NeuropsychologyNCT05185635
Validating Neuropsych Tests in Spanish-speakers
A study testing Neuropsychological testing in people with Neuropsychology and Testing, run by Rehabilitation Hospital of Indiana.
Trial summary
The proposed pilot further emphasizes the need for collecting language and demographic specific norms for Spanish-speaking Latino individuals in the U.S. by developing new normative test data for this demographic population. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropsychology, Testing
- What is being tested?
- Neuropsychological testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between 18 to 80 years of age
- Have been living in the US for at least 1 year (12 continuous months)
- Identify Spanish as their primary and/or dominant language
- Have at least one year of formal education
- Be able to read and write at the time of evaluation in Spanish
- a score of ≥23 on the Mini-Mental State Examination (MMSE)
- score of ≤10 on the Patient Health Questionnaire-9 (PHQ-9)
- score of ≤10 on the generalized anxiety disorder (GAD-7)
Who cannot join
- History of neurodevelopmental disorder
- History of learning disorder
- Past or present neurologic condition
- Past or present chronic medical condition that may affect cognition (i.e. metabolic syndrome, chronic heart failure, sleep apnea)
- Past or present use of psychotropic medications that may affect cognition
- Past or present history of substance abuse or dependence
- Past or present history of psychiatric disorder
- Presence of severe sensory deficits, such as loss of hearing or vision
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validating Neuropsychological Tests Among Healthy Spanish-Speaking Adults: A Pilot Study
The proposed pilot further emphasizes the need for collecting language and demographic specific norms for Spanish-speaking Latino individuals in the U.S. by developing new normative test data for this demographic population. The study looks to contribute to minimize healthcare disparities and inaccurate test interpretations, which can have direct implications on diagnosis and treatment. This study will allow us to develop new neuropsychological test norms for predominantly Spanish-speaking adults by establishing expected cognitive performance on a battery of frequently used neuropsychological tests. As such, the current study will help fill a large gap in the literature pertaining to neuropsychological assessment of Spanish-Speakers living in the U.S., as well as produce data of clinical utility for providers working with this population. Finally, this pilot could serve as a model to eventually extend it to other non-English speaking populations in the US.
Read the detailed description
Hispanics/Latinos are now recognized as the largest and fastest growing ethnic/racial minority group in the United States (U.S.). By 2017, the Hispanic/Latino population reached nearly 60 million comprising 18% of the total U.S. population. Current projections indicate that Hispanic/Latinos will reach almost 111 million, making up 28% of the total U.S. population by 2060.
Clinical neuropsychologists must be equipped with the right tools to accurately serve the rapidly growing Hispanic/Latino population in the US. Findings from normative data studies in foreign countries emphasize the need for developing language and demographic specific norms for Spanish-speaking Hispanics in the US. This is particularly relevant given recent literature indicating that factors such as ethnicity, language, quality of education, degree of acculturation, and bilingualism can have a profound impact on neuropsychological test performance. Within participants that self-identify as primarily Spanish-speaking, language performance has been positively associated with greater Spanish vs. English language dominance and completing education outside the U.S., whereas other cognitive abilities have a negative association with the same variables.
The proposed pilot further emphasizes the need for collecting language and demographic specific norms for Spanish-speaking Latino individuals in the U.S. by developing new normative test data for this demographic population. The study looks to contribute to minimize healthcare disparities and inaccurate test interpretations, which can have direct implications on diagnosis and treatment. This study will allow us to develop new neuropsychological test norms for predominantly Spanish-speaking adults by establishing expected cognitive performance on a battery of frequently used neuropsychological tests. As such, the current study will help fill a large gap in the literature pertaining to neuropsychological assessment of Spanish-Speakers living in the U.S., as well as produce data of clinical utility for providers working with this population. Finally, this pilot could serve as a model to eventually extend it to other non-English speaking populations in the US.
- Conditions
- Neuropsychology, Testing
- Being tested
- Neuropsychological testing
- Keywords
- Spanish-speakers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingDiagnostic test
potential participants will complete the following: Mini-Mental State Examination (MMSE), Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 7- item (GAD-7) as part of the screening process. Additionally to the pre-screening instruments, participants will complete the following neuropsychological tests: Bi-dimensional Acculturation Scale, Bilingual Dominance Scale, Verbal Fluency Tests, Boston Naming Test, Symbol Digit Modalities Test, Brief Test of Attention, Who-UCLA Auditory Verbal Learning Test, Rey-Osterrieth Complex Figure, Modified Wisconsin Card Sorting Test, Stroop Color and Word Test, Trail Making Test, Word Accentuation Test, Clock Drawing Task, Bells Test, Test of Memory Malingering, and the Five Point Test.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Spanish-speakers | Experimental | Not described Receives: Diagnostic Test: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is well known cognitive screening tool that is widely used in neuropsychological clinical practice. Several reports have used this rapid test as a baseline measure to obtain reliable diagnoses when cognitive impairment is suspected. The MMSE has many benefits, particularly its rapid application and high sensitivity and specificity in relation to cognitive dysfunction.
Measured: Up to 5 months
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire is a self-administered assessment tool used to screen specifically for the presence depression.
Measured: Up to 5 months
Generalized Anxiety Disorder(GAD-7)
The Generalized Anxiety Disorder 7-item test is a useful self-report measure with strong criterion validity for identifying probable cases of GAD.
Measured: Up to 5 months
Bidimensional Acculturation Scale (BAS)
The Bidimensional Acculturation Scale is a 24-item measure that assesses an individual's level of acculturation to Hispanic culture and to non-Hispanic culture.
Measured: Up to 5 months
Gradient Bilingual Dominance Scale
The Bilingual Dominance Scale (BDS; Dunn \& Tree, 2009) is a 12 item self-report measure that can be used to quantify the language dominance of bilingual participants.
Measured: Up to 5 months
Verbal Fluency Tests
Verbal fluency tests (VFT) are commonly used measures both in clinical practice and research due to their sensitivity to brain damage. There are multiple variations of the VFT, but the two more commonly used paradigms measure letter and semantic fluency. In the letter VFT, participants are asked to produce as many words as possible that begin with a certain letter within a 60 second time limit. In the semantic VFT, participants are required to produce as many words as s/he can that belong to a category within the same 60 second timeframe.
Measured: Up to 5 months
Standard Form of the Boston Naming Test
The Boston Naming Test requires examinees to denominate 60 pictures, which are presented in order of increasing difficulty. If the participant does not spontaneously provide the correct response, the examiner provides a prompt in the form of a semantic cue or phonological cue
Measured: Up to 5 months
The Symbol Digit Modalities Test
The Symbol Digit Modalities Test is a timed measure that requires participants to convert symbols (shaped geometric figures) into numbers, as quickly as possible.
Measured: Up to 5 months
Brief Test of Attention
The Brief Test of Attention test consists of two equivalent forms that are administered consecutively (Forms N and L). In the N form, the subject hears a list of 10 series of letters and numbers that are intercalated, after which the subject must indicate how many numbers were mentioned. Subsequently, in the form L, the subjects are presented the same list series, but this time the subject must indicate how many letters were mentioned.
Measured: Up to 5 months
WHO-UCLA Auditory Verbal Learning Test (WHO-UCLA AVLT)
The WHO-UCLA Auditory Verbal Learning Test (AVLT) is a measure of verbal learning and memory that consists of 15 words selected from a standardized lexicon of 250 universally familiar concepts . The 15-item word list is repeated across five learning trials, and patients are to complete immediate recall, do an interference task, a short-delay free-recall, a 20-min delay, and then another free recall, followed by forced choice.
Measured: Up to 5 months
Rey-Osterrieth Complex Figure
The Rey-Osterrieth Complex Figure Test is a measure of visual perception, visual-spatial constructional ability, and visual memory that was developed by Swiss psychologist Andre Rey in 1941. For the purpose of the present study, the Spanish-language ROCF manual scoring guidelines will be followed (Rey, 2009).
Measured: Up to 5 months
Modified Wisconsin Card Sorting Test (M-WCST)
The Modified Wisconsin Card Sorting Test consists of four stimulus cards and 48 response cards. Each card varies in shape (cross, circle, triangle or star), color (red, blue, yellow or green), and number (one to four). The first participant's response is always considered right, and during the administration, the examiner informs him/her whether their response is correct or incorrect until the participant accurately classifies six consecutive cards in each category. Then, the examiner indicates that the rules have changed and to try to "find another rule." If the second category chosen differs from what was chosen in the first, it is considered correct. The test continues until all six categories are classified or until having used the whole card deck
Measured: Up to 5 months
Stroop Color-Word Interference Test
The Stroop Color and Word test consists of three pages, each with 100 components randomly organized into five columns. The subject has 45 seconds to read aloud, as quickly as possible, the columns from left to right. The sheet on words is formed by the words "Red," "Green," and "Blue" in black ink, and the score is the number of words read correctly. For the sheet containing only colors, there are groups of four X's ("XXXX") printed in blue, green, and red. The score is the number of elements properly named. Finally, the last list consists of the three words of the first printed page in the colors of the second, with words being incongruent with the color of the ink. The task is to name the ink color, inhibiting the reading of the word, and the score is the number of correctly named elements.
Measured: Up to 5 months
Trail Making Test
The Trail Making Test is a times measure consists of two parts: TMT-A and B. In the TMT-A the participant must draw a line, as quickly as they can, connecting 25 numbers in ascending order, which are circled and randomly distributed on a sheet of paper. The task requirements are similar for the TMT-B, except that the person alternates between numbers and letters the latter being significantly more difficult
Measured: Up to 5 months
Word Accentuation Test-Chicago (WAT-C)
The Word Accentuation Test is a reading test utilized to estimate premorbid cognitive ability among Spanish-speaking individual's ages 29-73 years.
Measured: Up to 5 months
Clock Drawing Test
The Clock Drawing Test is a measure that screens for dementia as well as for visuospatial, constructional, and visual planning difficulties. T
Measured: Up to 5 months
Bells Test
The Bells Test is used to detect visual inattention in children and adults and it consists of a 21.5 × 28 cm sheet of paper on which seven lines of 35 distractor figures (e.g., bird, key, apple, mushroom, car) and five target figures (bells) are presented.
Measured: Up to 5 months
Test of Memory Malingering (TOMM II)
The Test of Memory Malingering is a visual recognition test designed to help distinguish between bona fide and malingered memory impairments.
Measured: Up to 5 months
Five Point Test
The Five Point Test is a measure that requires production of novel designs under time constraints. Patients are asked to produce as many different figures as possible by connecting the dots within each rectangle.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2022 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropsychologyStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This project is an initial cross-sectional study of 40 Spanish-speaking subjects to generate pilot normative neuropsychological performance data that will be used in the future in grant submissions and as an initial feasibility platform for larger scale research projects.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehabilitation Hospital of Indiana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Garcia, Rehabilitation Hospital of Indiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185635
- Sponsor's protocol ID
- 11390
- Status last verified
- Dec 2021
- First submitted
- 29 Sep 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Neuropsychological Tests Among Healthy Spanish-Speaking Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT05185635
- Acronym / sponsor ID
- 11390
- Conditions
- Neuropsychology, Testing
- Keywords
- Spanish-speakers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rehabilitation Hospital of IndianaUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 11 Jan 2022 (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 proposed pilot further emphasizes the need for collecting language and demographic specific norms for Spanish-speaking Latino individuals in the U.S. by developing new normative test data for this demographic population. The study looks to contribute to minimize healthcare disparities and inaccurate test interpretations, which can have direct implications on diagnosis and treatment. This study will allow us to develop new neuropsychological test norms for predominantly Spanish-speaking adults by establishing expected cognitive performance on a battery of frequently used neuropsychological tests. As such, the current study will help fill a large gap in the literature pertaining to neuropsychological assessment of Spanish-Speakers living in the U.S., as well as produce data of clinical utility for providers working with this population. Finally, this pilot could serve as a model to eventually extend it to other non-English speaking populations in the US.
Detailed description
Hispanics/Latinos are now recognized as the largest and fastest growing ethnic/racial minority group in the United States (U.S.). By 2017, the Hispanic/Latino population reached nearly 60 million comprising 18% of the total U.S. population. Current projections indicate that Hispanic/Latinos will reach almost 111 million, making up 28% of the total U.S. population by 2060.
Clinical neuropsychologists must be equipped with the right tools to accurately serve the rapidly growing Hispanic/Latino population in the US. Findings from normative data studies in foreign countries emphasize the need for developing language and demographic specific norms for Spanish-speaking Hispanics in the US. This is particularly relevant given recent literature indicating that factors such as ethnicity, language, quality of education, degree of acculturation, and bilingualism can have a profound impact on neuropsychological test performance. Within participants that self-identify as primarily Spanish-speaking, language performance has been positively associated with greater Spanish vs. English language dominance and completing education outside the U.S., whereas other cognitive abilities have a negative association with the same variables.
The proposed pilot further emphasizes the need for collecting language and demographic specific norms for Spanish-speaking Latino individuals in the U.S. by developing new normative test data for this demographic population. The study looks to contribute to minimize healthcare disparities and inaccurate test interpretations, which can have direct implications on diagnosis and treatment. This study will allow us to develop new neuropsychological test norms for predominantly Spanish-speaking adults by establishing expected cognitive performance on a battery of frequently used neuropsychological tests. As such, the current study will help fill a large gap in the literature pertaining to neuropsychological assessment of Spanish-Speakers living in the U.S., as well as produce data of clinical utility for providers working with this population. Finally, this pilot could serve as a model to eventually extend it to other non-English speaking populations in the US.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This project is an initial cross-sectional study of 40 Spanish-speaking subjects to generate pilot normative neuropsychological performance data that will be used in the future in grant submissions and as an initial feasibility platform for larger scale research projects.
| Arm | Type | Receives |
|---|---|---|
| Healthy Spanish-speakers | Experimental | Diagnostic Test: Neuropsychological testing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be between 18 to 80 years of age
- Have been living in the US for at least 1 year (12 continuous months)
- Identify Spanish as their primary and/or dominant language
- Have at least one year of formal education
- Be able to read and write at the time of evaluation in Spanish
Key exclusion criteria (8 listed)
- History of neurodevelopmental disorder
- History of learning disorder
- Past or present neurologic condition
- Past or present chronic medical condition that may affect cognition (i.e. metabolic syndrome, chronic heart failure, sleep apnea)
- Past or present use of psychotropic medications that may affect cognition
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 |
|---|---|---|
| Neuropsychological testingpotential participants will complete the following: Mini-Mental State Examination (MMSE), Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 7- item (GAD-7) as part of the screening process. Additionally to the pre-screening instruments, participants will complete the following neuropsychological tests: Bi-dimensional Acculturation Scale, Bilingual Dominance Scale, Verbal Fluency Tests, Boston Naming Test, Symbol Digit Modalities Test, Brief Test of Attention, Who-UCLA Auditory Verbal Learning Test, Rey-Osterrieth Complex Figure, Modified Wisconsin Card Sorting Test, Stroop Color and Word Test, Trail Making Test, Word Accentuation Test, Clock Drawing Task, Bells Test, Test of Memory Malingering, and the Five Point Test. | Diagnostic test | Healthy Spanish-speakers |
Primary outcome
Mini-Mental State Examination (MMSE)
Time frame: Up to 5 months
The Mini-Mental State Examination (MMSE) is well known cognitive screening tool that is widely used in neuropsychological clinical practice. Several reports have used this rapid test as a baseline measure to obtain reliable diagnoses when cognitive impairment is suspected. The MMSE has many benefits, particularly its rapid application and high sensitivity and specificity in relation to cognitive dysfunction.
Patient Health Questionnaire (PHQ-9)
Time frame: Up to 5 months
The Patient Health Questionnaire is a self-administered assessment tool used to screen specifically for the presence depression.
Generalized Anxiety Disorder(GAD-7)
Time frame: Up to 5 months
The Generalized Anxiety Disorder 7-item test is a useful self-report measure with strong criterion validity for identifying probable cases of GAD.
Bidimensional Acculturation Scale (BAS)
Time frame: Up to 5 months
The Bidimensional Acculturation Scale is a 24-item measure that assesses an individual's level of acculturation to Hispanic culture and to non-Hispanic culture.
Gradient Bilingual Dominance Scale
Time frame: Up to 5 months
The Bilingual Dominance Scale (BDS; Dunn \& Tree, 2009) is a 12 item self-report measure that can be used to quantify the language dominance of bilingual participants.
Verbal Fluency Tests
Time frame: Up to 5 months
Verbal fluency tests (VFT) are commonly used measures both in clinical practice and research due to their sensitivity to brain damage. There are multiple variations of the VFT, but the two more commonly used paradigms measure letter and semantic fluency. In the letter VFT, participants are asked to produce as many words as possible that begin with a certain letter within a 60 second time limit. In the semantic VFT, participants are required to produce as many words as s/he can that belong to a category within the same 60 second timeframe.
Standard Form of the Boston Naming Test
Time frame: Up to 5 months
The Boston Naming Test requires examinees to denominate 60 pictures, which are presented in order of increasing difficulty. If the participant does not spontaneously provide the correct response, the examiner provides a prompt in the form of a semantic cue or phonological cue
The Symbol Digit Modalities Test
Time frame: Up to 5 months
The Symbol Digit Modalities Test is a timed measure that requires participants to convert symbols (shaped geometric figures) into numbers, as quickly as possible.
Brief Test of Attention
Time frame: Up to 5 months
The Brief Test of Attention test consists of two equivalent forms that are administered consecutively (Forms N and L). In the N form, the subject hears a list of 10 series of letters and numbers that are intercalated, after which the subject must indicate how many numbers were mentioned. Subsequently, in the form L, the subjects are presented the same list series, but this time the subject must indicate how many letters were mentioned.
WHO-UCLA Auditory Verbal Learning Test (WHO-UCLA AVLT)
Time frame: Up to 5 months
The WHO-UCLA Auditory Verbal Learning Test (AVLT) is a measure of verbal learning and memory that consists of 15 words selected from a standardized lexicon of 250 universally familiar concepts . The 15-item word list is repeated across five learning trials, and patients are to complete immediate recall, do an interference task, a short-delay free-recall, a 20-min delay, and then another free recall, followed by forced choice.
Rey-Osterrieth Complex Figure
Time frame: Up to 5 months
The Rey-Osterrieth Complex Figure Test is a measure of visual perception, visual-spatial constructional ability, and visual memory that was developed by Swiss psychologist Andre Rey in 1941. For the purpose of the present study, the Spanish-language ROCF manual scoring guidelines will be followed (Rey, 2009).
Modified Wisconsin Card Sorting Test (M-WCST)
Time frame: Up to 5 months
The Modified Wisconsin Card Sorting Test consists of four stimulus cards and 48 response cards. Each card varies in shape (cross, circle, triangle or star), color (red, blue, yellow or green), and number (one to four). The first participant's response is always considered right, and during the administration, the examiner informs him/her whether their response is correct or incorrect until the participant accurately classifies six consecutive cards in each category. Then, the examiner indicates that the rules have changed and to try to "find another rule." If the second category chosen differs from what was chosen in the first, it is considered correct. The test continues until all six categories are classified or until having used the whole card deck
Stroop Color-Word Interference Test
Time frame: Up to 5 months
The Stroop Color and Word test consists of three pages, each with 100 components randomly organized into five columns. The subject has 45 seconds to read aloud, as quickly as possible, the columns from left to right. The sheet on words is formed by the words "Red," "Green," and "Blue" in black ink, and the score is the number of words read correctly. For the sheet containing only colors, there are groups of four X's ("XXXX") printed in blue, green, and red. The score is the number of elements properly named. Finally, the last list consists of the three words of the first printed page in the colors of the second, with words being incongruent with the color of the ink. The task is to name the ink color, inhibiting the reading of the word, and the score is the number of correctly named elements.
Trail Making Test
Time frame: Up to 5 months
The Trail Making Test is a times measure consists of two parts: TMT-A and B. In the TMT-A the participant must draw a line, as quickly as they can, connecting 25 numbers in ascending order, which are circled and randomly distributed on a sheet of paper. The task requirements are similar for the TMT-B, except that the person alternates between numbers and letters the latter being significantly more difficult
Word Accentuation Test-Chicago (WAT-C)
Time frame: Up to 5 months
The Word Accentuation Test is a reading test utilized to estimate premorbid cognitive ability among Spanish-speaking individual's ages 29-73 years.
Clock Drawing Test
Time frame: Up to 5 months
The Clock Drawing Test is a measure that screens for dementia as well as for visuospatial, constructional, and visual planning difficulties. T
Bells Test
Time frame: Up to 5 months
The Bells Test is used to detect visual inattention in children and adults and it consists of a 21.5 × 28 cm sheet of paper on which seven lines of 35 distractor figures (e.g., bird, key, apple, mushroom, car) and five target figures (bells) are presented.
Test of Memory Malingering (TOMM II)
Time frame: Up to 5 months
The Test of Memory Malingering is a visual recognition test designed to help distinguish between bona fide and malingered memory impairments.
Five Point Test
Time frame: Up to 5 months
The Five Point Test is a measure that requires production of novel designs under time constraints. Patients are asked to produce as many different figures as possible by connecting the dots within each rectangle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological testing in people with Neuropsychology and Testing, run by Rehabilitation Hospital of Indiana.
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 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cori Conner, MA (3173292224, cori.conner@rhin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: Up to 5 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2022.