NCT05976958: RaDiCo-PP

Utility and Validation's Study of a Smartphone Application for Periodic Paralysis

Terminated Last updated 3 March 2026

What this trial tests

trial in Periodic Paralyses in 2 participants. Terminated before completion.

Timeline

25 July 2019

Primary endpoint
2 August 2019

2 August 2019

Quick facts

Lead sponsor	Institut National de la Santé Et de la Recherche Médicale, France
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	2
Start date	25 July 2019
Primary completion	2 August 2019
Estimated completion	2 August 2019
Sites	1 location across France

Conditions studied

• Periodic Paralyses — all drugs for Periodic Paralyses →

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France — full company profile →

Who can join

12 and older, any sex, with Periodic Paralyses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Periodic paralyses (PP) are rare genetic disorders characterized by the occurrence of acute and reversible episodes of muscle weakness. Their episodic and highly variable nature makes it difficult to gather the necessary information for monitoring and therapeutic adaptation. Patients struggle to accurately report the number, duration, severity, and triggers of their attacks that have occurred between two consultations.

Currently, there are no validated scales or tools for precisely and standardizedly assessing paralytic episodes. Ecological Momentary Assessment (EMA) is a real-time data collection method used in research, historically on paper forms and then on expensive and cumbersome electronic devices (PDAs). The widespread use of smartphones opens up a new avenue in this field, and the use of a mobile application as a real-time data collection tool could be perfectly applicable to these conditions with episodic expression. It is hypothesized that systematic and real-time collection of paralysis episode characteristics will improve the quality and accuracy of the collected data, thus enhancing clinicians' understanding of the condition and patient management. Moreover, little is known about the medical and social impact of the disease. To address these specific issues, the investigators propose a study of patients with "Periodic Paralyses" based on prospective collection of clinical and medico-social data during routine consultations and in real-time during paralytic episodes using a dedicated smartphone application developed by Ad Scientiam in collaboration with Dr. Savine Vicart, the study coordinator.

The primary objective of this study is to evaluate the benefit of a smartphone application specifically developed for patients with periodic paralyses to collect real-time information and improve the quality of collected data regarding the characteristics of paralysis episodes (number, duration, intensity, triggering factors, location, treatment) compared to the retrospective questionnaire typically used in consultations.

The secondary objective is to assess the impact of this new data collection method on the medical management of patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.