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

Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510182
• Other study ID #: HUM00108213
• Status: Completed
• Phase: N/A
• Start date: December 15, 2016
• Est. completion date: February 26, 2020

Study information

• Verified date: August 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia

Intervention

Device:
• transcranial direct current stimulation

Locations

Country	Name	City	State
United States	University Center for Language and Literacy	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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