- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674490
Stimulating Language in Subacute StrokE (SLISSE)
Effects of Transcranial Direct Current Stimulation (tDCS) Plus Language Therapy for Naming in Subacute Left Hemisphere Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant Inclusion Criteria
Participants must satisfy the following inclusion criteria to be considered eligible for entry into this study:
- Participants must have sustained an acute ischemic left hemisphere stroke.
- Participants must be fluent speakers of English by self-report.
- Participants must be capable of giving informed consent or indicating another to provide informed consent.
- Participants must be age 18 or older.
- Participants must be premorbidly right handed.
- Participants must be within 3 months of onset of stroke.
- Participants must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
- Participants must achieve at least 65% accuracy on screening task (comparable to treatment task) on 1 of 3 attempts
Exclusion Criteria:
- Participant Exclusion Criteria
Participants with any of the following characteristics will not be eligible for entry into this study:
- Previous neurological or psychiatric disease, including previous symptomatic stroke.
- Seizures during the previous 12 months.
- Uncorrected visual loss or hearing loss by self-report.
- Use of medications that lower the seizure threshold (e.g., methylphenidate, amphetamine salts).
- Use of N-methyl-D-aspartate (NMDA) antagonists (e.g., memantine).
- History of brain surgery or any metal in the head.
- Scalp sensitivity (per participant report).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A-tDCS & SALT
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks.
The electrical current will be administered to a pre-specified region of the brain.
The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes.
SALT will be a computer-delivered naming + picture matching task .
|
1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region.
Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation.
A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
Other Names:
Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects.
It is run on a laptop computer with headphones and 2 large response buttons.
During treatment, a picture appears on the laptop screen for 2 seconds.
Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture.
The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Other Names:
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Sham Comparator: Sham-tDCS & SALT
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks.
Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA.
SALT will be a computer delivered oral naming + picture naming task.
|
Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects.
It is run on a laptop computer with headphones and 2 large response buttons.
During treatment, a picture appears on the laptop screen for 2 seconds.
Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture.
The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Other Names:
1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region.
Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation.
Then, the current will be ramped back down to 0 mA in the sham condition.
Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test (PNT)) Pre-treatment to 1 Week Post-treatment
Time Frame: 2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatment
|
The purpose of this measure was to determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia more effectively than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. The outcome measure was the difference between the average of administrations on two consecutive days immediately before treatment and administrations on two consecutive days within 1 week after the end of treatment. |
2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 5-weeks Post-treatment
Time Frame: The PNT will be administered at baseline and at 5 weeks post treatment.
|
To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia for a greater duration than SALT alone (i.e., the sham condition).
The PNT is a 175-item picture naming test where a person earns one point per each correct answer.
Scores range from 0-175 with higher scores associated with better performance.
|
The PNT will be administered at baseline and at 5 weeks post treatment.
|
Change in Content of Picture Description Pre-treatment to 1 Week Post-treatment
Time Frame: Immediately before and within 1 week after treatment
|
The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. This measure provides a sensitive measure of content of narrative speech in all levels of aphasia. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. |
Immediately before and within 1 week after treatment
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Change in Efficiency of Picture Description Pre-treatment to 1 Week Post-treatment
Time Frame: Immediately before and within 1 week after treatment
|
The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 1-week post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task. |
Immediately before and within 1 week after treatment
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Change in Content of Picture Description Pre-treatment to 5 Weeks Post-treatment
Time Frame: Immediately before and at 5 weeks after treatment
|
The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. |
Immediately before and at 5 weeks after treatment
|
Change in Efficiency of Picture Description Pre-treatment to 5 Weeks Post-treatment
Time Frame: Immediately before and at 5 weeks after treatment
|
The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 5-weeks post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task. |
Immediately before and at 5 weeks after treatment
|
Change in Stroke Impact Scale (SIS) Pre-treatment to Post-treatment
Time Frame: Immediately before and within 1 week after treatment
|
The SIS will be administered at baseline and within 1 week after treatment to evaluate changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = [(Actual raw score - lowest possible raw score) / Possible raw score range] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery. |
Immediately before and within 1 week after treatment
|
Change in Stroke Impact Scale (SIS) Pre-treatment to 5 Weeks Post-treatment
Time Frame: Immediately before and 5 weeks after treatment
|
The SIS was administered at baseline and 5 weeks after treatment to evaluate any lasting changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = [(Actual raw score - lowest possible raw score) / Possible raw score range] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery. |
Immediately before and 5 weeks after treatment
|
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 20-weeks Post-treatment
Time Frame: The PNT will be administered at baseline and at 20 weeks post treatment.
|
To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia for a greater duration than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. |
The PNT will be administered at baseline and at 20 weeks post treatment.
|
Change in Content of Picture Description Pre-treatment to 20-weeks Post-treatment
Time Frame: Immediately before and at 20 weeks after treatment
|
The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. |
Immediately before and at 20 weeks after treatment
|
Change in the Efficiency of Picture Description Pre-treatment to 20 Weeks Post-treatment
Time Frame: Immediately before and at 20 weeks after treatment
|
The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 20-weeks post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task. |
Immediately before and at 20 weeks after treatment
|
Change in Stroke Impact Scale (SIS) Pre-treatment to 20 Weeks Post-treatment
Time Frame: Immediately before and 20 weeks after treatment
|
The SIS was administered at baseline and 20 weeks after treatment to evaluate any lasting changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = [(Actual raw score - lowest possible raw score) / Possible raw score range] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery. |
Immediately before and 20 weeks after treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Argye B Hillis-Trupe, MD, MA, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00089018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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