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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke, Acute; Aphasia, Acquired
• Intervention / Treatment: Device: Neolexon; Other: Self training; Other: Speech therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Ludwig Maximilians University (LMU) Munich, Department of Neurology with Friedrich-Baur Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neolexon Therapy	Device: Neolexon; Application (Neolexon) on Tablet. Same frequency & intensity as in the other interventions; Other: Self training; Same frequency & intensity as in the other interventions
Active Comparator: Standard logopedic therapy	Other: Self training; Same frequency & intensity as in the other interventions; Other: Speech therapy; standard logopedic speech therapy. Same frequency & intensity as in the other interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Modified Rankin Scale (mRS): It is a Scoring System , which objectively quantifies disability after stroke in daily activities.; Scoring http://www.strokecenter.org/wp-content/uploads/2011/08/modified_rankin.pdf; 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.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. 2. 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	3 months
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"	3 months

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Katharina Feil, MD, Ludwig Maximlians University (LMU) Munich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Aphasia; Speech therapy; Computer based
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: 19-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No