Remote Neuropsychological Assessment of Patients With Neurological Disorders and Injuries

NCT05819008 | Recruiting

• 1 other identifier: 7004076
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Can the results from Mindmore Distance be transferred into neuropsychological profiles that can be used in diagnostics for specific patient groups?
3. 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?

Conditions

Traumatic Brain Injury; Stroke; Multiple Sclerosis; Parkinson Disease; Epilepsy; Brain Tumor

Keywords

Neuropsychological assessment

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• Validity of FAS in Mindmore

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

  Baseline

Study Arms (1)

Patients with neurological disorders or injuries and Healthy Controls

Diagnostic Test: Neuropsychological Assessment

Interventions

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).

Patients with neurological disorders or injuries and Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• Västerbotten County Council, Sweden: collaborator

Study Sites (1)

Umeå University Hospital

Umeå, 90185, Sweden

RECRUITING

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  PMID: 38653513 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Multiple Sclerosis; Parkinson Disease; Epilepsy; Brain Neoplasms

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Nils Berginström, PhD

  Umeå Universitet, Department of Psychology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nils Berginström, PhD

CONTACT

+46(0)90-786 88 64; nils.berginstrom@umu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 19, 2023
• Study Start: March 10, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)