Because experimental evidence suggested the possibility to measure paratonia through muscle activity, the primary aim of this study is to develop an objective non-invasive tool based on surface electromyography (sEMG) to quantify the presence and…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is muscle activity, derived from EMG, during active
and passive movements. Outcome measures are root mean square, co-contraction
index, corticomuscular coherence and corticokinetic coherence.
Secondary outcome
- Cognitive function as measured with the Montrial Cognitive Assessment
- Physical function as measured with the Timed-Up-And-Go test
Background summary
Although dementia is mostly associated with deterioration in cognitive
function, movement disorders are also involved in dementia. Paratonia is a
movement disorder in people with dementia that is characterized by increased
muscle tone during passive movements proportional to the stimulus applied and
deteriorates with increased severity of dementia. The increased resistance
during passive movements can ultimately result in countermovements, severely
impacting daily functioning of people with dementia.
Despite their impact, movement disorders in people with dementia receive
surprisingly littel attention. Diagnosis of paratonia relies on subjective
questionnaires completed by health care providers. However, indirect evidence
suggests that paratonia results from disinhibition of the frontal cortex. Based
on these data, one can argue that paratonia can be objectively measured using
non-invasive electrophysiological techniques.
Study objective
Because experimental evidence suggested the possibility to measure paratonia
through muscle activity, the primary aim of this study is to develop an
objective non-invasive tool based on surface electromyography (sEMG) to
quantify the presence and severity of paratonia in people with AD.
Secundairy aims:
- To examine the relationship between paratonia and cognitive and physical
function.
- To identify possible underlying neuromuscular mechanisms associated with
paratonia.
Study design
We will measure the participants' cognitive and physical function. To quantify
paratonia, participants are asked to (let) perform active and passive movements
at three different speeds and under two different attention-conditions. During
these movements, participants' muscle- and brain-activity will be measured
using electromyography and electroencephalography, respectively.
Study burden and risks
Overall, the risks associated with the proposed study are minimal. Participants
can experience muscle fatigue as a result of the repeating conditions/trials.
However, participants are continuously supervised and repeatedly asked whether
they are doing fine. Breaks between conditions can be prolonged if necessary.
As the experiment is non-therapeutic, the experiment has no direct benefits for
the participants. However, all assessments are non-invasive and will be
performed according to established guidelines. Moreover, the study consists in
only one session. As such, we consider the risks of the current study
negligible and the burden for the participants minimal. The proposed group of
participants and patients is essential to achieve our research goals. That is,
paratonia is a motor disorder that is specific for patients with dementia and
its severity increases with advancements in the disease.
Antonius Deusinglaan 1
Groningen 9700AD FA23
NL
Antonius Deusinglaan 1
Groningen 9700AD FA23
NL
Listed location countries
Age
Inclusion criteria
For healthy participants:
- Age in one of the following categories: 18-30y, 40-55y, >65y
- Intact cognitive function (MOCA > 26)
For patients:
- 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.
Exclusion criteria
For healthy participants:
- a history of neurological problems (e.g., CVA, epilepsy or PD) or peripheral
nerve problems.
- Intake of medication that substantially affects the functioning of the
nervous system in the three months prior to the experiment. This includes
psychotropic medication (ATC codes N03A, N05A, N05B, N05C, N06A, N06B),
anti-migraine and analgesics.
For patients:
-The participant has experienced intercurrent diseases that negatively affected
cognitive and motor function.
- The participant has a fever at the time of the experiment.
- The participant is deliriant.
- The participant is terminally ill (i.e., life expectancy < 2 weeks according
to the attending physician).
- People with primary vascular dementia, Lewy Body / Parkinson dementia and
fronto-temporal dementia based on chart diagnosis.
- Intake of medication that substantially affects the functioning of the
nervous system in the three months prior to the experiment. This includes
psychotropic medication (ATC codes N03A, N05A, N05B, N05C, N06A, N06B),
anti-migraine and analgesics.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05606445 |
| CCMO | NL81562.042.22 |