NCT01924702

Brief Summary

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

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
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

Longer than P75 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, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

4.9 years

First QC Date

August 14, 2013

Last Update Submit

February 3, 2015

Conditions

AphasiaAnomia (Word-Finding Impairment)

Outcome Measures

Primary Outcomes (1)

  • naming performance

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

Secondary Outcomes (5)

  • naming performance

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

  • Naming performance during functional magnetic resonance scanning

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

  • Naming performance during functional magnetic resonance imaging

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

  • Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)

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

  • Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)

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

Study Arms (2)

anodal tDCS

ACTIVE COMPARATOR

Intensive language therapy with anodal transcranial direct current stimulation

Behavioral: Intensive language therapyDevice: transcranial direct current stimulation

sham tDCS

SHAM COMPARATOR

Intensive language therapy with Sham-tDCS

Behavioral: Intensive language therapyDevice: transcranial direct current stimulation

Interventions

Intensive language therapyBEHAVIORAL

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

anodal tDCSsham tDCS
transcranial direct current stimulationDEVICE

1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral

anodal tDCSsham tDCS

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
  • history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity
  • dementia
  • contraindications for Magnetic Resonance Imaging or transcranial direct current stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite

Berlin, Germany

RECRUITING

MeSH Terms

Conditions

AphasiaAnomia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Agnes Floeel, Prof MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Darkow

CONTACT

004930450560395robert.darkow@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 16, 2013

Study Start

January 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

DE(1)