NCT01922245

Brief Summary

This project will investigate the use of noninvasive brain stimulation in the form of tDCS (transcranial direct current stimulation) in conjunction with speech-language therapy, for the improvement of language production in stroke survivors with aphasia. The hypothesis is that anodal tDCS and speech-language therapy will facilitate improved outcomes compared to speech therapy alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

2.5 years

First QC Date

August 2, 2013

Last Update Submit

August 13, 2020

Conditions

Keywords

aphasiatherapystrokelanguagenamingquality of lifetDCStreatment

Outcome Measures

Primary Outcomes (1)

  • change in naming performance in singles words and sentence context

    Naming will be tested using standardized tests such at the Boston Naming Test and or the Philadelphia Naming Test. In addition, sentence probes have been created that will assess naming in the sentence context throughout the study.

    change from baseline naming performance at two weeks and four weeks post treatment

Secondary Outcomes (2)

  • change in sentence production

    change from baseline performance at two weeks and four weeks post treatment

  • change in health related quality of life

    change from baseline performance at two weeks and four weeks post treatment

Study Arms (1)

anodal tDCS

EXPERIMENTAL

Soterix 1x1 device: anodal tDCS administered to the left hemisphere

Device: Soterix 1x1 tDCS

Interventions

Anodal and sham tDCS will be administered. All of the participants will also receive behavioral speech-language therapy.

anodal tDCS

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter College Brookdale Campus

New York, New York, 10010, United States

Location

Related Publications (3)

  • Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.

    PMID: 20395612BACKGROUND
  • Fiori V, Cipollari S, Di Paola M, Razzano C, Caltagirone C, Marangolo P. tDCS stimulation segregates words in the brain: evidence from aphasia. Front Hum Neurosci. 2013 Jun 14;7:269. doi: 10.3389/fnhum.2013.00269. eCollection 2013.

    PMID: 23785323BACKGROUND
  • Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients after stroke. Cochrane Database Syst Rev. 2013 Jun 25;(6):CD009760. doi: 10.1002/14651858.CD009760.pub2.

MeSH Terms

Conditions

AphasiaStrokeLanguage

Condition Hierarchy (Ancestors)

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

Study Officials

  • Elizabeth E Galletta, PhD

    Hunter College/City University of NY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 14, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations