NCT00822068

Brief Summary

The study aims to identify if intensive language training, consisting mainly of computer-based object naming, together with electrical brain stimulation, will lead to an improvement of language functions in patients that suffer from language disturbances after a stroke.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

11 months

First QC Date

January 13, 2009

Last Update Submit

January 13, 2009

Conditions

Keywords

strokeaphasiarehabilitationtranscranial direct current stimulationintensive trainingchronic aphasia after stroke

Outcome Measures

Primary Outcomes (1)

  • Number of words correctly named after training plus tDCS

    1 year

Secondary Outcomes (1)

  • Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale

    1 year

Study Arms (3)

anodal tDCS

EXPERIMENTAL
Device: anodal tDCS

2

ACTIVE COMPARATOR

cathodal tDCS

Device: cathodal tDCS

3

PLACEBO COMPARATOR

sham stimulation

Device: sham stimulation

Interventions

anodal transcranial direct current stimulation

anodal tDCS

cathodal transcranial direct current stimulation

2

sham stimulation

3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic stroke (\> 1 year after event)
  • aphasia due to stroke with naming impairment
  • German as first language
  • first-ever stroke

You may not qualify if:

  • more than 1 stroke
  • progressive stroke
  • history of severe alcohol or drug abuse, psychiatric illnessess like severe depression, poor motivational capacity
  • dementia
  • contraindications for Magnetic Resonance Imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, University of Muenster; Department of Neurology, University of Berlin

Muenster / Berlin, NRW/Berlin-Brandenburg, 48129/10098, Germany

RECRUITING

Related Publications (1)

  • Floel A, Meinzer M, Kirstein R, Nijhof S, Deppe M, Knecht S, Breitenstein C. Short-term anomia training and electrical brain stimulation. Stroke. 2011 Jul;42(7):2065-7. doi: 10.1161/STROKEAHA.110.609032. Epub 2011 Jun 2.

MeSH Terms

Conditions

AphasiaStroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Agnes Floel, MD

    Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes Floel, MD

CONTACT

Caterina Breitenstein, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations