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Studying Language With Brain Stimulation in Aphasia

Primary Purpose

Stroke, Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cortico-cortical paired associative stimulation
Sham cortico-cortical paired associative stimulation
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Transcranial Magnetic Stimulation, Stroke Aphasia, Language, Functional Magnetic Resonance Imaging

Eligibility Criteria

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

Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ccPAS group

Sham ccPAS group

Arm Description

Patients under this group will receive ccPAS followed by speech-language therapy.

Patients under this group will receive sham ccPAS followed by speech-language therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 9, 2022
Last Updated
December 20, 2022
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT05660304
Brief Title
Studying Language With Brain Stimulation in Aphasia
Official Title
Modulating Language Networks in Patients With Post-stroke Aphasia Using Cortico-cortical Paired Associative Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
Transcranial Magnetic Stimulation, Stroke Aphasia, Language, Functional Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Because of the nature of the study, study personnel administering brain stimulation cannot be masked regarding whether the participant receives ccPAS or sham ccPAS. To minimize bias, neither the participant nor the speech-language pathologist will have knowledge of which group the participant is assigned to. However, the researcher administering ccPAS or sham ccPAS will know which intervention is applied.
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ccPAS group
Arm Type
Experimental
Arm Description
Patients under this group will receive ccPAS followed by speech-language therapy.
Arm Title
Sham ccPAS group
Arm Type
Sham Comparator
Arm Description
Patients under this group will receive sham ccPAS followed by speech-language therapy.
Intervention Type
Device
Intervention Name(s)
Cortico-cortical paired associative stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham cortico-cortical paired associative stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in functional connectivity with resting-state functional magnetic resonance imaging (rs-fMRI)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Changes in the Western Aphasia Battery-Revised (WAB-R) Reading subtest
Description
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.
Time Frame
Visit 1 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Title
Changes in oral reading probes
Description
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.
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).
Title
Changes on The Short-Form Philadelphia Naming Test (PNT)
Description
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.
Time Frame
Visit 3 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).
Title
Changes in production of connected speech using standardized expositional discourse stimuli (Broken Window and Cat in Tree picture scenes)
Description
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.
Time Frame
Visit 3 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julio Hernandez Pavon, PhD
Phone
3122386820
Email
julio.hpavon@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Kinsey, MS, CCC-SLP
Phone
3122385691
Email
lkinsey@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Hernandez Pavon, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Hernandez Pavon, PhD
Phone
312-238-6820
Email
julio.hpavon@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Laura Kinsey, MS, CCC-SLP
Phone
3122385691
Email
lkinsey@sralab.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Studying Language With Brain Stimulation in Aphasia

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