Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation

Sham Stimulation

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Stroke, Transcranial Direct Current Stimulation, Neuroplasticity

Eligibility Criteria

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

Inclusion Criteria:

Age 18 or older
Aphasia due to left hemisphere stroke diagnosed by a physician or speech-language pathologist

Exclusion Criteria:

Skull defect at or near the site of tDCS delivery
History of a significant stroke or traumatic brain injury other than the event that caused the aphasia
History of other brain conditions that could impact interpretation of results (such as multiple sclerosis, brain tumor, encephalitis, premorbid dementia)
Presence of implanted electrical or metallic devices in the head or body (except titanium; e.g. cochlear implants, implanted shunts with metal parts, deep brain stimulators, pacemakers, defibrillators)
Presence of ferrous metal in the head (e.g. shrapnel)
History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common selective serotonin reuptake inhibitor antidepressants)
Pregnancy
Severe comprehension deficits

Additional Exclusion Criteria for the optional MRI portion of the study:

Presence of metal in the body (except titanium)
Claustrophobia

Sites / Locations

MedStar National Rehabilitation Hospital
Georgetown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Transcranial Direct Current Stimulation

Sham Stimulation

Arm Description

TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period

Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Outcomes

Primary Outcome Measures

Western Aphasia Battery - Revised: Naming and Word Finding Score

This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.

Secondary Outcome Measures

Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient

The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).

Philadelphia Naming Test (PNT)

A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.

Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)

Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with "as able as before the stroke" written on the right side of the line and "not at all as able" on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates "as able as before the stroke" and 0 indicates "not at all as able".

Cognitive-Linguistic Quick Test (CLQT)

The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0

Reading Assessments

A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.

Motricity Index

An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.

Full Information

NCT ID

NCT01709383

First Posted

August 28, 2012

Last Updated

June 6, 2017

Sponsor

Georgetown University

Collaborators

Medstar Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01709383

Brief Title

Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia

Official Title

Can Enhancing Left Lateralization Using Transcranial Direct Current Stimulation Improve Recovery From Post-Stroke Aphasia?

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Georgetown University

Collaborators

Medstar Health Research Institute

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This study tests whether weak electrical stimulation of the brain is effective in improving language or reading difficulties occurring after a brain injury or stroke.

Detailed Description

This study tests whether aphasia or alexia, language and reading disorders occurring after traumatic brain injury or stroke, can be improved using transcranial direct current stimulation (tDCS). tDCS is a non-invasive technique that applies a small amount of direct electrical current to the brain in order to temporarily alter brain processing. Adults with aphasia/alexia resulting from stroke or traumatic brain injury will undergo baseline behavioral testing of various language and cognitive functions. Subjects who are willing to undergo MRI evaluation will also be scanned. They will then receive five days of either real or sham tDCS with standardized speech-language therapy, under a double-blind randomized placebo-controlled design. Behavioral assessments, and MRIs for those participating in the MRI portion of the study, will be performed again at multiple time points after completing tDCS to assess for changes in these measures.

6. Conditions and Keywords

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

Aphasia

Keywords

Aphasia, Stroke, Transcranial Direct Current Stimulation, Neuroplasticity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcranial Direct Current Stimulation

Arm Type

Active Comparator

Arm Description

TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period

Arm Title

Sham Stimulation

Arm Type

Sham Comparator

Arm Description

Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation

Intervention Description

The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Intervention Type

Device

Intervention Name(s)

Sham Stimulation

Intervention Description

The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.

Primary Outcome Measure Information:

Title

Western Aphasia Battery - Revised: Naming and Word Finding Score

Description

This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.

Time Frame

Change from baseline to one day after treatment

Secondary Outcome Measure Information:

Title

Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient

Description

The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).

Time Frame

Change from baseline to 1 day after treatment

Title

Philadelphia Naming Test (PNT)

Description

A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.

Time Frame

1 day after treatment

Title

Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)

Description

Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with "as able as before the stroke" written on the right side of the line and "not at all as able" on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates "as able as before the stroke" and 0 indicates "not at all as able".

Time Frame

3 weeks post-treatment

Title

Cognitive-Linguistic Quick Test (CLQT)

Description

The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0

Time Frame

Change from baseline to 1 day after treatment

Title

Reading Assessments

Description

A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.

Time Frame

Change from baseline to 1 day after treatment

Title

Motricity Index

Description

An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.

Time Frame

Change from baseline to 1 day after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age 18 or older Aphasia due to left hemisphere stroke diagnosed by a physician or speech-language pathologist Exclusion Criteria: Skull defect at or near the site of tDCS delivery History of a significant stroke or traumatic brain injury other than the event that caused the aphasia History of other brain conditions that could impact interpretation of results (such as multiple sclerosis, brain tumor, encephalitis, premorbid dementia) Presence of implanted electrical or metallic devices in the head or body (except titanium; e.g. cochlear implants, implanted shunts with metal parts, deep brain stimulators, pacemakers, defibrillators) Presence of ferrous metal in the head (e.g. shrapnel) History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common selective serotonin reuptake inhibitor antidepressants) Pregnancy Severe comprehension deficits Additional Exclusion Criteria for the optional MRI portion of the study: Presence of metal in the body (except titanium) Claustrophobia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Turkeltaub, M.D., Ph.D.

Organizational Affiliation

Georgetown University and MedStar National Rehabilitation Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

MedStar National Rehabilitation Hospital

City

Washington, D.C.

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Georgetown University

City

Washington, D.C.

State/Province

District of Columbia

ZIP/Postal Code

20057

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

20040569

Citation

Zaghi S, Acar M, Hultgren B, Boggio PS, Fregni F. Noninvasive brain stimulation with low-intensity electrical currents: putative mechanisms of action for direct and alternating current stimulation. Neuroscientist. 2010 Jun;16(3):285-307. doi: 10.1177/1073858409336227. Epub 2009 Dec 29.

Results Reference

result

PubMed Identifier

21842404

Citation

Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.

Results Reference

result

PubMed Identifier

21233468

Citation

Fridriksson J, Richardson JD, Baker JM, Rorden C. Transcranial direct current stimulation improves naming reaction time in fluent aphasia: a double-blind, sham-controlled study. Stroke. 2011 Mar;42(3):819-21. doi: 10.1161/STROKEAHA.110.600288. Epub 2011 Jan 13.

Results Reference

result

Aphasia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial