euromuscular model for MND: Quantifying the effect of motor neuron disease on neural and non-neural properties of the lower limbs

Completed

• Conditions: Lou Gehrigs disease; Motor neuron disease; 10029317

• Registration Number: NL-OMON48095
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. a. MND patients: definite, probable, probable-laboratory supported or
possible ALS according to the El Escorial criteria (Brooks, 2000),
PMA or PLS.
b. Control subjects: no diagnosis of MND or ALS mimics and age- and
gender-matched to
patient groups, intact physical ability to take part in the
experiment.
c. Asymptomatic carriers: carriers of MND-related gene mutations with
no neurological
symptoms associated with MND.
2. Age:18 and older
3. Capable of performing active tests with their right hand; muscle strength
should be above 3 on
the medical research council (MRC) scale27.
4. Capable of thoroughly understanding the study information given; has signed
the informed
consent.

Exclusion Criteria

Exclusion criteria are for all participants:
1. a history of major head trauma or other neurological conditions that could
affect cognition,
2. alcohol dependence syndrome, current use of neuroleptic medications or high
dose
psychoactive medication.
3. History of reaction or allergy to recording environments, equipment and the
recording gels.
4. Tracheostomy, tracheostomal ventilation of any type, (non)-invasive
ventilation.
5. Pregnancy.

Further exclusion criteria for healthy controls and asymptomatic carriers:
6. History of neuromuscular, neurological or active psychiatric disease

Further exclusion criteria for patients:
7. The presence of any active psychiatric disease, and any medical condition
associated with
neuropathy (e.g. diabetes).
8. Any history or presence of brain injury, epilepsy, psychiatric illness and
other cerebral disease.
9. Any intoxication or medication known to have an association with motor
neuron dysfunction,
which might confound or obscure the diagnosis of MND.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A set of neuromuscular properties determined from the uniform examination<br /><br>protocol which is performed on the Wristalyzer.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A set of clinical scores of characteristic symptoms in MND, derived in<br /><br>neurological examination. </p><br>