Peripheral Neurofilament Levels and Amyotrophic Lateral Sclerosis

NCT04455542 | Completed

• 1 other identifier: PUTH2017198
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the correlation between peripheral neurofilament levels and clinical subtypes of amyotrophic lateral sclerosis and the severity of peripheral motor axonal involvement.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; Neurofilament levels

Outcome Measures

Primary Outcomes (1)

• level of neurofilament

  Venous blood 4 ml was extracted from the three groups of patients for determination of the level of neurofilament.

  1 year after recruitment

Study Arms (3)

LMND-ALS

The main clinical manifestations were muscle weakness with atrophy and bundle fibrillation, the pyramidal tract sign was relatively mild, and extensive neurogenic damage with CMAP amplitude decreased could be seen in patients with electromyography.

Other: LMND-ALS

UMND-ALS

The main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP.

Other: UMND-ALS

FAS and FLS

The clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy

Other: FAS and FLS

Interventions

LMND-ALS OTHER

in line with LMND -ALS inclusion criteria, and CMAP amplitude of peripheral motor nerves (CMAP amplitude of the 10 peripheral motor nerves with the most obvious CMAP amplitude decline was selected as the CMAP amplitude for grouping of the patients) was less than the median of CMAP amplitude of LMND -ALS group.

LMND-ALS

UMND-ALS OTHER

The main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP.

UMND-ALS

FAS and FLS OTHER

The clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy.

FAS and FLS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lower motor neuron involvement (LMND-ALS), who have visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017, meet the diagnostic criteria for ALS in 1998.

You may qualify if:

• Patients with lower motor neuron involvement (LMND-ALS), who have visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017, meet the diagnostic criteria for ALS in 1998. The main clinical manifestations were muscle weakness with atrophy and bundle fibrillation, the pyramidal tract sign was relatively mild, and extensive neurogenic damage with CMAP amplitude decreased could be seen in patients with electromyography.
• Patients with upper motor neuron involvement (UMND-ALS): patients with ALS who visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017 and met the diagnostic criteria for ALS in 1998. The main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP.
• Patients with ALS with flail arm syndrome (FAS) and flail leg syndrome (FLS): patients with ALS who met the diagnostic criteria for ALS in 1998 and visited the Department of Neurology of the Third Hospital of Beijing Medical University since August 2017. The clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy.

You may not qualify if:

• Merging other nervous system degenerative diseases (Alzheimer's disease, Parkinson's disease, multiple system atrophy, etc.) to take off the sheath, central nervous system disease, multiple sclerosis, optic myelitis spectrum disorders), peripheral neuropathy (GBS, chronic inflammatory more nerve root sheath sex mental derangement, hereditary peripheral neuropathy, diabetic peripheral neuropathy, vice tumor peripheral neuropathy, secondary to autoimmune diseases ), into the group within a month before the cerebrovascular disease or cerebral or spinal surgery patients.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dongsheng Fan, MD.PHD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 2, 2020
• Study Start: August 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)