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Brain Stimulation
Brain Stimulation for Aphasia
N/A
Recruiting
Led By Julio Hernandez Pavon, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 3 (baseline, pre-intervention), visit 7 (midpoint, of intervention), visit 12 (immediately post-intervention), and visit 13 (maintenance, 1-month post-intervention).
Awards & highlights
Study Summary
This trial will look at how brain stimulation and speech therapy can help stroke patients with language problems.
Who is the study for?
This trial is for adults over 18 who had a stroke at least six months ago, resulting in non-fluent aphasia. Participants must be English-speaking, previously right-handed, and able to undergo brain scans and stimulation. They can't join if they have metal implants, heart devices, significant claustrophobia or other major diseases; use alcohol or nicotine before visits; take certain medications that lower seizure threshold; or have a history of severe head trauma or seizures.Check my eligibility
What is being tested?
The study tests whether stimulating two specific brain areas while undergoing speech-language therapy helps improve language skills in people with aphasia after a stroke. One group receives real brain stimulation (cortico-cortical paired associative stimulation), while the other gets a sham (fake) treatment for comparison.See study design
What are the potential side effects?
Potential side effects may include discomfort from the stimulation device, headache, lightheadedness, twitching muscles during stimulation sessions and rarely seizures due to the electrical nature of the intervention.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 3 (baseline, pre-intervention), visit 7 (midpoint, of intervention), visit 12 (immediately post-intervention), and visit 13 (maintenance, 1-month post-intervention).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 3 (baseline, pre-intervention), visit 7 (midpoint, of intervention), visit 12 (immediately post-intervention), and visit 13 (maintenance, 1-month post-intervention).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in functional connectivity with resting-state functional magnetic resonance imaging (rs-fMRI)
Secondary outcome measures
Changes in oral reading probes
Changes in production of connected speech using standardized expositional discourse stimuli (Broken Window and Cat in Tree picture scenes)
Changes in the Western Aphasia Battery-Revised (WAB-R) Reading subtest
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ccPAS groupExperimental Treatment1 Intervention
Patients under this group will receive ccPAS followed by speech-language therapy.
Group II: Sham ccPAS groupPlacebo Group1 Intervention
Patients under this group will receive sham ccPAS followed by speech-language therapy.
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,875 Total Patients Enrolled
69 Trials studying Stroke
6,335 Patients Enrolled for Stroke
Julio Hernandez Pavon, PhDPrincipal InvestigatorShirley Ryan AbilityLab
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a cochlear implant.You have a strong fear of small, enclosed spaces.You have Ménière's disease.Your score for speaking, grammar, and word mix-ups should be between 2 and 6.You have a serious health condition like heart disease, cancer, or mental illness.You are not allowed to use drugs that are not prescribed by a doctor, like recreational marijuana.You were right-handed before the study.You are taking certain medications that can increase the risk of seizures, like some antipsychotic or antidepressant drugs.You have difficulty speaking due to a stroke on the left side of your brain.You have metal objects in your body or metallic particles in your eye.You have had surgery on your head before and have surgical clips inside.You have a history of epilepsy or seizures.You have a prosthetic heart valve.You had a stroke more than six months ago.You have any magnetic particles in your body.You have had a serious head injury with long-lasting unconsciousness or ongoing neurological problems.
Research Study Groups:
This trial has the following groups:- Group 1: ccPAS group
- Group 2: Sham ccPAS group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for the trial participants?
"According to clinicaltrials.gov, this medical study has begun recruiting patients and is open for enrollment. The initial posting date was September 1st 2023 while the most recent edit occured on December 20th 2022."
Answered by AI
What is the maximum number of participants being accepted into this clinical trial?
"Indeed, the information on clinicaltrials.gov shows that this research is still open to recruiting participants. The trial was initially published on September 1st 2023 and has been revised as of December 20th 2022. A total of 10 individuals are expected to be recruited from only one site."
Answered by AI
Who else is applying?
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
My sister had a stroke in January 2023. She’s only 38 years old now, and her personality and life pre stroke revolved so much on communicating with people. She wants nothing more than to have her ability to speak back.
PatientReceived no prior treatments
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