StrokeNCT05660304
Studying Language With Brain Stimulation in Aphasia
A study testing Cortico-cortical paired associative stimulation in people with Stroke and Aphasia, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The overall goal of this study is to evaluate whether stimulation of two brain areas alongside behavioral speech-language therapy increases connectivity to improve language functions in stroke-aphasia patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Cortico-cortical paired associative stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of non-fluent aphasia due to a single, left-hemisphere stroke
- ≧ six months post-stroke onset
- WAB-R Fluency, Grammatical Competence, and Paraphasias Score between 2-6
- 18+ years of age
- Premorbidly right-handed
- English-speaking
- Ability to participate in fMRI / TMS protocol
Who cannot join
- Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
- Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
- Surgical clips in the head or previous neurosurgery
- Any magnetic particles in the body
- Cochlear implants
- Prosthetic heart valves
Show all 14Show fewer
- Epilepsy or any other type of seizure history
- History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
- Significant other disease (heart disease, malignant tumors, mental disorders)
- Significant claustrophobia
- Ménière's disease
- Medications that increase risk of seizures, for instance antipsychotic and antidepressant medications acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
- Non-prescribed drug use, for instance recreational marijuana
- Unable to refrain from using any alcohol and nicotine products for at least 24 hours before the study Visits.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Julio Hernandez Pavon, PhD, 312-238-6820, julio.hpavon@northwestern.edu
Laura Kinsey, MS, CCC-SLP, 3122385691, lkinsey@sralab.org
About this study
Official title: Modulating Language Networks in Patients With Post-stroke Aphasia Using Cortico-cortical Paired Associative Stimulation
The overall goal of this study is to evaluate whether stimulation of two brain areas alongside behavioral speech-language therapy increases connectivity to improve language functions in stroke-aphasia patients.
Read the detailed description
The brain is made up of networks that communicate with each other to help us think and communicate. After a stroke, networks between different areas of the brain can lose connection. In the case of aphasia, networks in the language areas of the brain are often disrupted. There is currently no "fix" to restore these specific language connections. However, transcranial magnetic stimulation (TMS) might help the areas reconnect through alternative pathways.
TMS is a non-invasive procedure (in other words, it takes place outside your body). A coil will be placed over your head. The coil sends magnetic pulses to your brain to stimulate, or excite, neurons. Most studies using TMS stimulate one area of the brain at a time, but this does not tell us how to improve the network connections between brain areas.
For this study, we plan to stimulate two language areas of the brain to improve these network connections. To do this, we will use a form of TMS called "cortico-cortical paired associative stimulation" (ccPAS). This type of TMS involves applying paired pulses to two different brain areas that have been "disconnected" from each other after a stroke. The pulses are delivered with a time difference, on other words, one pulse after another.
If you choose to participate, you will be randomly assigned to one of two groups. There is a 50% chance you will receive active brain stimulation with speech-language therapy and a 50% chance that you will receive inactive or sham stimulation (no brain stimulation) along with speech-language therapy. Neither you nor the clinician on the research project will choose - or know - which group you are assigned to. Only the person administering the stimulation will know.
- Being tested
- Cortico-cortical paired associative stimulation, Sham cortico-cortical paired associative stimulation
- Keywords
- Transcranial Magnetic Stimulation, Stroke Aphasia, Language, Functional Magnetic Resonance Imaging
- 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.
Cortico-cortical paired associative stimulationDevice
Two brain areas will be stimulated with transcranial magnetic stimulation pulses. The pulses will be delivered with a time difference, on other words, one pulse after another.
Sham cortico-cortical paired associative stimulationDevice
Two brain areas will be stimulated with sham transcranial magnetic stimulation. The sham pulses will be delivered with a time difference, on other words, one pulse after another.
| Study group | Role | What they receive |
|---|---|---|
| ccPAS group | Experimental | Patients under this group will receive ccPAS followed by speech-language therapy. Receives: Device: Cortico-cortical paired associative stimulation |
| Sham ccPAS group | Sham comparator | Patients under this group will receive sham ccPAS followed by speech-language therapy. Receives: Device: Sham cortico-cortical paired associative stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional connectivity with resting-state functional magnetic resonance imaging (rs-fMRI)
A seed-based functional connectivity analysis will be carried out between the two stimulated brain areas. To assess the changes in effective connectivity, we will compare the seed-based connectivity values across sessions.
Measured: Before vs. after ccPAS/sham ccPAS, on Days 1, 5, and 10 of the ccPAS/sham ccPAS regimen. We also compare the responses from Day 1 vs. Day 10.
Secondary outcomes (4)
Changes in the Western Aphasia Battery-Revised (WAB-R) Reading subtest
The WAB-R Reading subtest will be administered to assess changes in overall reading ability pre- and post-intervention as well as at the 1-month follow-up.
Measured: Visit 1 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Changes in oral reading probes
Oral reading probes will be administered to assess changes in oral reading of trained and untrained sentence stimuli before/after intervention session 1, after intervention session 5, before/after intervention session 10, and at the 1-month follow-up.
Measured: Visit 3 (baseline, pre-intervention), Visit 7 (midpoint, of intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Changes on The Short-Form Philadelphia Naming Test (PNT)
The Short-Form Philadelphia Naming Test (PNT) will be administered to assess changes in overall naming ability before/after intervention session 1, before/after intervention session 10, and at the 1-month follow-up.
Measured: Visit 3 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Changes in production of connected speech using standardized expositional discourse stimuli (Broken Window and Cat in Tree picture scenes)
Discourse elicitation tasks (e.g., picture descriptions) will be administered to assess changes in overall discourse ability (e.g., correct information units, rate) before/after intervention session 1, before/after intervention session 10, and at the 1-month follow-up.
Measured: Visit 3 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start9 Jan 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Model description
- A parallel randomized study will be performed. Three patients will be randomly assigned to receive ccPAS followed by speech-language therapy or sham ccPAS followed by speech-language therapy. Whether the participant receives ccPAS or sham ccPAS alongside speech-language therapy will be determined, at random, using a randomized number generator and enrollment order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio C Hernandez Pavon, Shirley Ryan AbilityLab
- Investigators
- Julio Hernandez Pavon, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660304
- Sponsor's protocol ID
- STU00217734
- Status last verified
- Dec 2022
- First submitted
- 9 Nov 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Language Networks in Patients With Post-stroke Aphasia Using Cortico-cortical Paired Associative Stimulation
- ClinicalTrials.gov ID
- NCT05660304
- Acronym / sponsor ID
- STU00217734
- Keywords
- Transcranial Magnetic Stimulation, Stroke Aphasia, Language, Functional Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 9 Jan 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to evaluate whether stimulation of two brain areas alongside behavioral speech-language therapy increases connectivity to improve language functions in stroke-aphasia patients.
Detailed description
The brain is made up of networks that communicate with each other to help us think and communicate. After a stroke, networks between different areas of the brain can lose connection. In the case of aphasia, networks in the language areas of the brain are often disrupted. There is currently no "fix" to restore these specific language connections. However, transcranial magnetic stimulation (TMS) might help the areas reconnect through alternative pathways.
TMS is a non-invasive procedure (in other words, it takes place outside your body). A coil will be placed over your head. The coil sends magnetic pulses to your brain to stimulate, or excite, neurons. Most studies using TMS stimulate one area of the brain at a time, but this does not tell us how to improve the network connections between brain areas.
For this study, we plan to stimulate two language areas of the brain to improve these network connections. To do this, we will use a form of TMS called "cortico-cortical paired associative stimulation" (ccPAS). This type of TMS involves applying paired pulses to two different brain areas that have been "disconnected" from each other after a stroke. The pulses are delivered with a time difference, on other words, one pulse after another.
If you choose to participate, you will be randomly assigned to one of two groups. There is a 50% chance you will receive active brain stimulation with speech-language therapy and a 50% chance that you will receive inactive or sham stimulation (no brain stimulation) along with speech-language therapy. Neither you nor the clinician on the research project will choose - or know - which group you are assigned to. Only the person administering the stimulation will know.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A parallel randomized study will be performed. Three patients will be randomly assigned to receive ccPAS followed by speech-language therapy or sham ccPAS followed by speech-language therapy. Whether the participant receives ccPAS or sham ccPAS alongside speech-language therapy will be determined, at random, using a randomized number generator and enrollment order.
| Arm | Type | Receives |
|---|---|---|
| ccPAS group | Experimental | Device: Cortico-cortical paired associative stimulationPatients under this group will receive ccPAS followed by speech-language therapy. |
| Sham ccPAS group | Sham comparator | Device: Sham cortico-cortical paired associative stimulationPatients under this group will receive sham ccPAS followed by speech-language therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of non-fluent aphasia due to a single, left-hemisphere stroke
- ≧ six months post-stroke onset
- WAB-R Fluency, Grammatical Competence, and Paraphasias Score between 2-6
- 18+ years of age
- Premorbidly right-handed
Key exclusion criteria (14 listed)
- Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
- Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
- Surgical clips in the head or previous neurosurgery
- Any magnetic particles in the body
- Cochlear implants
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 |
|---|---|---|
| Cortico-cortical paired associative stimulationTwo brain areas will be stimulated with transcranial magnetic stimulation pulses. The pulses will be delivered with a time difference, on other words, one pulse after another. | Device | ccPAS group |
| Sham cortico-cortical paired associative stimulationTwo brain areas will be stimulated with sham transcranial magnetic stimulation. The sham pulses will be delivered with a time difference, on other words, one pulse after another. | Device | Sham ccPAS group |
Primary outcome
Changes in functional connectivity with resting-state functional magnetic resonance imaging (rs-fMRI)
Time frame: Before vs. after ccPAS/sham ccPAS, on Days 1, 5, and 10 of the ccPAS/sham ccPAS regimen. We also compare the responses from Day 1 vs. Day 10.
A seed-based functional connectivity analysis will be carried out between the two stimulated brain areas. To assess the changes in effective connectivity, we will compare the seed-based connectivity values across sessions.
4 secondary outcomes
Changes in the Western Aphasia Battery-Revised (WAB-R) Reading subtest
Time frame: Visit 1 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Changes in oral reading probes
Time frame: Visit 3 (baseline, pre-intervention), Visit 7 (midpoint, of intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Changes on The Short-Form Philadelphia Naming Test (PNT)
Time frame: Visit 3 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Changes in production of connected speech using standardized expositional discourse stimuli (Broken Window and Cat in Tree picture scenes)
Time frame: Visit 3 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Julio Hernandez Pavon, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cortico-cortical paired associative stimulation in people with Stroke and Aphasia, run by Shirley Ryan AbilityLab 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julio Hernandez Pavon, PhD (3122386820, julio.hpavon@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in functional connectivity with resting-state functional magnetic resonance imaging (rs-fMRI) (time frame: Before vs. after ccPAS/sham ccPAS, on Days 1, 5, and 10 of the ccPAS/sham ccPAS regimen. We also compare the responses from Day 1 vs. Day 10.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2022.