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Neolexon® Aphasia-App in Acute Aphasia After Stroke (Lexi)

L

Ludwig Maximilian University of Munich

Status

Unknown

Conditions

Stroke, Acute
Aphasia, Acquired

Treatments

Other: Self training
Other: Speech therapy
Device: Neolexon

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Neolexon Therapy
Experimental group
Treatment:
Other: Self training
Device: Neolexon
Standard logopedic therapy
Active Comparator group
Treatment:
Other: Self training
Other: Speech therapy

Trial contacts and locations

1

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Central trial contact

Lars Kellert, MD

Data sourced from clinicaltrials.gov

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