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NCT05606445
Surface EMG to Measure Paratonia in Dementia
Conditions: Dementia Alzheimers
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 280
Sponsor: University Medical Center Groningen
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.
Eligibility Criteria
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).
Source: ClinicalTrials.gov (NCT05606445). StuddyBuddy aggregates publicly available trial information.