search
Back to results

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

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Center for Language and Literacy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transcranial Direct Current Stimulation

Arm Description

tDCS will be given to all qualified patients with aphasia.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
April 5, 2018
Last Updated
August 24, 2021
Sponsor
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT03510182
Brief Title
Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia
Official Title
Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All eligible participants with aphasia will receive the tDCS
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
tDCS will be given to all qualified patients with aphasia.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Change in Controlled Oral Word Fluency
Description
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
Time Frame
baseline and 4 weeks
Title
Change in Boston Naming Score
Description
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
Time Frame
baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in Western Aphasia Quotient Score
Description
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
Time Frame
baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Persad, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Center for Language and Literacy
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48194
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs