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Remote Neuropsychological Assessment of Patients With Neurological Disorders and Injuries

ConditionsTraumatic Brain InjuryStrokeMultiple SclerosisParkinson DiseaseEpilepsyBrain Tumor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUmeå University

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Neuropsychological Assessment

    Diagnostic 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).

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Patients with neurological disorders or injuries and Healthy Controls1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

Västerbotten County Council, Sweden

Collaborator

Source ClinicalTrials.gov
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