NCT05660304

Studying Language With Brain Stimulation in Aphasia

Modulating Language Networks in Patients With Post-stroke Aphasia Using Cortico-cortical Paired Associative Stimulation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Aphasia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-01-09
• Primary completion: 2023-08-31
• Completion: 2023-12-31
• First posted: 2022-12-21
• Last updated: 2022-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study