Stimulating Language in Subacute StrokE
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/3/2019 |
| Start Date: | June 15, 2016 |
| End Date: | June 30, 2021 |
| Contact: | Argye B Hillis-Trupe, MD, MA |
| Email: | argye@jhmi.edu |
| Phone: | 410-614-2381 |
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.
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.
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) 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.
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) 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.
Inclusion Criteria:
- Participant Inclusion Criteria
Participants must satisfy the following inclusion criteria to be considered eligible for
entry into this study:
1. Participants must have sustained an acute ischemic left hemisphere stroke.
2. Participants must be fluent speakers of English by self-report.
3. Participants must be capable of giving informed consent or indicating another to
provide informed consent.
4. Participants must be age 18 or older.
5. Participants must be premorbidly right handed.
6. Participants must be within 3 months of onset of stroke.
7. Participants must have an aphasia diagnosis as confirmed by the Western Aphasia
Battery-Revised.
8. 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:
1. Previous neurological or psychiatric disease, including previous symptomatic stroke.
2. Seizures during the previous 12 months.
3. Uncorrected visual loss or hearing loss by self-report.
4. Use of medications that lower the seizure threshold (e.g., methylphenidate,
amphetamine salts).
5. Use of NMDA antagonists (e.g., memantine).
6. History of brain surgery or any metal in the head.
7. Scalp sensitivity (per participant report).
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