clin Rehabil. 2009 Jun;23(6):544-57. doi: 10.1177/0269215508101729. Epub 2009 May 15.
PubMed 19447841Long A, Hesketh A, Paszek G, Booth M, Bowen A. Development of a reliable self-report outcome measure for pragmatic trials of communication therapy following stroke: the Communication Outcome after Stroke (COAST) scale. Clin Rehabil. 2008 Dec;22(12):1083-94. doi: 10.1177/0269215508090091.
PubMed 19052247Masterson J, Druks J. Description of a set of 164 nouns and 102 verbs matched for printed word frequency, familiarity and age-of-acquisition. Journal of Neurolinguistics. 1998; 11: 331-54.
Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.
PubMed 8487525
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of On-line and In-clinic Intervention With Verb Network Strengthening Treatment (VNeST) on Word Finding in Aphasia
- ClinicalTrials.gov ID
- NCT05152979
- Acronym / sponsor ID
- 2019-02465
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After a pre study including two participants in a Single Case Research Design it was concluded that that the study design, needed to be slightly revised. A new registration has been submitted to the Clinical Trials, describing the new study design.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 10 Dec 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.
Although there is evidence that speech-language therapy may improve speech in language disorders following left hemisphere stroke there is still a lack of evidence for which types of therapy are effective. Furthermore, in Sweden, as well as in several other countries, access to speech-language therapy is limited. The purpose of this clinical trial is to compare outcome from Verb Network Strengthening Treatment (VNeST) provided as In-Clinic therapy (I-CT) or as synchronous telepractice therapy (TP-T).
Detailed description
Every year thousands of persons in Sweden suffer from brain damage resulting in anomia, that is, word finding difficulties affecting their ability to talk to other people. Anomia is one of the most common and persistent symptoms of aphasia following a left hemisphere stroke, but it is also common in in progressive neurological diseases such as Parkinson's disease or multiple sclerosis (MS). There is evidence that more intensive speech language therapy may improve speech even in a chronic (> six month post stroke) phase of aphasia. However, access to the necessary amount of speech language therapy is limited due to lack of financial resources as well as to limitations to service providers in more rural areas.
It has been suggested that telepractice may increase the access to speech-language therapy for more people but there is a lack of knowledge of whether there is a difference in outcome from interventions provided as In-Clinic therapy (I-CT) or as telepractice therapy (TP-T).
Verb Network Strengthening Treatment (VNeST) is an anomia therapy focused on the production of short phrases. The participants generate thematically related verbs and nouns to strengthen the neural connections between the action (verb) and related thematic roles (agents and patients). From orally and written stimuli, the participants are asked to tell whom (subject) may do something (verb) with what (object) and then to do short expansions from this basic phrase. So far, results from single-case experimental design studies performed by Edmonds and colleagues are promising, showing generalization of outcomes to untrained items. Moreover, improvement in word finding was observed in other tasks like object and verb naming as well as sentence production and partly to connected speech.
The present project explores the effectiveness of VNeST, first in a small pilot study, then in a clinical trial including 80 participants. Participants with left hemisphere aphasia will be randomized to either an in-clinic therapy (I-CT) group or a telepractice therapy (TP-T) group and provided VNeST following the same treatment protocol based on Edmonds (2014).
Outcome measure include measures of naming ability on word- and phrase levels as well as in discourse. Measures of participant reported perceptions of functional communication and communicative participation as well as health related quality of life (PROMs) are also included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Telepractice treatment (TP-T) | Experimental | Behavioral: Verb Network Strengthening Treatment (VNeST)Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST). Treatment will be done with a speech-language pathologist providing the therapy through an online platform. |
| In-clinic treatment (IC-T) | Active comparator | Behavioral: Verb Network Strengthening Treatment (VNeST)Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST). Treatment will be done with a speech-language pathologist providing the therapy in person at a clinic. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aphasia and subjective experience of word finding difficulties
- Diagnosed left-hemisphere stroke at least six months post-onset
- With correction, sufficient hearing and vision to be able to participate in training and assessment
- Primarily speaking Swedish for at least the last 15 years
Key exclusion criteria (5 listed)
- Other neurological injury or disease
- Moderately or severely impaired comprehension
- Moderate-severe apraxia of speech or dysarthria which may interfere with assessment
- Participation in any other speech-language treatment during the study
- Active substance dependence
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 |
|---|---|---|
| Verb Network Strengthening Treatment (VNeST)Participants are presented with a verb (representing an activity, for example, driving) orally and in writing. The participants are first asked to name someone who may perform the given activity (an agent, for example, a chauffeur), then to name an object which the given activity may be performed with (a patient, for example, a limousine). Several types of semantic clues and assistance are provided if the participant is having difficulties finding adequate nouns. This procedure is repeated for three different agents and objects related to the given verb. The participants are then asked to choose one of the three phrases participants have created and expand on it by telling where, when and why the agent is performing the activity. After this the participant are given sentences (with several foils) including the activity as well as agents and patients, and are asked to indicate whether the sentences are correct or not. | Behavioural | In-clinic treatment (IC-T), Telepractice treatment (TP-T) |
Primary outcome
Change from baseline in naming ability of trained items at week 10.
Time frame: Baseline, 10 weeks.
Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Change from baseline in naming ability of trained items at week 20.
Time frame: Baseline, 20 weeks.
Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
12 secondary outcomes
Change from baseline in naming ability of untrained items at week 10.
Time frame: Baseline, 10 weeks.
Change from baseline in naming ability of untrained items at week 20.
Time frame: Baseline, 20 weeks.
Change from baseline in confrontation naming of single words (objects and actions) at week 10.
Time frame: Baseline, 10 weeks.
Change from baseline in confrontation naming of single words (objects and actions) at week 20.
Time frame: Baseline, 20 weeks.
Change from baseline in confrontation naming of single words (objects) at week 10.
Time frame: Baseline, 10 weeks.
Change from baseline in confrontation naming of single words (objects) week 20.
Time frame: Baseline, 20 weeks.
Change from baseline in connected speech at week 10.
Time frame: Baseline, 10 weeks.
Change from baseline in connected speech at week 20.
Time frame: Baseline, 20 weeks.
Change from baseline in self reported communicative participation in everyday life at week 10.
Time frame: Baseline, 10 weeks.
Change from baseline in self reported communicative participation in everyday life at week 20.
Time frame: Baseline, 20 weeks.
Change from baseline in self reported quality of life at week 10.
Time frame: Baseline, 10 weeks.
Change from baseline in self reported quality of life at week 20.
Time frame: Baseline, 20 weeks.
Results and safety
The study was stopped early (reason given: After a pre study including two participants in a Single Case Research Design it was concluded that that the study design, needed to be slightly revised. A new registration has been submitted to the Clinical Trials, describing the new study design.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Background: PubMed 23816661Baylor C, Yorkston K, Eadie T, Kim J, Chung H, Amtmann D. The Communicative Participation Item Bank (CPIB): item bank calibration and development of a disorder-generic short form. J Speech Lang Hear Res. 2013 Aug;56(4):1190-208. doi: 10.1044/1092-4388(2012/12-0140). Epub 2013 Jul 1.
- BackgroundEdmonds LA. Tutorial for Verb Network Strengthening Treatment (VNeST): Detailed Description of the Treatment Protocol with Corresponding Theoretical Rationale. Perspectives on Neurophysiology & Neurogenic Speech & Language Disorders. 2014; 24(3): 78-88
- BackgroundGoodglass H, Kaplan E, Weintraub S. Boston Naming Test. Philadelphia, PA: Lea & Febiger. 1983.
- Background: PubMed 19447841Hilari K, Lamping DL, Smith SC, Northcott S, Lamb A, Marshall J. Psychometric properties of the Stroke and Aphasia Quality of Life Scale (SAQOL-39) in a generic stroke population. Clin Rehabil. 2009 Jun;23(6):544-57. doi: 10.1177/0269215508101729. Epub 2009 May 15.
- Background: PubMed 19052247Long A, Hesketh A, Paszek G, Booth M, Bowen A. Development of a reliable self-report outcome measure for pragmatic trials of communication therapy following stroke: the Communication Outcome after Stroke (COAST) scale. Clin Rehabil. 2008 Dec;22(12):1083-94. doi: 10.1177/0269215508090091.
- BackgroundMasterson J, Druks J. Description of a set of 164 nouns and 102 verbs matched for printed word frequency, familiarity and age-of-acquisition. Journal of Neurolinguistics. 1998; 11: 331-54.
- Background: PubMed 8487525Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.
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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.
Charlotta Saldert, Prof principal investigator
Inst of Neurosci & Physiology, Speech & Language Pathology Unit, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verb Network Strengthening Treatment (VNeST) in people with Anomia and Aphasia, run by Göteborg University at 1 site in Sweden.
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 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: stopped early, as of the sponsor's last update on 24 Jun 2024. 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 Sweden. 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 was stopped early (reason given: After a pre study including two participants in a Single Case Research Design it was concluded that that the study design, needed to be slightly revised. A new registration has been submitted to the Clinical Trials, describing the new study design.). Results are not available in the source record.
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 from baseline in naming ability of trained items at week 10. (time frame: Baseline, 10 weeks.). The study lists 2 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 NCT05152979, which also lists 7 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 24 Jun 2024.