Dementia AlzheimersNCT05606445
Surface EMG to Measure Paratonia in Dementia
An observational study of Dementia Alzheimers, run by University Medical Center Groningen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- Elbow movement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
In order to be eligible to participate in this study, healthy participants must meet all of the following criteria:
- Age within one of the age-ranges described above.
- Intact cognitive function (MOCA > 26).
As for the people with AD, we will use the following inclusion criteria:
- 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).
About this study
Official title: Understanding and Objectively Measuring Paratonia in Persons With Dementia: a Surface Electromyography Approach
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.
Read more
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.
Read the detailed description
Nearly 300.000 people in the Netherlands and approximately 55 million people worldwide (WHO) suffer from dementia. With 60 - 70% of all cases, Alzheimer's disease (AD) is the most common form of dementia. While AD is mostly associated with cognitive dysfunction, motor symptoms - as acknowledged in DSM-5 - are part of the neurocognitive domain and have shown to precede cognitive decline in people with AD. These data highlight that dementia not only involves cognitive but also motor components. As such, objective screening tools that can detect these motor symptoms are critical yet unavailable.
A prominent and degenerative motor symptom related to AD is paratonia. Paratonia was first described almost two centuries ago and defined as increased muscle tone during passive movements that is proportional to the strength of the stimulus applied up to the production of counter-movements in the later stages of dementia. Paratonia, therefore, is a motor symptom of AD that heavily affects the quality of life and is often misunderstood and mistaken for behavior of a psychosocial nature. However, despite their impact, motor symptoms of AD receive surprisingly little attention. Indirect evidence suggests that paratonia results from central, i.e., frontal lobe disinhibition, as well as peripheral, i.e., impaired skeletal muscle function due to collagen cross-linking and intramuscular inflammation. Based on these data, it can be argued that paratonia can be objectively quantified using non-invasive electrophysiological measurements. Once developed, such accessible and low-cost screening tool provide evidence for the presence and severity of motor symptoms of dementia in clinical settings besides symptoms of cognitive decline.
Currently, the presence and severity of paratonia are assessed with, respectively, the subjective paratonia assessment instrument (PAI) and the subjective Modified Ashworth Scale for Paratonia (MAS-P). However, objective tools to examine paratonia in people with dementia are not available and as such, the diagnosis of paratonia relies solely on subjective interpretation of clinicians. In a recent review, our research group highlighted the various gaps of knowledge in paratonia-research related to the poor recognition of paratonia and the lack of clear guidance for health professionals. Because eExperimental evidence suggested the possibility to measure paratonia through muscle activity. ,This possibility arises from the hypothesis that the increased muscle tone results from lesions in the frontal cortex in people with dementia and consequently increased disinhibition of the motor cortex. In addition, it is also possible that the heightened muscle tone is (partly) caused by disturbed interactions between ascending sensory inputs and descending motor output. As such, it is reasonable to hypothesize paratonia can be objectively characterized by neurophysiological motor and corticomotor parameters. Moreover, there are indications that motor symptoms precede cognitive decline in people with dementia. Therefore, the goals of the proposed project are threefold and focus on (1) examining whether it is possible to the development of an objectively and non-invasively quantifyassessment the development of paratonia with a tool method based on surface electromyography (sEMG) to quantify paratonia, (2) examining the development of the relationship between motor symptoms of AD and cognitive and physical function from preclinical healthy adults to increasing severity of dementia and (3) identifying the contribution of underlying neuromuscular dysfunctions that are associated with the development of paratonia.
- Conditions
- Dementia Alzheimers
- Being tested
- Elbow movement
- Keywords
- Paratonia, Neuromotor
- Medical subject headings
- Alzheimer Disease, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow movementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy young (18-30 years old) (n = 40). This group will be used to assess the development of paratonia in healthy conditions. Receives: 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. Receives: Behavioral: Elbow movement | |
| 3 | Healthy old (>65y) (n = 40). This group will be used to assess the development of paratonia in healthy conditions. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Elbow movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
As a measure of cognitive function, we will use the Montreal Cognitive Assessment.
Measured: The measure 'cognitive function' will be estimated from the Montreal Cognitive Assessment taken on Day 1 of the experiment.
physical function
As a measure of physical function, we will use the Timed-Up and Go test and measure the time it takes (in seconds) to rise from a chair and walk three meters at comfortable speed, walk back and get seated again.
Measured: The measure 'physical function' will be estimated from the Timed Up and Go test taken on Day 1 of the experiment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia AlzheimersStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Hanzehogeschool Groningen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606445
- Sponsor's protocol ID
- NL81562.042.22
- Status last verified
- Nov 2022
- First submitted
- 27 Sep 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Objectively Measuring Paratonia in Persons With Dementia: a Surface Electromyography Approach
- ClinicalTrials.gov ID
- NCT05606445
- Acronym / sponsor ID
- NL81562.042.22
- Conditions
- Dementia Alzheimers
- Keywords
- Paratonia, Neuromotor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Hanzehogeschool Groningen
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nearly 300.000 people in the Netherlands and approximately 55 million people worldwide (WHO) suffer from dementia. With 60 - 70% of all cases, Alzheimer's disease (AD) is the most common form of dementia. While AD is mostly associated with cognitive dysfunction, motor symptoms - as acknowledged in DSM-5 - are part of the neurocognitive domain and have shown to precede cognitive decline in people with AD. These data highlight that dementia not only involves cognitive but also motor components. As such, objective screening tools that can detect these motor symptoms are critical yet unavailable.
A prominent and degenerative motor symptom related to AD is paratonia. Paratonia was first described almost two centuries ago and defined as increased muscle tone during passive movements that is proportional to the strength of the stimulus applied up to the production of counter-movements in the later stages of dementia. Paratonia, therefore, is a motor symptom of AD that heavily affects the quality of life and is often misunderstood and mistaken for behavior of a psychosocial nature. However, despite their impact, motor symptoms of AD receive surprisingly little attention. Indirect evidence suggests that paratonia results from central, i.e., frontal lobe disinhibition, as well as peripheral, i.e., impaired skeletal muscle function due to collagen cross-linking and intramuscular inflammation. Based on these data, it can be argued that paratonia can be objectively quantified using non-invasive electrophysiological measurements. Once developed, such accessible and low-cost screening tool provide evidence for the presence and severity of motor symptoms of dementia in clinical settings besides symptoms of cognitive decline.
Currently, the presence and severity of paratonia are assessed with, respectively, the subjective paratonia assessment instrument (PAI) and the subjective Modified Ashworth Scale for Paratonia (MAS-P). However, objective tools to examine paratonia in people with dementia are not available and as such, the diagnosis of paratonia relies solely on subjective interpretation of clinicians. In a recent review, our research group highlighted the various gaps of knowledge in paratonia-research related to the poor recognition of paratonia and the lack of clear guidance for health professionals. Because eExperimental evidence suggested the possibility to measure paratonia through muscle activity. ,This possibility arises from the hypothesis that the increased muscle tone results from lesions in the frontal cortex in people with dementia and consequently increased disinhibition of the motor cortex. In addition, it is also possible that the heightened muscle tone is (partly) caused by disturbed interactions between ascending sensory inputs and descending motor output. As such, it is reasonable to hypothesize paratonia can be objectively characterized by neurophysiological motor and corticomotor parameters. Moreover, there are indications that motor symptoms precede cognitive decline in people with dementia. Therefore, the goals of the proposed project are threefold and focus on (1) examining whether it is possible to the development of an objectively and non-invasively quantifyassessment the development of paratonia with a tool method based on surface electromyography (sEMG) to quantify paratonia, (2) examining the development of the relationship between motor symptoms of AD and cognitive and physical function from preclinical healthy adults to increasing severity of dementia and (3) identifying the contribution of underlying neuromuscular dysfunctions that are associated with the development of paratonia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Elbow movementHealthy young (18-30 years old) (n = 40). This group will be used to assess the development of paratonia in healthy conditions. |
| 2 | – | Behavioral: Elbow movementHealthy middle aged (40-55y) (n = 40). This group will be used to assess the development of paratonia in healthy conditions. |
| 3 | – | Behavioral: Elbow movementHealthy old (>65y) (n = 40). This group will be used to assess the development of paratonia in healthy conditions. |
| 4 | – | Behavioral: Elbow movementPeople with mild cognitive impairment (n = 40). This group will be used to assess the severity of paratonia in the various stages of dementia. |
| 5 | – | Behavioral: Elbow movementPeople 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. |
| 6 | – | Behavioral: Elbow movementPeople 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. |
| 7 | – | Behavioral: Elbow movementPeople 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elbow movementThe 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. | Behavioural | 1, 2, 3, 4, 5, 6, 7 |
Primary outcome
Root mean square
Time frame: The measure 'root mean square' will be computed from electromyography data acquired during the session on Day 1 of the experiment.
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.
Co-contraction index
Time frame: The measure 'co-contraction index' will be computed from electromyography data acquired during the session on Day 1 of the experiment.
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.
corticomuscular coherence
Time frame: The measure 'corticomuscular coherence' will be computed from electromyography and electroencephalography data acquired during the session on Day 1 of the experiment.
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.
corticokinematic coherence
Time frame: The measure 'corticokinematic coherence' will be computed from electroencephalography and goniometer data acquired during the session on Day 1 of the experiment.
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.
2 secondary outcomes
cognitive function
Time frame: The measure 'cognitive function' will be estimated from the Montreal Cognitive Assessment taken on Day 1 of the experiment.
physical function
Time frame: The measure 'physical function' will be estimated from the Timed Up and Go test taken on Day 1 of the experiment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia Alzheimers, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root mean square (time frame: The measure 'root mean square' will be computed from electromyography data acquired during the session on Day 1 of the experiment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.