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

Chronic Aphasia Clinical Trial

Official title:

Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540109
• Other study ID #: SMI092144-P2
• Secondary ID: 1R44NS092144
• Status: Completed
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: September 2019

Study information

• Verified date: December 2023
• Source: Soterix Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Chronic Aphasia

Intervention

Device:
• HD-tDCS (Soterix Medical, Active)
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
• HD-tDCS (Soterix Medical, Sham)
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.

Locations

Country	Name	City	State
United States	University of North Carolina School of Medicine (Adam Jacks, Ph.D.)	Chapel Hill	North Carolina
United States	Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.)	Washington	District of Columbia

Sponsors (7)

Lead Sponsor	Collaborator
Soterix Medical	Georgetown University, Medstar Health Research Institute, National Institute of Neurological Disorders and Stroke (NINDS), The City College of New York, University of North Carolina, Chapel Hill, University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks
Secondary	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.	4 weeks and 6 months follow up

External Links

•   Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia.