Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia

Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS with intensive language therapy as a way of enhancing language outcomes in aphasia

Study Overview

• Status: Completed
• Conditions: Aphasia
• Intervention / Treatment: Device: transcranial direct current stimulation

Detailed Description

Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS supplementing clinically determined intensive language therapy as a way of enhancing language outcomes in aphasia. Eligible clients enrolled in the University of Michigan Aphasia Program (UMAP) will be invited to participate in the study. Clients will receive 20 minutes of tDCS every day along with their usual treatment protocol. Pre and post testing will be completed to assess for improvement in language functioning. This is a feasibility and proof of concept study to determine if a randomized control trial should be pursued

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48194
      • University Center for Language and Literacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of aphasia
• Enrolled in intensive therapy program at the University of Michigan Aphasia Program.
• Ability to understand and give consent to treatment.

Exclusion Criteria:

• No metal implants or surgical devices
• History of seizures
• History of significant cognitive or psychiatric disturbance
• Participant cannot be pregnant at the time of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transcranial Direct Current Stimulation; tDCS will be given to all qualified patients with aphasia.	Device: transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Controlled Oral Word Fluency	This test assesses the number of words that can be generated in one minute that begin with certain letters. The total number of words generated for three letters is derived. Higher scores represent better performance. Changes in word fluency were calculated as follows: number of words generated post tDCS minus number of words generated pre tDCS	baseline and 4 weeks
Change in Boston Naming Score	This test assesses confrontational naming ability to 60 line drawings. Scores range from 0-60 with higher scores representing better performance. Outcome was derived as followed : Picture naming score post tDCS minus picture naming score pre tDCS	baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Western Aphasia Quotient Score	severity of aphasia is measured by the Western Aphasia Battery Revised. The Aphasia Quotient (AQ) score ranges from 0-100, with 100 being a perfect score. Change in the AQ was derived as follows : AQ post tDCS minus AQ pre tDCS	baseline and 4 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Carol Persad, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: HUM00108213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No