Studying Language With Brain Stimulation in Aphasia

NCT05660304 | Unknown FDA Device

• 1 other identifier: STU00217734
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Aphasia

Keywords

Transcranial Magnetic Stimulation; Stroke Aphasia; Language; Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Visit 1 (baseline, pre-intervention), Visit 12 (immediately post-intervention), and Visit 13 (maintenance, 1-month post-intervention).

• 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).

• 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).

• 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).

Study Arms (2)

ccPAS group

EXPERIMENTAL

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

Device: Cortico-cortical paired associative stimulation

Sham ccPAS group

SHAM COMPARATOR

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

Device: Sham cortico-cortical paired associative stimulation

Interventions

Cortico-cortical paired associative stimulation DEVICE

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.

ccPAS group

Sham cortico-cortical paired associative stimulation DEVICE

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.

Sham ccPAS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• + years of age
• Premorbidly right-handed
• English-speaking
• Ability to participate in fMRI / TMS protocol

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Aphasia; Language

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior

Study Officials

• Julio Hernandez Pavon, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julio Hernandez Pavon, PhD

CONTACT

3122386820; julio.hpavon@northwestern.edu

Laura Kinsey, MS, CCC-SLP

CONTACT

3122385691; lkinsey@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 21, 2022
• Study Start: January 9, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)