Clinical trial NCT04080817: Neolexon® Aphasia-App in Acute Aphasia After Stroke
Official title: Prospective, Randomized, Clinical & Experimental Controlled Noninvasive Study for Neolexon® Aphasia-App in Acute Aphasia After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aphasia, Acquired
Stroke, Acute
Keywords: Stroke
Aphasia
Speech therapy
Computer based
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Acute Aphasia after stroke (ischemic oder hemorrhagic)
* Life expectancy ≥ 1 year
* Informed consent (presumed)
* Mother tongue: german

Exclusion Criteria:

* Age \< 18 years
* Missing aphasia
* Life expectancy \< 1 year
* Mother tongue: other then german

Primary outcomes:
measure: Epidemiologic Data
timeFrame: 3 months
measure: NIHSS
timeFrame: 3 months
measure: p-mRS
timeFrame: 3 months
measure: mRS
timeFrame: 3 months
measure: BI
timeFrame: 3 months
measure: LAST
timeFrame: 3 months
measure: AABT
timeFrame: 3 months
measure: ACL
timeFrame: 3 months
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: 3 months
measure: BDI
timeFrame: 3 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilians University (LMU) Munich, Department of Neurology with Friedrich-Baur Institute
state: Bavaria
Study officials:
affiliation: Ludwig Maximlians University (LMU) Munich
name: Katharina Feil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thunstedt DC, Young P, Kupper C, Muller K, Becker R, Erbert F, Lehner K, Rheinwald M, Pfahler A, Dieterich M, Kellert L, Feil K. Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon(R)): Study Protocol of the Lexi Study. Front Neurol. 2020 Apr 30;11:294. doi: 10.3389/fneur.2020.00294. eCollection 2020.