Trial Title:
Remote Neuropsychological Assessment of Patients With Neurological Disorders and Injuries
NCT ID:
NCT05819008
Condition:
Traumatic Brain Injury
Stroke
Multiple Sclerosis
Parkinson Disease
Epilepsy
Brain Tumor
Conditions: Official terms:
Parkinson Disease
Multiple Sclerosis
Brain Injuries
Brain Injuries, Traumatic
Nervous System Diseases
Wounds and Injuries
Conditions: Keywords:
Neuropsychological assessment
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Neuropsychological Assessment
Description:
To validate Mindmore Distance (MD), the following standard neuropsychological tests will
be used in a testing session with a psychologist:
- Wordlist 1 and 2 from WMS-III (Wechsler, 1997). Equivalent to RAVLT in MD
- Coding from WAIS-IV (Wechsler, 2008). Equivalent to SDPT in MD
- Block Span from WMS-III (Wechsler, 1997). Equivalent to CBT in MD
- Trail Making Test from D-KEFS (Delis et al., 2001). Equivalent to TMT-Click in MD
- Color-Word Interference Test from D-KEFS. Equivalent to Stroop in MD
- Verbal fluency from D-KEFS. Equivalent to FAS in MD
All participants will complete some questionnaires: Hospital Anxiety and Depression Scale
(Zigmond & Snaith, 1983); Insomnia Severity Index (Bastien, Vallieres, & Morin, 2001);
Cognitive Failure Questionnaire (Broadbent, Cooper, FitzGerald, & Parkes, 1982);
Perceived Stress Scale (Levenstein et al., 1993); Multidimensional Fatigue Inventory
(Smets, Garssen, Bonke, & De Haes, 1995).
Arm group label:
Patients with neurological disorders or injuries and Healthy Controls
Summary:
For the last decades, many aspects of human life have been altered by digital technology.
For health care, this have opened a possibility for patients who have difficulties
travelling a long distance to a hospital to meet with their health care providers over
different digital platforms. With an increased digital literacy, and an aging population
often living in the countryside, far from hospitals or other health care settings, an
increasing need for digitalization of meetings between patients and health care personnel
is inevitable.
However, neuropsychological assessment is one sort of health care not possible to
directly transfer into digital form. These evaluations are most often performed with well
validated tests, only to be used in a paper-pencil form with a specially trained
psychologist during physical meetings.
The aim of this project is to investigate whether a newly developed digital
neuropsychological test battery can be used to perform remote assessments of cognitive
function in patients with neurological injuries and impairments. To this date, there are
no such test batteries available in the Swedish language.
Mindmore (www.mindmore.com) is a test system developed in Sweden, performing
neuropsychological tests on a tablet, but still with the psychologist present in the
room. This system is now evolving into offering the possibility for the patient to
perform the test in their own home, using their own computer or tablet. The aim of the
present research project is to validate this latter system (Mindmore Distance), using the
following research questions:
1. Are the tests in Mindmore Distance equivalent to traditional neuropsychological
tests in patients with traumatic brain injury, stroke, multiple sclerosis,
Parkinson's Disease, epilepsy, and brain tumor?
2. Can the results from Mindmore Distance be transferred into neuropsychological
profiles that can be used in diagnostics for specific patient groups?
3. How do the patients experience undergoing a neuropsychological evaluation on their
own compared to traditional neuropsychological assessment in a physical meeting with
a psychologist?
Detailed description:
The neurological disorders and injuries are characterized by damage to neurons in the
central nervous system. Since many of these damages affect the brain, rudimentary
functions of the brain, including cognition, are often affected in these patient groups
which include traumatic brain injuries, stroke, multiple sclerosis, Parkinson's Disease,
epilepsy and different forms of brain tumors.
Neuropsychological assessment of cognitive functions plays a central role in both
diagnostics and evaluation as well as planning of treatment and rehabilitation for these
patients. Today, the neuropsychological evaluation is often used as an objective way of
determining cognitive dysfunction that can be used for medical statements about ability
to work, or to establish level of functioning in insurance cases.
Traditional neuropsychological assessment is performed in a physical meeting between the
patient and a psychologist in charge of the examination, where different cognitive
functions are assessed. For example, the psychologist can read out loud words or numbers
to be remembered by the patient (working and long-term memory), the patient might search
for a specific target on a piece of paper (attention or mental speed), or that the
patient is instructed to say as many words as possible starting with a specific letter
(verbal fluency and executive functions). The same function is often tested with
different tests to validate the results, and the results are interpreted in the light of
the patient's behavior and amnestic information. After the testing session, the
psychologist is faced with an often time-demanding task of scoring and comparing the
results to normative data. Since the start of the new millennium, computer-based tests or
a combination of computers and "paper-pencil tests" of tablets have become more common in
clinical use. These have reduced some the time that the psychologist has to spend on
scoring, but still mean that the patient has to come to the clinic to undergo the
neuropsychological examination.
During the corona pandemic, many health care visits were cancelled, when many patients,
especially in the older population, had to minimize the risk of infection. In Sweden, a
large and sparsely populated country, another challenge to physical meetings in health
care is long and demanding travels for patients. Thus, many visits to health care, both
before and during the pandemic, has be transferred to digital form and online platforms.
Neuropsychological evaluations are however not directly transferable into digital form.
Both reliability and validity of the neuropsychological assessment are highly reliant on
standardization of instructions and administration procedures. Since the results from the
tests are compared to the results of a normal population, where the standardized
administration procedure has been used, it is very important that the testing with
patients are performed in the same way. If the administration procedure is changed too
much, the results will not be reliable nor valid. Systematic reviews and meta analyses
have shown that some verbal tests may be possible to perform in a video conference
meeting, but for tests involving motor or visual processing, this cannot be recommended.
Thus, there is a need for the development of instruments that can enable psychologists to
perform neuropsychological evaluations remotely, where both administration and scoring
are performed automatically, saving cost and time for the health care system. Mindmore
(www.mindmore.com) is a digital neuropsychological test battery developed in Sweden and
it has been validated in a Swedish healthy population, and normative data has been
collected. Included in this battery are tests of audioverbal learning and episodic
memory, mental speed, working memory and executive functions in the form of inhibition,
shifting and verbal fluency. However, this system still requires a visit to health care
where the testing is performed. Now, Mindmore is launching a self-administered desktop
version of this battery, Mindmore Distance, which can be performed on any computer or
tablet with an internet connection. This is the first Swedish test on the market able to
perform neuropsychological tests remotely. It is very important that neuropsychological
tests are developed, validated and normed in the countries where they will be used
clinically, since language, culture and education affect results on these tests at a very
high degree. Mindmore Distance is right now being validated and normed in a healthy
Swedish population, but no study has been performed on patients. Validating test in
specific patient groups is critical since this can answer whether the tests are suitable
for the patients and to see if the tests are possible to use to discriminate between
different patient groups or between patients and healthy controls.
In a cross-sectional design, patients with neurological disorders or injuries will be
tested using Mindmore Distance at home, and traditional neuropsychological test with a
neuropsychologist at Neuro-Head-Neck-Centre (NHHC) at the Umeå University Hospital, Umeå,
Sweden. Patient groups included are: Traumatic brain injury (TBI), Stroke, Multiple
sclerosis, Parkinson's Disease, Epilepsy and Brain Tumors.
When referred to neuropsychological examination at NHHC, patients will receive written
information about the project and contact information to the principal investigator to
whom they can turn for questions. If they wish to participate, a link in the letter will
take them to the research person information, where they can sign informed consent using
Scrive e-sign (scrive.com) and digital identification (BankID). After this, patients will
be randomized to performing standard neuropsychological assessment at the clinic or
Mindmore Distance at home first. This randomization procedure is used to control for
test-retest or learning effects.
Healthy controls will be recruited through advertising, where they through a link will
reach the same page as patients. After signing informed consent, a similar randomization
procedure as for patients will take place. Healthy controls will perform the physical
neuropsychological examination at a specific occasion in the facilities of the Department
of Psychology, Umeå University. In the same session as the traditional neuropsychological
evaluation, both patients and healthy controls will complete questionnaires on
demographical and health related factors.
The validity of Mindmore test will be validated against traditional paper-pencil
neuropsychological test using Pearson and/or Spearman correlation coefficients,
interpreted using Cohens (1992) cutoffs of weak (0.1), medium (0.3) and strong (0.5)
correlations. Further, multiple linear regressions will be performed to investigate and
adjust for background variables.
Criteria for eligibility:
Study pop:
Outpatients treated at the Neuro-Head-Neck-Center (NHHC) at Umeå University hospital.
When referred to neuropsychological examination at NHHC, patients will receive written
information about the project and contact information to the principal investigator to
whom they can turn for questions, before signing informed consent.
Patient groups included are:
- Traumatic brain injury (TBI), including patients with persisting symptoms after
concussion, post-concussional disorder.
- Stroke
- Multiple sclerosis
- Parkinson's Disease
- Epilepsy
- Brain Tumors
A comparison group of healthy volunteers will be recruited using advertising.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- age 18 and above
- Diagnosed with a neurological disorder or injury, alternatively under medical
examination for such a diagnosis
- Owns and can handle a computer with internet connection
Exclusion Criteria:
- Severe psychiatric disorder, such a schizophrenia, severe depression
- Addiction of alcohol or other substances
- Not speaker of Swedish
- On sedatives, such as sleep or pain medication
- Multiple neurological diagnoses
- Not being able to participate in a neuropsychological examination, or to give
informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Umeå University Hospital
Address:
City:
Umeå
Zip:
90185
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Nils Berginström, PhD
Phone:
0730300303
Email:
nils.berginstrom@umu.se
Start date:
March 10, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Umeå University
Agency class:
Other
Collaborator:
Agency:
Västerbotten County Council, Sweden
Agency class:
Other
Source:
Umeå University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05819008
