Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04080817
Other study ID # 19-068
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date February 1, 2020

Study information

Verified date September 2019
Source Ludwig-Maximilians - University of Munich
Contact Lars Kellert, MD
Phone 0049 (0) 89 4400 73962
Email Lars.Kellert@med.uni-muenchen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. This prospective, randomized, clinical & experimental controlled noninvasive study is intended to provide data for the therapy of an individual approach in aphasia patients.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date February 1, 2020
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Neolexon
Application (Neolexon) on Tablet. Same frequency & intensity as in the other interventions
Other:
Speech therapy
standard logopedic speech therapy. Same frequency & intensity as in the other interventions
Self training
Same frequency & intensity as in the other interventions

Locations

Country Name City State
Germany Ludwig Maximilians University (LMU) Munich, Department of Neurology with Friedrich-Baur Institute Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Epidemiologic Data age, etiology of stroke, symptoms of stroke, specific stroke therapy (i.e. intravenous thrombolysis/recanalisation), 3 months
Primary 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
Primary 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
Primary 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
Primary BI Barthel Index 3 months
Primary LAST Language Screening Test 3 months
Primary AABT Aachener Aphasie Bedside Test 3 months
Primary ACL Aphasie Check Liste 3 months
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05378035 - DOAC in Chinese Patients With Atrial Fibrillation
Completed NCT03679637 - Tablet-based Aphasia Therapy in the Acute Phase After Stroke N/A
Completed NCT03574038 - Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke N/A
Completed NCT03633422 - Evaluation of Stroke Patient Screening
Completed NCT04088578 - VNS-supplemented Motor Retraining After Stroke N/A
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Not yet recruiting NCT05534360 - Tenecteplase Treatment in Ischemic Stroke Registry
Not yet recruiting NCT04105322 - Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients N/A
Withdrawn NCT05786170 - ERILs Und SNILs Unter SOC N/A
Recruiting NCT03132558 - Contrast Induced Acute Kidney in Patients With Acute Stroke N/A
Completed NCT02893631 - Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke
Active, not recruiting NCT02274727 - Biomarker Signature of Stroke Aetiology Study: The BIOSIGNAL-Study
Completed NCT02225730 - Imaging Collaterals in Acute Stroke (iCAS)
Terminated NCT01705353 - The Role of HMGB-1 in Chronic Stroke N/A
Active, not recruiting NCT01581502 - SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF) N/A
Completed NCT01182818 - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease N/A
Completed NCT00761982 - Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment. Phase 1/Phase 2
Completed NCT00535197 - Autologous Bone Marrow Stem Cells in Ischemic Stroke. Phase 1/Phase 2
Terminated NCT00132509 - FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke Phase 2
Recruiting NCT05760326 - Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients