NCT02461355

Brief Summary

This is a randomized, crossover design trial that will compare how anodal transcranial direct current stimulation (tDCS) versus sham tDCS administered during multiple sessions of scripting therapy affects the acquisition and retention of trained scripts.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 8, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 9, 2019

Completed
Last Updated

May 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 8, 2015

Results QC Date

March 26, 2019

Last Update Submit

April 17, 2019

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • Change in Percent Correct of Trained Scripts

    From Baseline to up to 2 days post-training

  • Change in Words Per Minute of Trained Scripts

    From Baseline to up to 2 days post-training

Secondary Outcomes (2)

  • Change in Percent Correct of Trained Scripts

    Baseline to 2 weeks and 4 weeks post-training

  • Change in Words Per Minute of Trained Scripts

    Baseline to 2 weeks and 4 weeks post-training

Other Outcomes (1)

  • Change in Percent Script Words Omitted

    Baseline to immediate, 2 weeks, and 4 weeks post-training

Study Arms (2)

Anodal tDCS

EXPERIMENTAL

Anodal tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions

Behavioral: Aphasia therapyDevice: Anodal tDCS

Sham tDCS

SHAM COMPARATOR

Sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions

Behavioral: Aphasia therapyDevice: Sham tDCS

Interventions

Aphasia therapyBEHAVIORAL

Aphasia therapy using a computerized scripting program

Anodal tDCSSham tDCS
Anodal tDCSDEVICE

Anodal transcranial direct current stimulation using the Chattanooga Ionto device

Anodal tDCS
Sham tDCSDEVICE

Sham transcranial direct current stimulation using the Chattanooga Ionto device

Sham tDCS

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 21 years
  • Ischemic left hemispheric stroke verified by imaging (CT or MRI) greater than 6 months ago
  • Residual non-fluent or anomic aphasia, with Western Aphasia Battery-Revised Aphasia Quotient score \<60
  • Fluent English speaker prior to stroke
  • Right-handed prior to stroke
  • Ability to give informed consent and understand the tasks involved.

You may not qualify if:

  • History of recurrent stroke, either ischemic or hemorrhagic, in the left middle cerebral artery territory
  • Imaging unavailable
  • Large middle cerebral artery infarct involving entire inferior division (temporo-parietal) territory
  • History of dementia prior to the stroke
  • History of seizure, prior electroconvulsive therapy, deep brain stimulators, or brain surgery
  • Social and/or personal circumstances that interfere with ability to return for therapy and assessment sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adler Aphasia Center

Maywood, New Jersey, 07607, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Tomoko Kitago, MD
Organization
Burke Neurological Institute
tok7002@med.cornell.edu
914-368-3169

Study Officials

  • Tomoko Kitago, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

June 3, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 9, 2019

Results First Posted

May 9, 2019

Record last verified: 2019-04

Locations

US(1)