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Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study

Primary Purpose

Chronic Aphasia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HD-tDCS (Soterix Medical, Active)
HD-tDCS (Soterix Medical, Sham)
Sponsored by
Soterix Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Aphasia focused on measuring Stroke, Anomia

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • one-time ischemic stroke in the left hemisphere
  • greater than 6-months post-stroke onset
  • between 25 and 75 years of age
  • aphasia diagnosis (as determined by pre-treatment language-based testing)
  • right-handed (before the stroke)
  • native speaker of English
  • ability to provide informed written or verbal consent

Exclusion Criteria:

  • clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
  • factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
  • prior history of epileptic or unprovoked seizures occurring during the previous 12 months.
  • Presence of Metal implants of claustrophobia (not able to undergo MRI)
  • Pregnancy
  • Presence of any other neurological disease than stroke
  • Childhood history of speech, language, hearing, or intellectual impairment

Sites / Locations

  • Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.)Recruiting
  • University of North Carolina School of Medicine (Adam Jacks, Ph.D.)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High-Definition tDCS (Active)

High-Definition tDCS (Sham)

Arm Description

Outcomes

Primary Outcome Measures

Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke
The primary outcome measures the ability of subjects to name objects in a standardized naming task. Prior to treatment MRI and fMRI are acquired to inform the individualized current flow models for optimal targeting.

Secondary Outcome Measures

Determine alternate outcome measures
Determine alternate outcome measures, such as naming performance at 4 weeks and 6 months after treatment and improvements in more general discourse performance. An additional secondary exploratory objective is to perform a screening comparison of HD-tDCS with historical data on conventional non-targeted tDCS using sponge electrodes.

Full Information

First Posted
August 31, 2015
Last Updated
April 2, 2019
Sponsor
Soterix Medical
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Georgetown University, University of North Carolina, Chapel Hill, The City College of New York, Medstar Health Research Institute, University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02540109
Brief Title
Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study
Official Title
Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soterix Medical
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Georgetown University, University of North Carolina, Chapel Hill, The City College of New York, Medstar Health Research Institute, University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Aphasia
Keywords
Stroke, Anomia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-Definition tDCS (Active)
Arm Type
Experimental
Arm Title
High-Definition tDCS (Sham)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HD-tDCS (Soterix Medical, Active)
Other Intervention Name(s)
Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargets
Intervention Description
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
Intervention Type
Device
Intervention Name(s)
HD-tDCS (Soterix Medical, Sham)
Other Intervention Name(s)
Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargets
Intervention Description
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
Primary Outcome Measure Information:
Title
Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke
Description
The primary outcome measures the ability of subjects to name objects in a standardized naming task. Prior to treatment MRI and fMRI are acquired to inform the individualized current flow models for optimal targeting.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Determine alternate outcome measures
Description
Determine alternate outcome measures, such as naming performance at 4 weeks and 6 months after treatment and improvements in more general discourse performance. An additional secondary exploratory objective is to perform a screening comparison of HD-tDCS with historical data on conventional non-targeted tDCS using sponge electrodes.
Time Frame
4 weeks and 6 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: one-time ischemic stroke in the left hemisphere greater than 6-months post-stroke onset between 25 and 75 years of age aphasia diagnosis (as determined by pre-treatment language-based testing) right-handed (before the stroke) native speaker of English ability to provide informed written or verbal consent Exclusion Criteria: clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery) prior history of epileptic or unprovoked seizures occurring during the previous 12 months. Presence of Metal implants of claustrophobia (not able to undergo MRI) Pregnancy Presence of any other neurological disease than stroke Childhood history of speech, language, hearing, or intellectual impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abhishek Datta, Ph.D
Phone
888-990-8327
Email
contact@soterixmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas C Parra, Ph.D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhishek Datta, Ph.D
Organizational Affiliation
Soterix Medical Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lucas C Parra, Ph.D
Organizational Affiliation
City University of New York - CCNY
Official's Role
Study Chair
Facility Information:
Facility Name
Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth H Lacey, Ph.D.
Phone
202-877-1124
Email
ehl4@georgetown.edu
First Name & Middle Initial & Last Name & Degree
Maryam Ghaleh, Ph.D.
Phone
202-687-5205
Email
mg1477@georgetown.edu
Facility Name
University of North Carolina School of Medicine (Adam Jacks, Ph.D.)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia Rodriguez
Phone
919-843-3699
Email
marciar@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Tyson Harmon
Phone
919-843-3699
Email
tyson_harmon@med.unc.edu

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25547776
Description
Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia.

Learn more about this trial

Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study

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