What side effects are associated with this type of intervention?

Common side effects of non-invasive brain stimulation treatments for aphasia, such as tACS, tDCS, and rTMS, include headaches, scalp discomfort, tingling sensations, and occasionally skin irritation. Serious adverse effects are rare but can include seizures, especially in those with a predisposition to epilepsy. These treatments are generally safe when administered under medical supervision.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs or neuromodulation techniques like transcranial alternating current stimulation (tACS) explicitly approved for the treatment of aphasia. However, various neuromodulation therapies, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), have been explored in clinical trials for their potential to enhance neural plasticity and improve language functions in aphasia patients. These treatments aim to modulate neuronal activity and connectivity, similar to the goals of tACS.

What other types of research exist?

Promising, novel alternatives to tACS for aphasia patients include Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct-Current Stimulation (tDCS). Both have shown potential in modulating neuronal activity and enhancing neural plasticity and connectivity.

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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

Must not have

History of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate changes monitored after 20 minutes of tacs of each type

Summary

This study is evaluating whether a type of electrical stimulation may help improve language recovery for individuals who have had a stroke.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate changes monitored after 20 minutes of tacs of each type for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

tACS frequency-dependent changes in language performance on object and action naming tasks

tACS frequency-dependent neurophysiological changes

Secondary study objectives

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Aphasia treatments that modulate neuronal activity, such as Transcranial Alternating Current Stimulation (tACS), work by enhancing neural plasticity and connectivity. tACS applies a low-intensity electrical current to the scalp, which can synchronize neuronal firing patterns and strengthen neural networks involved in language processing. This is crucial for aphasia patients as it can potentially restore or improve language functions by promoting the reorganization of brain areas responsible for speech and comprehension. Enhancing neural plasticity and connectivity helps the brain adapt and compensate for damaged regions, offering a promising avenue for recovery.

Recent Trends in the Use of Electrical Neuromodulation in Parkinson's Disease.