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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03510182
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Actual Duration (Months): 38.4
• Patients Per Site Per Month: 0.7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Aphasia	Device: transcranial direct current stimulation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All eligible participants with aphasia will receive the tDCSAll eligible participants with aphasia will receive the tDCS
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia
• Actual Study Start Date: Dec 15, 2016
• Actual Primary Completion Date: Feb 26, 2020
• Actual Study Completion Date: Feb 26, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Center for Language and Literacy	Ann Arbor	Michigan	United States	48194

Sponsors and Collaborators

• University of Michigan

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 10, 2018

More Information

Publications

None provided.

• Responsible Party: Carol Persad, Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT03510182
• Other Study ID Numbers: HUM00108213
• First Posted: Apr 27, 2018
• Last Update Posted: Sep 20, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Aphasia

Study Results

Participant Flow

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Period Title: Overall Study
STARTED	25
COMPLETED	23
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Overall Participants	23
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35 (11.7)
Sex: Female, Male (Count of Participants)
Female	5 21.7%
Male	18 78.3%
Race and Ethnicity Not Collected (Count of Participants)
Boston Naming Test (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.94 (5.97)
Controlled Oral Word Fluency (number of words) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of words]	14.74 (10.27)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

23 of the participants completed the study

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Measure Participants	23
Mean (Standard Deviation) [number of words]	3.1 (4.89)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

23 of the 25 subjects completed the study and their data are analyzed here

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Measure Participants	23
Mean (Standard Deviation) [score]	1.25 (3.96)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

23 subjects completed the study and their data were analyzed

Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Measure Participants	23
Mean (Standard Deviation) [aphasia quotient score]	8.57 (6.37)

Adverse Events

Time Frame	30 days
Arm/Group Title	Transcranial Direct Current Stimulation
Arm/Group Description	tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
All Cause Mortality
	Transcranial Direct Current Stimulation
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	Transcranial Direct Current Stimulation
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Transcranial Direct Current Stimulation
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.