NCT04729257已完成不适用
Norms Expansion and Validation for IntelliSpace Cognition
Philips Electronics Nederland B.V. acting through Philips CTO organization1 个研究点 分布在 1 个国家目标入组 508 人开始时间: 2021年3月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 508
- 试验地点
- 1
- 主要终点
- 1. Scores digital (ISC) tests [Time Frame: 1.5 hours]. Scores retrieved from all cognitive tests on the ISC platform.
研究概览
简要总结
This study aims to expand the normative dataset for Philips IntelliSpace Cognition to include ages 18-49 and 80+ and aims to validate two new digital tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is 18 years or older.
- •Participant's primary language (language most often spoken) must be American English.
- •Participant is able to see well (naturally or corrected by means of eyeglasses or lenses).
- •Participant is able to hear well (naturally of corrected by means of a hearing aid).
- •Participant is able to use their fingers, hands and arms to write symbols.
- •Participant has valid health insurance in USA.
- •Participant is able to give informed consent.
- •Participant is able to understand test instructions and participate fully in testing.
- •Participant has normal fine and gross motor ability.
排除标准
- •Inclusion Criteria:
- •Participant is 18 years or older.
- •Participant's primary language (language most often spoken) must be American English.
- •Participant is able to see well (naturally or corrected by means of eyeglasses or lenses).
- •Participant is able to hear well (naturally of corrected by means of a hearing aid).
- •Participant is able to use their fingers, hands and arms to write symbols.
- •Participant has valid health insurance in USA.
- •Participant is able to give informed consent.
- •Participant is able to understand test instructions and participate fully in testing.
- •Participant has normal fine and gross motor ability.
- •Exclusion Criteria:
- •Participant is currently admitted to a hospital, assisted living, nursing home or a psychiatric facility.
- •Participant is diagnosed with a neurological disorder or disease that may affect cognitive functioning (e.g., Parkinson's, brain tumor, stroke, Traumatic Brain Injury (TBI), epilepsy [if # seizures ≤ 2 and not receiving ongoing treatment for seizures, and not currently seeking medical evaluation or attention related to seizures, participant can be accepted], encephalitis, dementia).
- •Participant is diagnosed with a language disorder or aphasia (expressive or mixed receptive/expressive) [if articulation disorder, participant can be accepted].
- •Participant is diagnosed with a learning disorder.
- •Participant is diagnosed with an autoimmune disorder that may affect cognitive functioning (e.g., LUPUS, Multiple Sclerosis).
- •Participant is or was diagnosed with a current or past psychotic disorder (e.g., schizophrenia).
- •Participant is diagnosed with a severe mood disorder [if Major Depressive Disorder in remission or with no current episode or Dysthymic Disorder or Adjustment Disorder, participant can be accepted].
- •Participant is diagnosed with a severe anxiety disorder [if Phobia or Anxiety disorders with symptoms not significant enough to interfere with test performance, participant can be accepted].
- •Participant is or was diagnosed with current or past Autism Spectrum Disorder or Intellectual Disability.
- •Participant is diagnosed with a current substance abuse or dependence [if in remission ≥ 1 year, participant can be accepted].
- •Participant has carried a substance abuse or dependence diagnosis for more than 10 years at any point in their life.
- •Participant has an average alcohol consumption of 4 or more units per day.
- •Participant uses medical marijuana.
- •Participant uses recreational marijuana more than once a week.
- •Participant uses recreational drugs other than alcohol and marijuana in the last 6 months (e.g., cocaine, ecstasy, LSD).
- •Participant has been unconscious related to traumatic brain injury or 'medical condition' for more than 20 minutes [if medication-induced or due to heat stroke, participant can be accepted].
- •Participant has stayed in a hospital overnight due to a head injury.
- •Participant has had a medical event requiring resuscitation in which they were non-responsive for more than 15 minutes.
- •Participant has received chemotherapy treatment in the past 2 months.
- •Participant has received electroconvulsive therapy (ECT).
- •Participant has received radiation to the central nervous system.
- •Participant experiences a physical condition or illness that interferes with normal cognitive functioning at work, school, Instrumental Activities of Daily Living (IADLs) etc. [if diabetes or hypothyroidism or hypertension and if controlled, participant can be accepted].
- •Participant is currently taking anti-convulsants (Depakote, Lamictal or Lyrica, Gabapentin, Keppra, Topamax, Divalproex Sodium, Valproate Sodium, Levetiracetam, Lamotrigine, Pregabalin, Topiramate).
- •Participant is currently taking anti-psychotics (Abilify, Rexulti, Zyprexa, Clozaril, Clozapine, Latuda, Seroquel, Risperdal, Risperidone, Aripipazle, Bexipiprazole, Olanzapine, Lurasidone HCL, Quetiapine).
- •Participant is currently taking benzodiazepines (Diazepams, Valium, Klonopin, Ativan, Xanax, Lorazepam, Alprazolam, Clonazepam).
- •Participant is currently taking psychostimulants (Amphetamines, Adderall, Ritalin, Methamphetamines, Dextroamphetamine, Methylphenidate HCL). [if coffee, participant can be accepted].
- •Participant is currently taking opioids (Oxycontin, Tramadol, Codeine, Dilaudid, Suboxone, Oxycodone, Percocet, Buprenorhine, Naloxone).
- •Participant is currently taking antidepressants (Amitriptyline, Elavil, Pamelor, Tofranil, Vivactil, Imipramine, Protriptyline HCL). [if antidepressant that are not tricyclic, participant can be accepted].
- •Participant is currently taking oxybutynin (Ditropan).
- •Participant is currently seeking medical diagnostic procedures for cognitive difficulties from a medical professional.
- •Participant has received neuropsychological testing before. [if previous MMSE(-2) or MoCA testing more than 6 months prior, participant can be accepted].
- •Participant shows evidence of current cognitive impairment.
- •Participant displays disruptive behavior or insufficient compliance with testing to ensure a valid assessment.
- •Participant is primarily nonverbal or uncommunicative.
研究组 & 干预措施
Group F (Norms, 80-95 years)
Other
Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A
干预措施: Philips IntelliSpace Cognition (ISC). (Device)
Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years)
Other
Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using paper-pencil tests.
干预措施: Philips IntelliSpace Cognition (ISC). (Device)
Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years)
Other
Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using paper-pencil tests.
干预措施: Paper-Pencil Tests. (Diagnostic Test)
Group B (Validation, 18+)
Other
Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using digital tests.
干预措施: Philips IntelliSpace Cognition (ISC). (Device)
Group B (Validation, 18+)
Other
Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using digital tests.
干预措施: Paper-Pencil Tests. (Diagnostic Test)
Group C1 (Norms + Validation, 18-49 years) + Group C2 (Validation, 50+ years)
Other
Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using digital tests.
干预措施: Philips IntelliSpace Cognition (ISC). (Device)
Group D (Validation, 18+)
Other
Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using paper-pencil tests.
干预措施: Paper-Pencil Tests. (Diagnostic Test)
Group E (Norms, 18-49 years)
Other
Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A
干预措施: Philips IntelliSpace Cognition (ISC). (Device)
结局指标
主要结局
1. Scores digital (ISC) tests [Time Frame: 1.5 hours]. Scores retrieved from all cognitive tests on the ISC platform.
时间窗: 1.5 hours
or 1.5 hours]. Scores retrieved from Symbol Digit Modalities Test (SDMT) + Naming Test (NT) or all paper-based cognitive tests
时间窗: 0.75 h or 1.5 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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