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Studying Language With Brain Stimulation in Aphasia

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Recruiting
CT.gov ID
NCT05660304
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
11.7
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cortico-cortical paired associative stimulation
  • Device: Sham cortico-cortical paired associative stimulation
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (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.
Primary Purpose:
Treatment
Official Title:
Modulating Language Networks in Patients With Post-stroke Aphasia Using Cortico-cortical Paired Associative Stimulation
Anticipated Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ccPAS group

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

Device: Cortico-cortical paired associative stimulation
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 Comparator: Sham ccPAS group

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

Device: Sham cortico-cortical paired associative stimulation
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in functional connectivity with resting-state functional magnetic resonance imaging (rs-fMRI) [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.

Secondary Outcome Measures

  1. Changes in the Western Aphasia Battery-Revised (WAB-R) Reading subtest [Visit 1 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).]

    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.

  2. Changes in oral reading probes [Visit 3 (baseline, pre-intervention), Visit 7 (midpoint, of intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).]

    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.

  3. Changes on The Short-Form Philadelphia Naming Test (PNT) [Visit 3 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).]

    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.

  4. Changes in production of connected speech using standardized expositional discourse stimuli (Broken Window and Cat in Tree picture scenes) [Visit 3 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Diagnosis of non-fluent aphasia due to a single, left-hemisphere stroke

  2. ≧ six months post-stroke onset

  3. WAB-R Fluency, Grammatical Competence, and Paraphasias Score between 2-6

  4. 18+ years of age

  5. Premorbidly right-handed

  6. English-speaking

  7. Ability to participate in fMRI / TMS protocol

Exclusion Criteria:

  1. Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps

  2. Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye

  3. Surgical clips in the head or previous neurosurgery

  4. Any magnetic particles in the body

  5. Cochlear implants

  6. Prosthetic heart valves

  7. Epilepsy or any other type of seizure history

  8. History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)

  9. Significant other disease (heart disease, malignant tumors, mental disorders)

  10. Significant claustrophobia

  11. Ménière's disease

  12. 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

  13. Non-prescribed drug use, for instance recreational marijuana

  14. Unable to refrain from using any alcohol and nicotine products for at least 24 hours before the study Visits.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shirley Ryan AbilityLab Chicago Illinois United States 60611

Sponsors and Collaborators

  • Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: Julio Hernandez Pavon, PhD, Shirley Ryan AbilityLab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Julio C Hernandez Pavon, Research Scientist, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier:
NCT05660304
Other Study ID Numbers:
  • STU00217734
First Posted:
Dec 21, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Julio C Hernandez Pavon, Research Scientist, Shirley Ryan AbilityLab
Transcranial Magnetic Stimulation
Stroke Aphasia
Language
Functional Magnetic Resonance Imaging
Additional relevant MeSH terms:
Stroke
Aphasia

Study Results

No Results Posted as of Dec 21, 2022