StrokeSLISSENCT02674490
Stimulating Language in Subacute StrokE
A study testing A-tDCS (1 mA) and SALT in people with Stroke, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators will study the effects of transcranial direct current (tDCS) stimulation during language therapy for naming in individuals with aphasia in the acute and subacute post stroke period. Naming difficulties are a persistent and common symptom in aphasia after left-hemisphere (LH) stroke. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- A-tDCS (1 mA) and SALT
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2016to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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).
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) Plus Language Therapy for Naming in Subacute Left Hemisphere Stroke
The investigators will study the effects of transcranial direct current (tDCS) stimulation during language therapy for naming in individuals with aphasia in the acute and subacute post stroke period. Naming difficulties are a persistent and common symptom in aphasia after left-hemisphere (LH) stroke. Behavioral therapy (speech and language therapy; SALT) is the mainstay treatment for post stroke aphasia. Transcranial direct cortical stimulation (tDCS) is a promising adjunct to traditional SALT. tDCS is a safe, non-invasive, non-painful electrical stimulation of the brain which modulates cortical excitability by application of weak electrical currents in the form of direct current brain polarization. It is usually administered via saline-soaked surface sponge electrodes attached to the scalp and connected to a direct current stimulator with low intensities. Most studies are conducted in the chronic phase after stroke. Because neuroplasticity is greatest early after stroke, there is reason to believe tDCS might be most effective in the acute-subacute period. However, only two studies have evaluated tDCS paired with language therapy in group studies of acute to subacute aphasic stroke patients and only one of these was sham-controlled. Furthermore, no studies (of which we are aware) have combined tDCS with therapy to facilitate naming in post stroke aphasia, as shown to be effective in studies of chronic stroke. In this study, the investigators will evaluate whether tDCS combined with SALT improves naming in individuals with aphasia in the acute and subacute post stroke period, more than SALT alone in a randomized, double-blind, sham-controlled trial. The investigators will test the hypothesis that anodal tDCS (A-tDCS) over a targeted region and computer-delivered SALT is associated with greater gains in accuracy in naming pictures, compared to sham combined with the same computer-delivered SALT in post stroke aphasia.
Read the detailed description
After informed consent is received, a neurological examination will be performed and multiple screening assessments will be conducted including a tDCS and MRI safety screening. If the participant passes the initial screening portion, speech and language diagnostic testing will be conducted during the same visit (Visit 1). During the next visit (Visit 2), participants will undergo a second baseline assessment of naming ability and assessment of connected speech. On that visit, participants who have no contraindication for MRI (and agree to have MRI) will be randomized to (1) functional magnetic resonance (fMRI) electrode placement or (2) structural electrode placement. All participants who have no contraindication will have structural and resting state functional connectivity MRI (rsfcMRI). Those randomized to fMRI electrode placement will also participate in the naming paradigm during the MRI. The third visit will include electrode positioning and tDCS treatment administration. Participants will receive 15 sessions (Visits 3-17) of tDCS + SALT administration. At the beginning of Visit 3, eligible participants will be randomized to receive either A-tDCS (1 milli amp (mA)) or sham-tDCS (placebo) for 15 sessions (20-minutes per each 45-minute behavioral treatment session) over the course of three weeks. A computer-delivered naming treatment will be coupled with the stimulation. The computer-delivered treatment task will be 45-minutes in total length, so that it will commence at the same time as the tDCS administration and continue for another 25-minutes after the tDCS has ceased. To assess cardiovascular arousal, blood pressure and heart rate will be measured before and after each session. Additionally, discomfort ratings will be recorded following the end of each session using the Wong-Baker FACES Pain Rating Scale and a weekly neurological exam will be administered by a neurologist. Neither the participant nor the clinician monitoring and setting up the treatment will have knowledge of the treatment condition (A-tDCS versus sham). Utilizing a computerized picture naming assessment, all participants will be assessed at several different time points throughout the experiment: twice immediately before and twice the week immediately following the fifteenth and final treatment session; twice at five weeks follow-up after the end of treatment; and twice at 20 weeks after the end of treatment. Participants who agree to participate in the MRI portion of the study (and have none of the additional exclusion criteria for MRI) will have structural and rsfcMRI at Visit 2, following the 15th treatment session (Week 1 after the end of treatment), and at 5 weeks after the end of treatment.
- Conditions
- Stroke
- Being tested
- A-tDCS (1 mA), SALT, Sham
- Keywords
- aphasia, language
- Medical subject headings
- Stroke, Aphasia, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-tDCS (1 mA)Device
Also called Anodal transcranial direct current stimulation
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.
SALTBehavioural
Also called Speech and Language Treatment
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.
ShamDevice
Also called Sham-tDCS
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.
| Study group | Role | What they receive |
|---|---|---|
| A-tDCS & SALT | Experimental | 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 . Receives: Device: A-tDCS (1 mA); Behavioral: SALT |
| Sham-tDCS & SALT | Sham comparator | 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. Receives: Behavioral: SALT; Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test (PNT)) Pre-treatment to 1 Week Post-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.
Measured: 2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatment
Secondary outcomes (11)
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 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.
Measured: 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
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.
Measured: Immediately before and within 1 week after treatment
Change in Efficiency of Picture Description Pre-treatment to 1 Week Post-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.
Measured: Immediately before and within 1 week after treatment
Change in Content of Picture Description Pre-treatment to 5 Weeks Post-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.
Measured: Immediately before and at 5 weeks after treatment
Change in Efficiency of Picture Description Pre-treatment to 5 Weeks Post-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.
Measured: Immediately before and at 5 weeks after treatment
Change in Stroke Impact Scale (SIS) Pre-treatment to Post-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.
Measured: Immediately before and within 1 week after treatment
Change in Stroke Impact Scale (SIS) Pre-treatment to 5 Weeks Post-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.
Measured: Immediately before and 5 weeks after treatment
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 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.
Measured: 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
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.
Measured: Immediately before and at 20 weeks after treatment
Change in the Efficiency of Picture Description Pre-treatment to 20 Weeks Post-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.
Measured: Immediately before and at 20 weeks after treatment
Change in Stroke Impact Scale (SIS) Pre-treatment to 20 Weeks Post-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.
Measured: Immediately before and 20 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start15 Jun 2016
- Primary completion12 Nov 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Argye B Hillis-Trupe, MD, MA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674490
- Sponsor's protocol ID
- IRB00089018
- Acronym
- SLISSE
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2016
- Last updated
- 10 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Upon completion of the projects and dissemination of primary study results, the analysis data files will be made available to the public, along with the final version of the study protocol, the data dictionary, and brief instructions ("Read me" file). The public use data files and the accompanying documents will be made available through the National Technical Information Service (NTIS).
Publications
Kang JS, Bunker LD, Stockbridge MD, Hillis AE. White Matter Hyperintensities as a Predictor of Aphasia Recovery. Arch Phys Med Rehabil. 2024 Jun;105(6):1089-1098. doi: 10.1016/j.apmr.2024.01.008. Epub 2024 Jan 26.
PubMed 38281579Stockbridge MD, Elm J, Teklehaimanot AA, Cassarly C, Spell LA, Fridriksson J, Hillis AE. Individual Differences in Response to Transcranial Direct Current Stimulation With Language Therapy in Subacute Stroke. Neurorehabil Neural Repair. 2023 Aug;37(8):519-529. doi: 10.1177/15459683231190642. Epub 2023 Aug 17.
PubMed 37592860Stockbridge MD, Elm J, Breining BL, Tippett DC, Sebastian R, Cassarly C, Teklehaimanot A, Spell LA, Sheppard SM, Vitti E, Ruch K, Goldberg EB, Kelly C, Keator LM, Fridriksson J, Hillis AE. Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. Stroke. 2023 Apr;54(4):912-920. doi: 10.1161/STROKEAHA.122.041557. Epub 2023 Mar 13.
PubMed 36912144
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) Plus Language Therapy for Naming in Subacute Left Hemisphere Stroke
- ClinicalTrials.gov ID
- NCT02674490
- Acronym / sponsor ID
- SLISSE / IRB00089018
- Conditions
- Stroke
- Keywords
- aphasia, language
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of South Carolina
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 30 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will study the effects of transcranial direct current (tDCS) stimulation during language therapy for naming in individuals with aphasia in the acute and subacute post stroke period. Naming difficulties are a persistent and common symptom in aphasia after left-hemisphere (LH) stroke. Behavioral therapy (speech and language therapy; SALT) is the mainstay treatment for post stroke aphasia. Transcranial direct cortical stimulation (tDCS) is a promising adjunct to traditional SALT. tDCS is a safe, non-invasive, non-painful electrical stimulation of the brain which modulates cortical excitability by application of weak electrical currents in the form of direct current brain polarization. It is usually administered via saline-soaked surface sponge electrodes attached to the scalp and connected to a direct current stimulator with low intensities. Most studies are conducted in the chronic phase after stroke. Because neuroplasticity is greatest early after stroke, there is reason to believe tDCS might be most effective in the acute-subacute period. However, only two studies have evaluated tDCS paired with language therapy in group studies of acute to subacute aphasic stroke patients and only one of these was sham-controlled. Furthermore, no studies (of which we are aware) have combined tDCS with therapy to facilitate naming in post stroke aphasia, as shown to be effective in studies of chronic stroke. In this study, the investigators will evaluate whether tDCS combined with SALT improves naming in individuals with aphasia in the acute and subacute post stroke period, more than SALT alone in a randomized, double-blind, sham-controlled trial. The investigators will test the hypothesis that anodal tDCS (A-tDCS) over a targeted region and computer-delivered SALT is associated with greater gains in accuracy in naming pictures, compared to sham combined with the same computer-delivered SALT in post stroke aphasia.
Detailed description
After informed consent is received, a neurological examination will be performed and multiple screening assessments will be conducted including a tDCS and MRI safety screening. If the participant passes the initial screening portion, speech and language diagnostic testing will be conducted during the same visit (Visit 1). During the next visit (Visit 2), participants will undergo a second baseline assessment of naming ability and assessment of connected speech. On that visit, participants who have no contraindication for MRI (and agree to have MRI) will be randomized to (1) functional magnetic resonance (fMRI) electrode placement or (2) structural electrode placement. All participants who have no contraindication will have structural and resting state functional connectivity MRI (rsfcMRI). Those randomized to fMRI electrode placement will also participate in the naming paradigm during the MRI. The third visit will include electrode positioning and tDCS treatment administration. Participants will receive 15 sessions (Visits 3-17) of tDCS + SALT administration. At the beginning of Visit 3, eligible participants will be randomized to receive either A-tDCS (1 milli amp (mA)) or sham-tDCS (placebo) for 15 sessions (20-minutes per each 45-minute behavioral treatment session) over the course of three weeks. A computer-delivered naming treatment will be coupled with the stimulation. The computer-delivered treatment task will be 45-minutes in total length, so that it will commence at the same time as the tDCS administration and continue for another 25-minutes after the tDCS has ceased. To assess cardiovascular arousal, blood pressure and heart rate will be measured before and after each session. Additionally, discomfort ratings will be recorded following the end of each session using the Wong-Baker FACES Pain Rating Scale and a weekly neurological exam will be administered by a neurologist. Neither the participant nor the clinician monitoring and setting up the treatment will have knowledge of the treatment condition (A-tDCS versus sham). Utilizing a computerized picture naming assessment, all participants will be assessed at several different time points throughout the experiment: twice immediately before and twice the week immediately following the fifteenth and final treatment session; twice at five weeks follow-up after the end of treatment; and twice at 20 weeks after the end of treatment. Participants who agree to participate in the MRI portion of the study (and have none of the additional exclusion criteria for MRI) will have structural and rsfcMRI at Visit 2, following the 15th treatment session (Week 1 after the end of treatment), and at 5 weeks after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-tDCS & SALT | Experimental | Device: A-tDCS (1 mA), Behavioral: SALTA-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 . |
| Sham-tDCS & SALT | Sham comparator | Behavioral: SALT, Device: ShamSham-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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-tDCS (1 mA)Also: Anodal transcranial direct current stimulation1 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. | Device | A-tDCS & SALT |
| SALTAlso: Speech and Language TreatmentComputer-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. | Behavioural | A-tDCS & SALT, Sham-tDCS & SALT |
| ShamAlso: Sham-tDCS1 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. | Device | Sham-tDCS & SALT |
Primary outcome
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.
11 secondary outcomes
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.
Change in Content of Picture Description Pre-treatment to 1 Week Post-treatment
Time frame: Immediately before and within 1 week after treatment
Change in Efficiency of Picture Description Pre-treatment to 1 Week Post-treatment
Time frame: Immediately before and within 1 week after treatment
Change in Content of Picture Description Pre-treatment to 5 Weeks Post-treatment
Time frame: 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
Change in Stroke Impact Scale (SIS) Pre-treatment to Post-treatment
Time frame: 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
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.
Change in Content of Picture Description Pre-treatment to 20-weeks Post-treatment
Time frame: 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
Change in Stroke Impact Scale (SIS) Pre-treatment to 20 Weeks Post-treatment
Time frame: Immediately before and 20 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38281579Kang JS, Bunker LD, Stockbridge MD, Hillis AE. White Matter Hyperintensities as a Predictor of Aphasia Recovery. Arch Phys Med Rehabil. 2024 Jun;105(6):1089-1098. doi: 10.1016/j.apmr.2024.01.008. Epub 2024 Jan 26.
- Derived from this study: PubMed 37592860Stockbridge MD, Elm J, Teklehaimanot AA, Cassarly C, Spell LA, Fridriksson J, Hillis AE. Individual Differences in Response to Transcranial Direct Current Stimulation With Language Therapy in Subacute Stroke. Neurorehabil Neural Repair. 2023 Aug;37(8):519-529. doi: 10.1177/15459683231190642. Epub 2023 Aug 17.
- Derived from this study: PubMed 36912144Stockbridge MD, Elm J, Breining BL, Tippett DC, Sebastian R, Cassarly C, Teklehaimanot A, Spell LA, Sheppard SM, Vitti E, Ruch K, Goldberg EB, Kelly C, Keator LM, Fridriksson J, Hillis AE. Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. Stroke. 2023 Apr;54(4):912-920. doi: 10.1161/STROKEAHA.122.041557. Epub 2023 Mar 13.
- Individual participant dataSharing planned: Yes. Upon completion of the projects and dissemination of primary study results, the analysis data files will be made available to the public, along with the final version of the study protocol, the data dictionary, and brief instructions ("Read me" file). The public use data files and the accompanying documents will be made available through the National Technical Information Service (NTIS).
Related trials for Stroke
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Argye B Hillis-Trupe, MD, MA principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-tDCS (1 mA) and SALT in people with Stroke, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02674490, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.