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Holter of Movement in Patients With SMA Undergoing Treatment.

U

University Hospital Center (CHU) of Liege

Status

Active, not recruiting

Conditions

Spinal Muscular Atrophy

Treatments

Device: Actimyo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04888702
ActiSMA.

Details and patient eligibility

About

Acti-SMA is a multi-centric academic study. It aims to monitor the progress of patients with spinal muscular atrophy under treatment with Spinraza° or risdiplam. First, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. A secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.

Enrollment

30 estimated patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Genetically confirmed spinal muscular atrophy.
  • Treatment by Spinraza ° or by risdiplam planned.
  • Over 6 years old.
  • Signed informed consent.

Exclusion criteria

  • Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

SMA patients
Experimental group
Description:
Patients with type 2 or 3 spinal muscular atrophy undergoing Spinraza° or risdiplam treatment.
Treatment:
Device: Actimyo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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