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

Not Applicable

Completed

• Conditions: Aphasia
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT03510182
• Lead Sponsor: University of Michigan

Brief Summary

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

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 Timeline

• Study Start: 2016-12-15
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-27
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Disposition First Submitted: 2021-02-12
• Disposition First Submitted QC: 2021-02-12
• Disposition First Posted: 2021-02-17
• Status Verified: 2021-08
• Results First Submitted: 2021-08-24
• Results First Submitted QC: 2021-08-24
• Last Update Submitted: 2021-08-24
• Results First Posted: 2021-09-20
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transcranial Direct Current Stimulation	transcranial direct current stimulation	tDCS will be given to all qualified patients with aphasia.

Primary Outcome Measures

Name	Time	Method
Change in Boston Naming Score	baseline and 4 weeks	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
Change in Controlled Oral Word Fluency	baseline and 4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Change in Western Aphasia Quotient Score	baseline and 4 weeks	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

Trial Locations

Locations (1)

University Center for Language and Literacy; 🇺🇸 Ann Arbor, Michigan, United States