NCT04080817

Neolexon® Aphasia-App in Acute Aphasia After Stroke

Prospective, Randomized, Clinical & Experimental Controlled Noninvasive Study for Neolexon® Aphasia-App in Acute Aphasia After Stroke

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Up to now there is proven evidence of traditional logopedic therapy in aphasia, but recent computer-based algorithms also showed their evidence so far. Due to small and heterogenous study populations further trials are urgently needed. This prospective, randomized, clinical \& experimental controlled noninvasive study is intended to provide data for the therapy of an individual approach in aphasia patients.

Detailed description

The prospective, randomized, clinical \& experimental controlled noninvasive study (Lexi) is intended to start in 10/2019. Adult and German speaking patients suffering from aphasia after stroke who give informed consent and whose life expectancy is estimated above 1 year are included and will be followed up for 3 months. If informed consent is not available their legal guardian will have to provide written informed consent for their contribution. After Randomization participants are divided into two different groups: Patients receiving a standard logopedic speech treatment versus individuals working with a computer-based solution (Neolexon® App on mobile devices). Both groups will also have self-training and therefore frequency and intensity of this is also going to be analyzed as well as in the clinical surrounding. There will be three different major ward rounds in both groups during the trial period where scales scoring the severity of aphasia are collected and compared (i.e. AABT or LAST). Furthermore epidemiologic data and stroke scales (i.e. NIHSS, mRS) are evaluated. The last round will be the follow-up after 3 months. Lexi will provide new data to fill the gap of organizational barriers and structural problems. Our aim is to show modern alternative therapy algorithms that approach the individual problem to offer a potential tailored solution to patients.

Conditions

• Aphasia, Acquired
• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	Neolexon	Application (Neolexon) on Tablet. Same frequency \& intensity as in the other interventions
OTHER	Speech therapy	standard logopedic speech therapy. Same frequency \& intensity as in the other interventions
OTHER	Self training	Same frequency \& intensity as in the other interventions

Timeline

• Start date: 2019-10-01
• Primary completion: 2019-11-01
• Completion: 2020-02-01
• First posted: 2019-09-06
• Last updated: 2019-09-10

Locations

1 site across 1 country: Germany