Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.

NCT06228001 | Recruiting FDA Device

• 1 other identifier: ActiALS study
• Study Type: observational
• Target: 30
• Locations: 2 countries
• Sites: 3

Brief Summary

ActiALS is a multicentric academic study. Patients with amyotrophic lateral sclerosis (ALS) may be included on a voluntary basis. The investigators plan to include a group of approximately 30 patients with ALS. The investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Actimyo; Accelerometry; Daily living

Outcome Measures

Primary Outcomes (4)

• Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point

  95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

  1 year

• Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point

  50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

  1 year

• Difference in 95th centile of stride length between baseline and one year follow up- or last time point

  95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

  1 year

• Difference in 50th centile of stride length between baseline and one year follow up- or last time point

  50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

  1 year

Secondary Outcomes (1)

• Upper limb function evolution in patient with ALS

  1 year

Interventions

Actimyo DEVICE

Actimyo is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.

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 diagnosed with amyotrophic lateral sclerosis

You may qualify if:

• Clinically defined or probable diagnosis of ALS according to El Escorial criteria revised with Awaji's electro-diagnostic algorithm.
• Over 18 years old.
• Signed informed consent
• If patient on Riluzole, the dosage should be stable for 1 month and continued throughout the study period.

You may not qualify if:

• Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
• Any other previous or present pathology having an impact on motor function.
• Recent surgery or trauma (less than 6 months) in the upper or lower limbs.
• Patients participating in an interventional clinical trial.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• SYSNAV: collaborator

Study Sites (3)

Katholieke Universiteit Leuven

Leuven, 1425, Belgium

RECRUITING

Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle

Liège, 4000, Belgium

RECRUITING

Galaa Military Medical Complex

Cairo, Egypt

ACTIVE NOT RECRUITING

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

• Stéphanie Delstanche, MD

  Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie Medard

CONTACT

+3243218222; laurie.medard@citadelle.be

Margaux Poleur, MD

CONTACT

+3243216127; margaux.poleur@citadelle.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 29, 2024
• Study Start: May 1, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1); BE (2)