NCT06483438

Brief Summary

Alzheimer's disease (AD) is the most common of dementia, and has associated cognitive and motor disorders, with consequences on daily activities, including handwriting. Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations. Changes in this skill are present at different stages of the clinical course of Alzheimer's Disease. The sensorimotor deterioration is observed in handwriting tasks (motion kinematics, such as movement time, speed, and profiles) and brain activity rhythms. Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations, and changes in this skill are present at different stages of the clinical course of dementia. From a theoretical perspective, because sensorimotor deterioration observed in handwriting tasks (motion kinematics, such as movement time, speed, and profiles). Due to the large number of brain areas related to handwriting performance, brain electrical activity analysis can be an early indicator of brain dysfunction. Although there is a lack of validation across healthy and non-healthy populations Electroencephalogram (EEG) measures have the potential for evaluating cognitive performance. This research aims to analyze the suitability of the handwriting assessment protocol, which can contribute to a more in-depth knowledge of this subject and potentially support early identification and treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 9, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

June 7, 2024

Last Update Submit

August 5, 2024

Conditions

Keywords

PreventionElectroencephalographyHandwritingMovement

Outcome Measures

Primary Outcomes (8)

  • Stroke

    A stroke is a series of lines or curves written in a single letter, i.e., the path traced by the pen on the paper. Traces are analyzed movements that unite a movement pattern. A movement pattern can be segmented using 2 segmentation methods: zero crossings of the velocity profile after the velocity peak or the minimum velocity after the velocity peak. This measure is obtained through the software Movalyzer, during the handwriting tasks.

    Baseline

  • Vertical/horizontal start position

    Initial vertical/horizontal position relative to the lower limit of the digitizer area (in cm).

    Baseline

  • Vertical/horizontal size

    Vertical vector difference between the start and end of a stroke (in cm).

    Baseline

  • Slant

    Segment slope, which is estimated by the orientation of the line by minimizing/reducing the sum of the squares of the perpendicular distances of all pixels to the line through the gravity point (in radians).

    Baseline

  • Reaction time

    Is the time from the start of the recording to the start of the trace (in sec).

    Baseline

  • Duration

    Time interval between the first and last samples in a stroke/segment (in sec).

    Baseline

  • Pen pressure

    Average pen pressure values along a stroke (N/m2).

    Baseline

  • Brain activity

    Spectral density mean from the frequency of the three bands (theta, alpha, beta)

    Baseline

Secondary Outcomes (3)

  • Handwriting legibility

    Baseline

  • Handwriting speed

    Baseline

  • Visuomotor integration

    Baseline

Study Arms (1)

Group 1: subjects with dementia Group 2: subjects without dementia o Group/Cohort Description [*]

Group 1: subjects over the age of 50, with a diagnosis of dementia according to DSM-5 criteria and proven by neuropsychological assessment. Group 2: subjects over the age of 50, with no cognitive impairment on the neuropsychological assessment and with no previous neurological and/or psychiatric history or other illnesses that could interfere with the collection of writing data.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from Municipal and Community Associations, Senior Universities and Residential Centre for the Elderly

You may qualify if:

  • Over 50 years of age
  • Portuguese native language

You may not qualify if:

  • \- Previous neurological history (e.g. stroke, traumatic brain injury, multiple sclerosis, among others), psychiatric history or other incapacitating illnesses that could interfere with the collection of writing data. (NOTE that neurological disease is accepted in the dementia group, but co-morbidity of previous and actual neurological diseases will be excluded) Cognitively normal group
  • Over 50 years of age
  • At least three years of schooling
  • \- Presence of neurological history (e.g., stroke, traumatic brain injury, multiple sclerosis, among others), psychiatric history, or other incapacitating illnesses that could interfere with the collection of writing data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Espírito Santo Hospital of Évora

Evora, 7000, Portugal

Location

Casa dos Avós Residence

Ponte de Sôr, 7400, Portugal

Location

Costa Azul Residence

Sesimbra, 2970, Portugal

Location

Related Publications (8)

  • Yan JH, Rountree S, Massman P, Doody RS, Li H. Alzheimer's disease and mild cognitive impairment deteriorate fine movement control. J Psychiatr Res. 2008 Oct;42(14):1203-12. doi: 10.1016/j.jpsychires.2008.01.006. Epub 2008 Feb 15.

    PMID: 18280503BACKGROUND
  • Stergiou N, Harbourne R, Cavanaugh J. Optimal movement variability: a new theoretical perspective for neurologic physical therapy. J Neurol Phys Ther. 2006 Sep;30(3):120-9. doi: 10.1097/01.npt.0000281949.48193.d9.

    PMID: 17029655BACKGROUND
  • Palmis S, Danna J, Velay JL, Longcamp M. Motor control of handwriting in the developing brain: A review. Cogn Neuropsychol. 2017 May-Jun;34(3-4):187-204. doi: 10.1080/02643294.2017.1367654. Epub 2017 Sep 11.

    PMID: 28891745BACKGROUND
  • Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Cut-off scores in MMSE: a moving target? Eur J Neurol. 2010 May;17(5):692-5. doi: 10.1111/j.1468-1331.2009.02907.x. Epub 2009 Dec 29.

    PMID: 20050900BACKGROUND
  • Harbourne RT, Stergiou N. Movement variability and the use of nonlinear tools: principles to guide physical therapist practice. Phys Ther. 2009 Mar;89(3):267-82. doi: 10.2522/ptj.20080130. Epub 2009 Jan 23.

    PMID: 19168711BACKGROUND
  • Garre-Olmo J, Faundez-Zanuy M, Lopez-de-Ipina K, Calvo-Perxas L, Turro-Garriga O. Kinematic and Pressure Features of Handwriting and Drawing: Preliminary Results Between Patients with Mild Cognitive Impairment, Alzheimer Disease and Healthy Controls. Curr Alzheimer Res. 2017;14(9):960-968. doi: 10.2174/1567205014666170309120708.

    PMID: 28290244BACKGROUND
  • Engel-Yeger B, Hus S, Rosenblum S. Age effects on sensory-processing abilities and their impact on handwriting. Can J Occup Ther. 2012 Dec;79(5):264-74. doi: 10.2182/CJOT.2012.79.5.2.

    PMID: 23539771BACKGROUND
  • Dixon RA, Kurzman D, Friesen IC. Handwriting performance in younger and older adults: age, familiarity, and practice effects. Psychol Aging. 1993 Sep;8(3):360-70. doi: 10.1037//0882-7974.8.3.360.

    PMID: 8216956BACKGROUND

Related Links

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Ana Matias, PhD

    University of Évora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher and Assistant Professor

Study Record Dates

First Submitted

June 7, 2024

First Posted

July 3, 2024

Study Start

December 2, 2023

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

August 9, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Yes: There is a plan to make IPD and related data dictionaries available. All IPD that underlie results in a publication will be shared. Specifically, data from variables mentioned previously, age, gender, and group label.

Shared Documents
STUDY PROTOCOL
Time Frame
Starting 6 months after publication
Access Criteria
Researchers who wish to have access to IPD, should contact principal researcher. The request should be done by email, were researchers should indicate: complete name, affiliation, position, and justify their interest. After the request will be evaluated by two of the elements of the research group.

Locations