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Status unknownNCT01221779CATSUpdated Aug 27, 2013

Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation

A Phase 2 interventional study of Intensive language therapy and Intensive language therapy in Post-Stroke Chronic Aphasia and Anomia (Word-retrieval Impairment), sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-08-27.

Sponsored by Charite University, Berlin, Germany · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the out of intensive language therapy in chronic aphasia

Read the detailed description

Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. High-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. However, despite its general effectiveness, treatment effect sizes are only low to moderate. Thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. Moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. This is the prerequisite to improve existing and/or develop new treatment paradigms.

Thus, in the present project we aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. We will be using anodal transcranial direct current stimulation (atDCS) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. Specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atDCS. Treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. We will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.

02

Conditions studied

  • Post-Stroke Chronic Aphasia
  • Anomia (Word-retrieval Impairment)

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Keywords

  • Intensive language therapy
  • Anomia
  • Magnetic Resonance Imaging
03

In context

Anomia

47 studies on the registry are indexed under Anomia; 9 are open to participants now.

This study's planned enrollment of 40 is above the median of 24 across 43 interventional studies indexed under Anomia.

Browse Anomia studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • right-handedness
  • single first time left-hemisphere stroke
  • fluent- or non-fluent chronic aphasia (more than six months post-stroke)
  • anomia (PR>10 and PR\<60 Aachen Aphasia Naming Subtest)
  • native German Speaker

Exclusion criteria

Exclusion Criteria:

  • more than one stroke
  • alcoholism, severe psychiatric conditions, other neurological conditions
  • other non-treated medical problems, severe microangiopathy
  • pregnancy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Placebo comparator
    sham tDCS

    Behavioral: Intensive language therapy

  • Experimental
    anodal tDCS

    Behavioral: Intensive language therapy

Interventions

  • BehavioralIntensive language therapy

    2 weeks of daily computerized naming training, daily, 3 hours

  • BehavioralIntensive language therapy

    2 weeks of daily computerized naming training, daily, 3 hours

06

What researchers measure

Primary outcomes

  1. Boston Naming Test

    Time frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)

Secondary outcomes

  1. Boston Naming Test

    The follow-up will be administered to assess the stability of the treatment gains

    Time frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)

  2. Naming performance during functional magnetic resonance scanning

    assessed during overt picture naming task

    Time frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)

  3. Naming performance during functional magnetic resonance imaging

    assessed during overt picture naming task

    Time frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)

07

Study locations

1 of 1 sites recruiting
  • Charite, University Medicine, Dept. of Neurology
    Berlin, Germany
    Recruiting
    • Marcus Meinzer, PhD · Principal investigator
    • Agnes Flöel, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01221779
Collaborators
German Federal Ministry of Education and Research
Responsible party
Marcus Meinzer (Creutzfeldt Fellow, Charite University, Berlin, Germany) — Principal investigator
First posted
Oct 15, 2010
Start date
Jan 2011
Primary completion
Aug 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Aug 27, 2013

Study contacts

Marcus Meinzer, PhD
Contact
marcus.meinzer@charite.de
+49-(0)30-450-560 ext. 140
Agnes Flöel, MD
Contact
agnes.floeel@charite.de
+49-(0)30-450-560 ext. 284
Marcus Meinzer, PhD
principal investigator · Charite, University Medicine, Neurology
Agnes Flöel, MD
study director · Charite, University Medicine, Neurology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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