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

NCT02540109 | Completed Phase 2 DMC

• 2 other identifiers: SMI092144-P21R44NS092144
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Aphasia

Keywords

Stroke; Anomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine alternate outcome measures

  4 weeks and 6 months follow up

Study Arms (2)

High-Definition tDCS (Active)

EXPERIMENTAL

Device: HD-tDCS (Soterix Medical, Active)

High-Definition tDCS (Sham)

EXPERIMENTAL

Device: HD-tDCS (Soterix Medical, Sham)

Interventions

HD-tDCS (Soterix Medical, Active) DEVICE

Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.

Also known as: Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargets

High-Definition tDCS (Active)

HD-tDCS (Soterix Medical, Sham) DEVICE

Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.

Also known as: Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargets

High-Definition tDCS (Sham)

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.)

Washington D.C., District of Columbia, 20057, United States

Location

University of North Carolina School of Medicine (Adam Jacks, Ph.D.)

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

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

MeSH Terms

Conditions

Stroke; Anomia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abhishek Datta, Ph.D

  Soterix Medical Inc.

  STUDY CHAIR

• Lucas C Parra, Ph.D

  City University of New York - CCNY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 3, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

US (2)