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Traumatic Brain InjuryNCT05819008

Remote Neuropsychological Assessment of Patients With Neurological Disorders and Injuries

An observational study of Traumatic Brain Injury and Stroke, run by Umeå University at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Traumatic Brain Injury, Stroke, Multiple Sclerosis
What is being tested?
Neuropsychological Assessment
Type of treatment
Injection or infusion
How many people
350 participants
Where
1 siteSweden
Study dates
10 Mar 2023to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nils Berginström, PhD contact

+46(0)90-786 88 64

nils.berginstrom@umu.se

Sweden1 site, 1 recruiting
  • Umeå University Hospital

    Umeå, 90185

    Nils Berginström, PhD, 0730300303, nils.berginstrom@umu.se

    Recruiting

Other trials in Sweden

About this study

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.

Read more

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?
Read the 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.

Being tested
Neuropsychological Assessment
Keywords
Neuropsychological assessment
Medical subject headings
Brain Injuries, Traumatic, Stroke, Multiple Sclerosis, Parkinson Disease, Epilepsy, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuropsychological AssessmentDiagnostic test

    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).

Study groups in NCT05819008
Study groupRoleWhat they receive
Patients with neurological disorders or injuries and Healthy ControlsNot described
Receives: Diagnostic Test: Neuropsychological Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validity of Rey Auditory Verbal Learning Test in Mindmore

    The results of RAVLT in Mindmore will be validated against Word List Recall from Wechsler Memory Scale - Third edition.

    Measured: Baseline

  2. Validity of Symbol Digit Processing Test in Mindmore

    The results of SDPT in Mindmore will be validated against Coding from Wechsler Adult Intelligence Scale - Fourth edition.

    Measured: Baseline

  3. Validity of Corsi Block Test in Mindmore

    The results of CBT in Mindmore will be validated against Block Span from Wechsler Memory Scale - Third edition.

    Measured: Baseline

  4. Validity of Trail Making Test - Click in Mindmore

    The results of TMT-Click in Mindmore will be validated against Trail Making Test from Delis-Kaplan Executive Functions System.

    Measured: Baseline

  5. Validity of Stroop in Mindmore

    The results of Stroop in Mindmore will be validated against Color-Word Interference Test from Delis-Kaplan Executive Functions System.

    Measured: Baseline

  6. Validity of FAS in Mindmore

    The results of FAS in Mindmore will be validated against Verbal Fluency from Delis-Kaplan Executive Functions System.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study start10 Mar 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05819008
Sponsor's protocol ID
7004076
Status last verified
Mar 2026
First submitted
21 Mar 2023
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PubMed 11438246
  • Benedict RHB, Amato MP, DeLuca J, Geurts JJG. Cognitive impairment in multiple sclerosis: clinical management, MRI, and therapeutic avenues. Lancet Neurol. 2020 Oct;19(10):860-871. doi: 10.1016/S1474-4422(20)30277-5. Epub 2020 Sep 16.

    PubMed 32949546
  • Bjorngrim S, van den Hurk W, Betancort M, Machado A, Lindau M. Comparing Traditional and Digitized Cognitive Tests Used in Standard Clinical Evaluation - A Study of the Digital Application Minnemera. Front Psychol. 2019 Oct 18;10:2327. doi: 10.3389/fpsyg.2019.02327. eCollection 2019.

    PubMed 31681117
  • Brearly TW, Shura RD, Martindale SL, Lazowski RA, Luxton DD, Shenal BV, Rowland JA. Neuropsychological Test Administration by Videoconference: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2017 Jun;27(2):174-186. doi: 10.1007/s11065-017-9349-1. Epub 2017 Jun 16.

    PubMed 28623461
  • Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.

    PubMed 7126941
  • Buckley RF, Sparks KP, Papp KV, Dekhtyar M, Martin C, Burnham S, Sperling RA, Rentz DM. Computerized Cognitive Testing for Use in Clinical Trials: A Comparison of the NIH Toolbox and Cogstate C3 Batteries. J Prev Alzheimers Dis. 2017;4(1):3-11. doi: 10.14283/jpad.2017.1.

    PubMed 29188853
  • Daniel MH, Wahlstrom D, Zhang O. Equivalence of Q-interactive® and Paper Administrations of Cognitive Tasks: WISC®-V. NCS Pearson Inc.; 2014.

  • Delis DC, Kaplan E, Kramer JH. D-KEFS - Delis Kaplan Executive Functions System - Technical Manual. San Antonio: Pearson; 2001.

  • Dikmen SS, Machamer JE, Winn HR, Temkin NR. Neuropsychological Outcome at 1-Year Post Head-Injury. Neuropsychology. 1995;9(1):80-90.

  • van der Naalt J, van Zomeren AH, Sluiter WJ, Minderhoud JM. One year outcome in mild to moderate head injury: the predictive value of acute injury characteristics related to complaints and return to work. J Neurol Neurosurg Psychiatry. 1999 Feb;66(2):207-13. doi: 10.1136/jnnp.66.2.207.

    PubMed 10071101
  • Sun JH, Tan L, Yu JT. Post-stroke cognitive impairment: epidemiology, mechanisms and management. Ann Transl Med. 2014 Aug;2(8):80. doi: 10.3978/j.issn.2305-5839.2014.08.05.

    PubMed 25333055
  • Yang Y, Tang BS, Guo JF. Parkinson's Disease and Cognitive Impairment. Parkinsons Dis. 2016;2016:6734678. doi: 10.1155/2016/6734678. Epub 2016 Dec 12.

    PubMed 28058128
  • Holmes GL. Cognitive impairment in epilepsy: the role of network abnormalities. Epileptic Disord. 2015 Jun;17(2):101-16. doi: 10.1684/epd.2015.0739.

    PubMed 25905906
  • Pendergrass JC, Targum SD, Harrison JE. Cognitive Impairment Associated with Cancer: A Brief Review. Innov Clin Neurosci. 2018 Feb 1;15(1-2):36-44.

    PubMed 29497579
  • Lezak MD, Howieson DB, Loring DW. Neuropsychological Assessment. 4 ed. New York: Oxford University Press; 2004.

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury and Stroke, run by Umeå 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nils Berginström, PhD (+46(0)90-786 88 64, nils.berginstrom@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validity of Rey Auditory Verbal Learning Test in Mindmore (time frame: Baseline). The study lists 6 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 NCT05819008, which also lists 28 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 1 Apr 2026.

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