Trial document




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  DRKS00011116

Trial Description

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Title

Effects of transcranial direct current stimulation (tDCS) on patients with apraxia of speech: a combined tDCS-fMRI study

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Trial Acronym

SPRAX-tDCS

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URL of the Trial

http://www.neuroscience-aachen.de

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Brief Summary in Lay Language

In this trial we will examine whether patients suffering from apraxia of speech show additional benefit from direct current stimulation in addition to conventional speech and language therapy.

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Brief Summary in Scientific Language

It is the aim of the study to determine the effectiveness of tDCS in a cohort of patients suffering from chronic aphasia and to elucidate corresponding neuronal activity by means of structural and functional MRI. In addition to conventional speech and language therapy, a group of 40 patients will receive 30 minutes of additional therapy focusing on apraxia of speech, complemented by daily bihemispheric tDCS over F5-F7 (left: anodal stimulation, right: cathodal stimulation) with 2MA over a period of 20 minutes) over a period of two weeks. In order to control for placebo effects, half of the patients will receive "verum" (i.e., actual current) stimulation, while the other half, matched for age, sex and disease severity as well as for time after stroke, will receive "sham" stimulation only. This will be done in a double-blind fashion. Primary endpoint will be improvements in the verum cohort in the Hierarchical Word Lists compared to the sham cohort. Secondary endpoints include changes in neuronal markers derived from fMRI and structural MRI.

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Organizational Data

  •   DRKS00011116
  •   2017/08/31
  •   [---]*
  •   yes
  •   Approved
  •   147/16, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   R47.1 -  Dysarthrie und Anarthrie
  •   R47.0 -  Dysphasie und Aphasie
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Interventions/Observational Groups

  •   Patients will receive actual transcranial direct current stimulation, with the cathode placed over F7-F5 right and the anode placed over F7-F5 left, employing 20 minutes of 2mA, in addition to conventional speech and language therapy (SLT), every day for 2 weeks.
  •   Patients will receive sham transcranial direct current stimulation only, with the cathode placed over F7-F5 right and the anode placed over F7-F5 left. The current will be switched off after 20 seconds, rendering the intervention without effect, every day for 2 weeks.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Improvements in language abilities in the VERUM-cohort as opposed to the SHAM-cohort. Improvements will be measured using the Hierarchical Word Lists in the week prior the first week of therapy and the week following the last therapeutic session (week 3).

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Secondary Outcome

1) Improvements in other linguistic domains in the VERUM-cohort as opposed to the sham-cohort. These endpoints will be assessed using the AAT ((Aachener Aphasie Test), a novel test measuring apraxia of speech (AoS) and a formal test of diadochokinesis. Test points will be the week prior and the week after therapy (week 3).
2) Quality of life; the ALQUI will be applied in the week prior to therapy and 20 weeks after therapy.
3) Neuronal marker correlating with linguistic improvements. Structural (T1, DTI) and functional MRI (task based: spontaneous speech, diadochokinesis; resting state fMRI) will be employed prior to therapy and in the week after therapy (week 3).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/08/04
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Etiology of aphasia: first-ever ischemic stroke of the left cerebral hemisphere; chronic phase of the disease: >6 months post-onset; presence of apraxia of speech as diagnosed by speech and language therapist as well as neurologist; right-handed; German as native language

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Exclusion Criteria

Severe aphasia with language comprehension <25 in the relevant subtest of the AAT; left-handedness; contraindications for tDCS (e.g., epilepsy); contraindications for MRI; no/reduced compliance; participation in clinical trial in the last 3 months.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik RWTH Aachen, Klinik für Neurologie
    • Mr.  Dr. med.  Cornelius J.  Werner 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Aphasiestation, Klinik für Neurologie, Uniklinik RWTH Aachen
    • Ms.  MSc.  Jennifer  Kelke 
    • Pauwelsstrße 30
    • 52074  Aachen
    • Germany
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    • Uniklinik RWTH Aachen, Klinik für Neurologie
    • Mr.  Dr. med.  Cornelius J.  Werner 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Uniklinik RWTH Aachen, Klinik für Neurologie
    • Mr.  Dr. med.  Cornelius J.  Werner 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik RWTH Aachen, Klinik für Neurologie
    • Mr.  Dr. med.  Cornelius J.  Werner 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.