Surface EMG to Measure Paratonia in Dementia

NCT05606445 | Unknown DMC

• 1 other identifier: NL81562.042.22
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rationale: A prominent and degenerative motor symptom of dementia is paratonia that heavily affects quality of life. However, paratonia is poorly recognized and the diagnosis yet relies on subjective evaluation by caregivers. Objective: The primary aim of the proposed study is to develop a surface-electromyography-based method to objectively quantify paratonia in people with dementia. In addition, we aim to increase the understanding of the role of neuromuscular dysfunctions that contribute to paratonia. Study design: Cross-sectional study, in people of various ages and at older age with different levels of cognitive impairment and neuromuscular functioning, in which we will examine the association between their physical and cognitive function and neuromuscular outcome measures. Study population: Healthy young (18-30y, n = 40), middle-age (40-55y, n = 40) and older adults (\>65y; n = 40). In addition, people with mild cognitive impairment (n = 40) as well as people with mild (n = 40), moderate (n = 40) and severe (n = 40) dementia. Main study parameters/endpoints: Cognitive function, physical function, neuromuscular function expressed by muscle- and brain activity as well as coordination.

Conditions

Dementia Alzheimers

Keywords

Paratonia; Neuromotor

Outcome Measures

Primary Outcomes (4)

• Root mean square

  From EMG data measured during flexion and extension movements, we will calculate the root mean square to assess the influence of movement velocity and shape as well as focus of attention on agonist and antagonist muscle activity.

  The measure 'root mean square' will be computed from electromyography data acquired during the session on Day 1 of the experiment.

• Co-contraction index

  From EMG data measured during flexion and extension movements, we will calculate the co-contraction index to assess the influence of movement velocity and shape as well as focus of attention on the control of agonist and antagonist muscle activity.

  The measure 'co-contraction index' will be computed from electromyography data acquired during the session on Day 1 of the experiment.

• corticomuscular coherence

  From EMG and EEG data measured during flexion and extension movements, we will calculate the corticomuscular coherence to assess the influence of movement velocity and shape as well as focus of attention on the connectivity between the brain and the muscles involved in the movement.

  The measure 'corticomuscular coherence' will be computed from electromyography and electroencephalography data acquired during the session on Day 1 of the experiment.

• corticokinematic coherence

  From goniometer and EEG data measured during flexion and extension movements, we will calculate the corticokinetic coherence to assess the influence of movement velocity and shape as well as focus of attention on the proprioceptive function during the involved movements.

  The measure 'corticokinematic coherence' will be computed from electroencephalography and goniometer data acquired during the session on Day 1 of the experiment.

Secondary Outcomes (2)

• cognitive function

  The measure 'cognitive function' will be estimated from the Montreal Cognitive Assessment taken on Day 1 of the experiment.

• physical function

  The measure 'physical function' will be estimated from the Timed Up and Go test taken on Day 1 of the experiment.

Study Arms (7)

1

Healthy young (18-30 years old) (n = 40). This group will be used to assess the development of paratonia in healthy conditions.

Behavioral: Elbow movement

2

Healthy middle aged (40-55y) (n = 40). This group will be used to assess the development of paratonia in healthy conditions.

Behavioral: Elbow movement

3

Healthy old (\>65y) (n = 40). This group will be used to assess the development of paratonia in healthy conditions.

Behavioral: Elbow movement

4

People with mild cognitive impairment (n = 40). This group will be used to assess the severity of paratonia in the various stages of dementia.

Behavioral: Elbow movement

5

People with mild dementia according to the Clinical Dementia Rating (n = 40). This group will be used to assess the severity of paratonia in the various stages of dementia.

Behavioral: Elbow movement

6

People with moderate dementia according to the Clinical Dementia Rating (n = 40). This group will be used to assess the severity of paratonia in the various stages of dementia.

Behavioral: Elbow movement

7

People with severe dementia according to the Clinical Dementia Rating (n = 40). This group will be used to assess the severity of paratonia in the various stages of dementia.

Behavioral: Elbow movement

Interventions

Elbow movement BEHAVIORAL

The behavioral paradigm consist of a passive and active movement condition. Both conditions consist of arm movements along the entire range of motion by moving the distal segment of the arm towards the proximal segment and back under varying conditions. In the 'passive' condition, this arm movement will be performed by researcher at 3 different velocities in sinusoidal (continuous) and linear (non-continuous) fashions whereas in the 'active' condition, the participant will be instructed to move the arm in one velocity under internal and external focus of attention.

1; 2; 3; 4; 5; 6; 7

Eligibility Criteria

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

Study Population

We aim to include healthy young (18 - 30 y, n = 40), middle-aged (40 - 55 y, n = 40) and older adults (\> 65 y; n = 40). In addition, we aim to include people with mild cognitive impairment (n = 40) as well as people with mild AD (n = 40), moderate AD (n = 40) and severe AD (n = 40). The severity of AD will be determined using the Clinical Dementia Rating.

You may qualify if:

• Diagnosed mild cognitive impairment (CDR score 0.5), mild dementia (CDR score 1), moderate dementia (CDR score 2) or severe dementia (CDR score 2).
• Able to sit independently.
• A potential healthy participant who meets any of the following criteria will be excluded from participation in this study:
• A history of central neurological problems (e.g. cerebral vascular attacks, epilepsy, acquired brain damage or Parkinson's Disease) or peripheral nerve problems.
• Intake of medication that substantially affects the functioning of the nervous system in the three months prior to the assessment. This includes psychotropic medication (ATC codes N03A, N05A, N05B, N05C, N06A, N06B), anti-migraine and analgesics.
• A potential participant with dementia will be excluded from participation if:
• The participant has experienced intercurrent diseases that negatively affected cognitive and motor function.
• The participant has a fever at the time of the assessment.
• The participant is deliriant.
• The participant is terminally ill (i.e., life expectancy \< 2 weeks according to the attending physician).

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Hanzehogeschool Groningen: collaborator

MeSH Terms

Conditions

Alzheimer Disease; Muscle Rigidity

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: November 4, 2022
• Study Start: November 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share