Neolexon® Aphasia-App in Acute Aphasia After Stroke

NCT04080817 | Unknown

• 1 other identifier: 19-068
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia, Acquired; Stroke, Acute

Keywords

Stroke; Aphasia; Speech therapy; Computer based

Outcome Measures

Primary Outcomes (8)

• Epidemiologic Data

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

  3 months

• 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.

  3 months

• 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".

  3 months

• 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.

  3 months

• BI

  Barthel Index

  3 months

• LAST

  Language Screening Test

  3 months

• AABT

  Aachener Aphasie Bedside Test

  3 months

• ACL

  Aphasie Check Liste

  3 months

Secondary Outcomes (2)

• EQ-5D-5L

  3 months

• BDI

  3 months

Study Arms (2)

Neolexon Therapy

EXPERIMENTAL

Device: Neolexon; Other: Self training

Standard logopedic therapy

ACTIVE COMPARATOR

Other: Speech therapy; Other: Self training

Interventions

Neolexon DEVICE

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

Neolexon Therapy

Speech therapy OTHER

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

Standard logopedic therapy

Self training OTHER

Same frequency \& intensity as in the other interventions

Neolexon Therapy; Standard logopedic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

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

Munich, Bavaria, 81377, Germany

Location

Related Publications (2)

• 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.

  PMID: 41294376 DERIVED

• 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.

  PMID: 32425873 DERIVED

MeSH Terms

Conditions

Aphasia; Stroke; Communication Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Katharina Feil, MD

  Ludwig Maximlians University (LMU) Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Kellert, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: February 1, 2020
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)