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Aphasia, AcquiredLexiNCT04080817

Neolexon® Aphasia-App in Acute Aphasia After Stroke

A study testing Neolexon, Speech therapy and Self training in people with Aphasia, Acquired and Stroke, Acute, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aphasia, Acquired, Stroke, Acute
What is being tested?
Neolexon, Speech therapy and Self training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteGermany
Study dates
1 Oct 2019to 1 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Lars Kellert, MD contact

0049 (0) 89 4400 73962

Lars.Kellert@med.uni-muenchen.de

Germany1 site

  • Ludwig Maximilians University (LMU) Munich, Department of Neurology with Friedrich-Baur Institute

    Munich, Bavaria, 81377

    Lars Kellert, MD, 0049 (0) 89 4400 73962, Lars.Kellert@med.uni-muenchen.de

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Neolexon, Speech therapy, Self training
Keywords
Stroke, Aphasia, Speech therapy, Computer based
Medical subject headings
Aphasia, Stroke, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeolexonDevice

    Application (Neolexon) on Tablet. Same frequency \& intensity as in the other interventions

  • Speech therapyOther

    standard logopedic speech therapy. Same frequency \& intensity as in the other interventions

  • Self trainingOther

    Same frequency \& intensity as in the other interventions

Study groups in NCT04080817
Study groupRoleWhat they receive
Neolexon TherapyExperimentalNot described
Receives: Device: Neolexon; Other: Self training
Standard logopedic therapyActive comparatorNot described
Receives: Other: Speech therapy; Other: Self training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Epidemiologic Data

    age, etiology of stroke, symptoms of stroke, specific stroke therapy (i.e. intravenous thrombolysis/recanalisation),

    Measured: 3 months

  2. NIHSS

    NIHSS "National Institutes of Health Stroke Scale". It is a Scoring System , which objectively quantifies severity of stroke based on weighted evaluation findings.

    Scoring: https://www.stroke.nih.gov/documents/NIH_Stroke_Scale.pdf Calculating/Interpreting: Higher Scores predict poor outcome and high severity of stroke. Low Scores are associated with minimal mortality and good prognosis. The minimum score being 0, and the maximum score being 42. Subscales are summed to a total Score (high score means worse prognosis, low score indicates a good prognosis.

    Measured: 3 months

  3. p-mRS

    premorbid Modified Rankin Scale (mRS): It is a Scoring System , which objectively quantifies disability before stroke in daily activities. Same questions/scores as in "Outcome 4".

    Measured: 3 months

  4. mRS

    1. Modified Rankin Scale (mRS): It is a Scoring System , which objectively quantifies disability after stroke in daily activities.
    2. Scoring http://www.strokecenter.org/wp-content/uploads/2011/08/modified_rankin.pdf
    3. There is only one total score. The minimum possible score is 0 and the maximum possible score is 6. A high score means worse prognosis/dead, low score indicates a good prognosis.
    4. It is summed.

    Measured: 3 months

  5. BI

    Barthel Index

    Measured: 3 months

  6. LAST

    Language Screening Test

    Measured: 3 months

  7. AABT

    Aachener Aphasie Bedside Test

    Measured: 3 months

  8. ACL

    Aphasie Check Liste

    Measured: 3 months

Secondary outcomes (2)

  1. EQ-5D-5L

    "US 5-level EuroQol 5-dimensional questionnaire" Its a scoring tool, which objectively quantfies life quality. It consists of two seperate parts.

    1. I: Scoring the Descriptive System with five dimensions. Each dimension has 5 boxes. 1-5 are scored as 1-5.

    -> There should be only 1 response for each dimension, Missing values can be coded as '9'. Ambiguous values should be treated as missing values.

    Each health state is referred to in terms of a 5 digit code 11111 (best health state), 55555 (worst health state)

    II: Scoring the VAS (visual analogue scale): This scale is numbered from 0 to 100. (100 means the best health you can imagine. 0 means the worst health you can imagine.) An X should be marked in the scale and then the number into a box. (Missing values should be coded as '999'.) https://euroqol.org/docs/Sample_UK__English__EQ-5D-5L_Paper_Self_complete.pdf, https://apersu.ca/wp-content/uploads/2017/07/Measuring-and-valuing-health-using-the-EQ-5D.pdf

    Measured: 3 months

  2. BDI

    Beck Depression Inventory. A self-scoring tool to objectively count the severity of depressive symptoms consisting of 21 questions. Each question ranges from 0 to 3 points. Subscales are summed. Maximum score is possible at 63 (21x3) and minimal score being 0."

    Levels of Depression 1-10 These ups and downs are considered normal 11-16 Mild mood disturbance 17-20 Borderline clinical depression 21-30 Moderate depression 31-40 Severe depression Over 40 Extreme depression"

    Source:

    https://www.google.com/url?sa=t\&rct=j\&q=\&esrc=s\&source=web\&cd=2\&ved=2ahUKEwjd3u362rvkAhVSZ1AKHZJ4CCAQFjABegQIABAC\&url=https%3A%2F%2Fwww.enhertsccg.nhs.uk%2Fsites%2Fdefault%2Ffiles%2Fpathways%2FBeck%2527s%2520Depression%2520Inventory_0.docx\&usg=AOvVaw3MwAYfr0zL21nK88Cn4VTG"

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start1 Oct 2019 (estimated)
  3. Primary completion1 Nov 2019 (estimated)
  4. Study completion1 Feb 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04080817
Sponsor's protocol ID
19-068
Acronym
Lexi
Status last verified
Sep 2019
First submitted
4 Sep 2019
Last updated
10 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wischmann J, Forbrig R, Franzen J, Brasch L, Hafner F, Feil K, Kellert L; LEXI Investigators. Impact of brain frailty on language recovery in patients with acute post-stroke aphasia: a post-hoc analysis of the LEXI randomized controlled trial. Neurol Res Pract. 2026 Jul 30;8(1):58. doi: 10.1186/s42466-026-00516-1.

    PubMed 42533365

  • Wischmann J, Brasch L, Franzen J, Schwierz J, Kovalenko O, Gutmann A, Erbert F, Bussmann L, Lauer J, Dumberger C, Mandl A, Mehringer M, Munsterer A, Spitzer J, Winterhalter L, Frank V, Rheinwald M, Lehner K, Ammer F, Pfahler A, Lampart S, Young C, Young P, Goettert B, Bitzan M, Rinder S, Meier O, Feil K, Kellert L. Tablet-Assisted Speech and Language Therapy for Acute Post-Stroke Aphasia: A Randomized Clinical Trial (LEXI Study). Eur J Neurol. 2025 Dec;32(12):e70443. doi: 10.1111/ene.70443.

    PubMed 41294376

  • 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.

    PubMed 32425873

Questions about this trial

What is this clinical trial studying?

A study testing Neolexon, Speech therapy and Self training in people with Aphasia, Acquired and Stroke, Acute, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lars Kellert, MD (0049 (0) 89 4400 73962, Lars.Kellert@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epidemiologic Data (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04080817, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.

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