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Holter of Movement in Patients With Amyotrophic Lateral Sclerosis. (ActiALS)

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ClinicalTrials.gov Identifier: NCT06228001
Recruitment Status : Recruiting
First Posted : January 29, 2024
Last Update Posted : April 26, 2024
Sponsor:
Collaborators:
SYSNAV
Centre Hospitalier Régional de la Citadelle
Information provided by (Responsible Party):
Laurent Servais, Centre Hospitalier Universitaire de Liege

Study Description
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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.


Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Device: Actimyo

Detailed Description:

On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores.

Participants will perform few tests (6-minutes walk test (6MWT), dynamometric measure, electromyography, and will answer to some questionaires (dysphagia handicap scale, Revised Amyotrophic Lateral Sclerosis Functional Rating Scale).

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Actimyo
    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.

Outcome Measures
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Primary Outcome Measures :
  1. Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point [ Time Frame: 1 year ]
    95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

  2. Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point [ Time Frame: 1 year ]
    50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

  3. Difference in 95th centile of stride length between baseline and one year follow up- or last time point [ Time Frame: 1 year ]
    95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

  4. Difference in 50th centile of stride length between baseline and one year follow up- or last time point [ Time Frame: 1 year ]
    50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).


Secondary Outcome Measures :
  1. Upper limb function evolution in patient with ALS [ Time Frame: 1 year ]
    Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with amyotrophic lateral sclerosis
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion.
  • Patients participating in an interventional clinical trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06228001


Contacts
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Contact: Laura Buscemi +3243215584 laura.buscemi@citadelle.be
Contact: Margaux Poleur, MD +3243216127 margaux.poleur@citadelle.be

Locations
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Belgium
Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle Recruiting
Liège, Belgium, 4000
Contact: Stephanie Delstanche, MD       stephanie.delstanche@chrcitadelle.be   
Contact: Laura BUSCEMI       laura.buscemi@citadelle.be   
Principal Investigator: Stephanie Delstanche         
Sponsors and Collaborators
Laurent Servais
SYSNAV
Centre Hospitalier Régional de la Citadelle
Investigators
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Principal Investigator: Stéphanie Delstanche, MD Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
More Information
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Responsible Party: Laurent Servais, Professor, Centre Hospitalier Universitaire de Liege
ClinicalTrials.gov Identifier: NCT06228001    
Other Study ID Numbers: ActiALS study
First Posted: January 29, 2024    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Laurent Servais, Centre Hospitalier Universitaire de Liege:
Actimyo
Accelerometry
Daily living
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases