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Behavioural Intervention
tACS for Aphasia After Stroke
N/A
Recruiting
Led By Priyanka Shah-Basak, PhD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stroke Patients: Fluent in English
Healthy Controls: No history of neurological or psychiatric disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate changes monitored after 20 minutes of tacs of each type
Awards & highlights
Study Summary
This trial will test whether electrical stimulation can help improve language skills after a stroke, as well as in healthy people.
Who is the study for?
This trial is for adults who have had a stroke and are experiencing language difficulties (aphasia), as well as healthy adults without neurological issues. Participants must be fluent in English, at least 18 years old, and right-handed if they've had a stroke. They can't join if they have severe sensory impairments, untreated psychiatric diseases, unstable medical conditions, metal implants in the skull, or history of seizures or dyslexia.Check my eligibility
What is being tested?
The study is testing three types of transcranial alternating current stimulation (tACS): one with a frequency of 10-Hz, another with 40-Hz, and a sham (placebo) treatment to see how they affect language recovery after stroke and general language functions.See study design
What are the potential side effects?
Potential side effects from tACS may include mild headaches or discomfort at the electrode sites on the scalp. There's also a small risk of inducing seizures but this is rare especially in individuals without any seizure history.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fluent in English.
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I have never had a neurological or psychiatric disorder.
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I have been diagnosed with speech difficulties after a stroke.
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I am 18 years old or older and have had a stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediate changes monitored after 20 minutes of tacs of each type
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate changes monitored after 20 minutes of tacs of each type
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
tACS frequency-dependent changes in language performance on object and action naming tasks
tACS frequency-dependent neurophysiological changes
Secondary outcome measures
Individual differences in tACS responsiveness
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: tACS 40 Hz high frequencyExperimental Treatment1 Intervention
High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS with 40-Hz stimulation for 20-minutes with 1 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes.
Group II: tACS 10 Hz low frequencyExperimental Treatment1 Intervention
High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS with 10-Hz stimulation for 20-minutes with 1 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes.
Group III: tACS shamPlacebo Group1 Intervention
High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the active tACS groups.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,533 Total Patients Enrolled
6 Trials studying Aphasia
483 Patients Enrolled for Aphasia
Priyanka Shah-Basak, PhDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
135 Total Patients Enrolled
1 Trials studying Aphasia
135 Patients Enrolled for Aphasia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures.I am fluent in English.You have conditions that make it unsafe for you to have an MRI or tACS.I have never had a neurological or psychiatric disorder.Patients who primarily use their right hand for activities.You have serious problems with thinking, hearing, or seeing that would make it difficult to do tests related to thinking and language.You have a serious untreated or unstable mental health condition.You have a heart device like a pacemaker or cardiac stimulator.You have metal implants in your skull.I have been diagnosed with speech difficulties after a stroke.I am 18 years old or older and healthy.You have had dyslexia or other learning disabilities in the past.I am 18 years old or older and have had a stroke.
Research Study Groups:
This trial has the following groups:- Group 1: tACS sham
- Group 2: tACS 10 Hz low frequency
- Group 3: tACS 40 Hz high frequency
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 this research protocol recruiting participants at present?
"Affirmative. On clinicaltrials.gov, it is indicated that this medical trial has been advertised since January 4th 2020 and was most recently revised on September 1st 2022. This research project necessitates the enrollment of 50 patients from a single site."
Answered by AI
What criteria must prospective participants fulfill to be eligible for this clinical research?
"For this trial, a cohort of 50 participants aged between 18 and 85 with verified stroke diagnoses are required. Additional eligibility criteria include proficiency in the English language, absence of neurological/psychiatric disorders, right-handedness, and an interval of one month or more since onset for those diagnosed with post-stroke aphasia."
Answered by AI
Does this clinical trial offer enrollment for individuals of advanced age?
"As specified by the inclusion criteria of this trial, only those between 18 and 85 years old are eligible to participate. For minors under the age of 18, there are 42 other trials available while 1063 studies have been designed for seniors over 65."
Answered by AI
What is the current enrollment quota for this clinical investigation?
"That is correct. Evidenced on clinicaltrials.gov, this medical trial was initially created on April 1st 2020 and is still actively recruiting patients to participate in the study at one location with a target of 50 participants."
Answered by AI
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